Chronic Hepatitis BPhase 2NCT03180619
Study to Evaluate the Safety and Efficacy of Switching to Tenofovir Alafenamide (TAF) From Tenofovir Disoproxil Fumarate (TDF) and/or Other Oral Antiviral Treatment (OAV)
A Phase 2 study testing TAF in people with Chronic Hepatitis B, run by Gilead Sciences at 30 sites in 8 countries.
Trial summary
The primary objective of this study is to evaluate the safety and tolerability and virologic response of tenofovir alafenamide (TAF) in virologically suppressed chronic hepatitis B participants with renal and/or hepatic impairment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- TAF
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 30 sitesin 8 countries
- Study dates
- 29 Jun 2017to 4 Sep 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All Participants (Parts A and B):
- Adult male or non-pregnant female individuals
- Documented evidence of chronic HBV infection
- Alanine aminotransferase (ALT) ≤ 10 × upper limit of normal (ULN)
- Part A Only (renal impairment):
- Maintained on TDF and/or other OAV treatment(s) for CHB for at least 48 weeks and with viral suppression (HBV deoxyribonucleic acid [DNA] < lower limit of quantitation [LLOQ]) for ≥ 6 months prior to screening
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- All individuals must have HBV DNA < 20 International units per milliliter (IU/mL) at screening by central laboratory
- Both Hepatitis B e-Antigen (HBeAg) positive and negative individuals are eligible to participate
- Moderate renal impairment (30 milliliters per minute [mL/min] ≤ estimated glomerular filtration rate by the cockcroft-gault formula [eGFRcg] ≤ 59 mL/min), severe renal impairment (15 mL/min ≤ eGFRcg < 30 mL/min) or end stage renal disease (ESRD) (eGFR < 15 mL/min) maintained on hemodialysis (HD)
- Stable renal function (for participants with moderate or severe impairment): serum creatinine measured at least once within three months prior to screening. The measurement difference between the value measured within three months prior to screening versus the screening value must be ≤ 25% of the screening value
- Part B Only (hepatic impairment):
- Maintained on TDF and/or other OAV(s) for CHB for at least 48 weeks and with viral suppression (HBV DNA < LLOQ) for ≥ 6 months prior to screening
- All individuals must have HBV DNA < 20 IU/mL at screening by central laboratory
- Both HBeAg positive and negative individuals are eligible to participate
- Child-pugh-turcotte (CPT) score of 7-12 (inclusive) OR a past history of CPT score ≥ 7 and any CPT score ≤ 12 at screening
- eGFRCG ≥ 30 mL/min using the Cockcroft-Gault equation
Who cannot join
- All Individuals (Parts A \& B):
- Women who are breastfeeding or who believe they may wish to become pregnant during the course of the study
- Males and females of reproductive potential who are unwilling to use an "effective", protocol-specified method(s) of contraception during the study
- Co-infection with hepatitis C virus (HCV), human immunodeficiency virus (HIV), or hepatitis D virus (HDV)
- Prior Interferon (IFN) use within 6 months of screening
- Evidence of hepatocellular carcinoma
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- Received solid organ or bone marrow transplant
- Significant cardiovascular, pulmonary, or neurological disease
- Malignancy within 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (basal cell skin cancer, etc.). Individuals under evaluation for possible malignancy are not eligible
- Currently receiving therapy with immunomodulators (e.g. corticosteroids), nephrotoxic agents, or agents capable of modifying renal excretion
- Known hypersensitivity to study drugs, metabolites, or formulation excipients
- Current alcohol or substance abuse judged by the investigator to potentially interfere with individual's compliance
- Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the individual unsuitable for the study or unable to comply with dosing requirements.
- Part A Only (Renal Impairment):
- Current or historical evidence of clinical hepatic decompensation (e.g., ascites, encephalopathy or variceal hemorrhage)
- Abnormal hematological and biochemical parameters, including:
- Hemoglobin < 9 grams per deciliter (g/dL)
- Absolute neutrophil count < 750/cubic millimeter (mm^3)
- Platelets ≤ 50,000/mm^3
- Aspartate aminotransferase (AST) > 10 × ULN
- Albumin < 3.0 g/dL
- Total bilirubin > 2.5 × ULN
- International normalized ratio of prothrombin time (INR) > 1.5 × ULN (unless stable on anticoagulant regimen)
- Individuals with ESRD (i.e. eGFRcg < 15 mL/min) not on HD, or those on other forms of renal replacement therapy (i.e. peritoneal dialysis)
- Part B Only (Hepatic Impairment):
- Active variceal bleeding within 6 months or prior placement of a portosystemic shunt (such as transjugular intrahepatic portosystemic shunt [TIPS])
- History of hepatorenal syndrome, hepatopulmonary syndrome, Grade 3 or Grade 4 hepatic encephalopathy, or spontaneous bacterial peritonitis within 6 months of screening
- Grade 2 hepatic encephalopathy at screening
- Model for end-stage liver disease (MELD) score ≥ 30
- Abnormal hematological and biochemical parameters, including
- Absolute neutrophil count < 750/mm^3
- Platelets < 30,000/mm^3
- Hemoglobin < 8.0 g/dL
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
30 sites in 8 countries.
30 sites in 8 countries
Taiwan8 sites
Changhua Christian Hospital
Changhua, 500
Ditmanson Medical Foundation Chia-Yi Christian Hospital
Chiayi City, 60002
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301
Taichung Veterans Genl Hosp
Taichung, 40705
National Taiwan University Hospital
Taipei, 10001
Veterans General Hospital-Taipei
Taipei, 11217
Chang Gung Medical Foundation, Linkou Chang Gung Memorial Hospital
Taoyuan City, 333
Canada5 sites
University of Calgary Liver Unit
Calgary, T2N4Z6
Centre de Recherche du Centre Hospitalier de l'Universite de Montreal
Montreal, H2X 0A9
University Health Network,Toronto general Hospital,Toronto centre for liver disease
Toronto, M5G 2C4
Toronto Liver Centre
Toronto, M6H 3M1
(G.I.R.I.) GI Research Institute
Vancouver, V6Z 2K5
United States4 sites
Henry Ford Health System
Detroit, Michigan, 48202
Coalition of Inclusive Medicine
Los Angeles, California, 90020
Silicon Valley Research Institute, Inc
San Jose, California, 95128
Harborview Medical Center
Seattle, Washington, 98104
South Korea4 sites
Dong-A University Hospital
Busan, 49201
Pusan National University Hospital
Busan, 49241
Asan Medical Center
Seoul, 05505
Yonsei University Health System, Severance Hospital
Seoul, 120-752
Hong Kong3 sites
Princess Margaret Hospital
Kowloon
Prince of Wales Hospital
Shatin, NT
Alice Ho Miu Ling Nethersole Hospital
Tai Po
Italy3 sites
Dipartimento di Scienze Mediche e Chirurgiche (DIMEC) AOU Policlinico S.Orsola-Malpighi di Bologna
Bologna, 40138
UOC Gastroenterol-Epatol.-Fondazione IRCCS Ca Granda
Milan, 20122
U.O. Medicina Generale Epatologia IRCCS Humanitas Centro di Ricerca Traslazionale in Epatologia
Rozzano, Milan, 20089
United Kingdom2 sites
Nottingham University Hospital
London, NG7 2UH
King's College Hospital NHS Foundation Trust
London, SE5 9RS
About this study
Official title: A Phase 2, Open-label Study to Evaluate the Safety and Efficacy of Switching to Tenofovir Alafenamide (TAF) From Tenofovir Disoproxil Fumarate (TDF) and/or Other Oral Antiviral Treatment (OAV) in Virologically Suppressed Chronic Hepatitis B Subjects With Renal and/or Hepatic Impairment
The primary objective of this study is to evaluate the safety and tolerability and virologic response of tenofovir alafenamide (TAF) in virologically suppressed chronic hepatitis B participants with renal and/or hepatic impairment.
- Conditions
- Chronic Hepatitis B
- Being tested
- TAF
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAFDrug
Also called Vemlidy®
Tablet administered orally once daily
| Study group | Role | What they receive |
|---|---|---|
| Part A (Renal Impairment): Moderate or Severe Renal Impairment | Experimental | Participants with chronic hepatitis B (CHB) and moderate or severe renal impairment who were virologically suppressed and taking tenofovir disoproxil fumarate (TDF), a TDF-containing anti-hepatitis B virus (HBV) regimen, or other oral antivirals (OAVs), will switch to tenofovir alafenamide (TAF) and receive TAF 25 milligram (mg) tablet once daily orally for 96 weeks. Receives: Drug: TAF |
| Part A (Renal Impairment): End Stage Renal Disease | Experimental | Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, will switch to TAF and receive TAF 25 mg tablet once daily orally for 96 weeks. Receives: Drug: TAF |
| Part B: Hepatic Impairment | Experimental | Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, will switch to TAF and receive TAF 25 mg tablet once daily orally for 96 weeks. Receives: Drug: TAF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving Virologic Response (Plasma Hepatitis B Virus [HBV] Deoxyribonucleic Acid [DNA] < 20 IU/mL) at Week 24
The percentage of participants with HBV DNA < 20 IU/mL at Week 24 was determined by the Missing = Failure (M = F) approach.
Measured: Week 24
Percentage of Participants Who Experienced Graded Treatment-Emergent Adverse Events (AEs) at Week 24
Treatment-emergent AEs were defined as:
- Any AEs with an onset date on or after the study drug start date and no later than the study drug stop date + 3 days after permanent discontinuation of study drug;
- Any AEs with onset date on or after the study drug start date for those who have not permanently discontinued study drug;
- Any AEs leading to premature discontinuation of study drug.
The most severe graded AE from all tests was counted for each participant.
Measured: Week 24
Percentage of Participants Who Experienced Graded Treatment-Emergent Laboratory Abnormalities at Week 24
Graded treatment-emergent laboratory abnormalities were defined as values that increased at least 1 toxicity grade from baseline at any postbaseline visit, up to and including the date of last dose of study drug + 3 days for participants who permanently discontinued study drug or the last available date in the database snapshot for participants who were on treatment at the time of the analysis.
The most severe graded abnormality from all tests was counted for each participant.
Measured: Week 24
Secondary outcomes (48)
Percentage of Participants Who Experienced Graded Treatment-Emergent AEs at Week 48
Treatment-emergent AEs were defined as: Any AEs with an onset date on or after the study drug start date and no later than the study drug stop date + 3 days after permanent discontinuation of study drug; Any AEs with onset date on or after the study drug start date for those who have not permanently discontinued study drug; Any AEs leading to premature discontinuation of study drug. The most severe graded AE from all tests was counted for each participant.
Measured: Week 48
Percentage of Participants Who Experienced Graded Treatment-Emergent AEs at Week 96
Treatment-emergent AEs were defined as: Any AEs with an onset date on or after the study drug start date and no later than the study drug stop date + 3 days after permanent discontinuation of study drug; Any AEs with onset date on or after the study drug start date for those who have not permanently discontinued study drug; Any AEs leading to premature discontinuation of study drug. The most severe graded AE from all tests was counted for each participant.
Measured: Week 96
Percentage of Participants Who Experienced Graded Treatment-Emergent Laboratory Abnormalities at Week 48
Graded treatment-emergent laboratory abnormalities were defined as values that increased at least 1 toxicity grade from baseline at any postbaseline visit, up to and including the date of last dose of study drug + 3 days for participants who permanently discontinued study drug or the last available date in the database snapshot for participants who were on treatment at the time of the analysis.
The most severe graded abnormality from all tests was counted for each participant.
Measured: Week 48
Percentage of Participants Who Experienced Graded Treatment-Emergent Laboratory Abnormalities at Week 96
Graded treatment-emergent laboratory abnormalities were defined as values that increased at least 1 toxicity grade from baseline at any post-baseline visit, up to and including the date of last dose of study drug + 3 days for participants who permanently discontinued study drug or the last available date in the database snapshot for participants who were on treatment at the time of the analysis. The most severe graded abnormality from all tests was counted for each participant.
Measured: Week 96
Change From Baseline in Estimated Glomerular Filtration Rate by the Cockcroft-Gault Formula (eGFRcg) in Participants With Moderate or Severe Renal Impairment and Hepatically Impaired Participants at Week 24
GFR is a measure of the rate at which blood is filtered by the kidney. Cockcroft-Gault is an equation (calculation) used to estimate GFR based on serum creatinine, weight, and gender. eGFRcg = (140 - age in years) x (body weight in kg) x (0.85 if female) divided by 72 x serum creatinine in mg/dL.
Moderate renal impairment= 30 mL/min ≤ eGFRCG ≤ 59 mL/min Severe renal impairment= 15 mL/min ≤ eGFRCG < 30 mL/min Change from baseline was calculated as the value at Week 24 minus the value at Baseline.
Measured: Baseline, Week 24
Change From Baseline in eGFRcg in Participants With Moderate or Severe Renal Impairment and Hepatically Impaired Participants at Week 48
GFR is a measure of the rate at which blood is filtered by the kidney. Cockcroft-Gault is an equation (calculation) used to estimate GFR based on serum creatinine, weight, and gender. eGFRcg = (140 - age in years) x (body weight in kg) x (0.85 if female) divided by 72 x serum creatinine in mg/dL.
Moderate renal impairment= 30 mL/min ≤ eGFRCG ≤ 59 mL/min Severe renal impairment= 15 mL/min ≤ eGFRCG < 30 mL/min Change from baseline was calculated as the value at Week 48 minus the value at Baseline.
Measured: Baseline, Week 48
Change From Baseline in eGFRcg in Participants With Moderate or Severe Renal Impairment and Hepatically Impaired Participants at Week 96
GFR is a measure of the rate at which blood is filtered by the kidney. Cockcroft-Gault is an equation (calculation) used to estimate GFR based on serum creatinine, weight, and gender. eGFRcg = (140 - age in years) x (body weight in kg) x (0.85 if female) divided by 72 x serum creatinine in mg/dL.
Moderate renal impairment= 30 mL/min ≤ eGFRCG ≤ 59 mL/min Severe renal impairment= 15 mL/min ≤ eGFRCG < 30 mL/min Change from baseline was calculated as the value at Week 96 minus the value at Baseline.
Measured: Baseline, Week 96
Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 24
Percent change = Change from baseline at a postbaseline visit/baseline * 100%.
Measured: Baseline, Week 24
Percent Change From Baseline in Hip BMD at Week 48
Percent change = Change from baseline at a postbaseline visit/baseline * 100%.
Measured: Baseline, Week 48
Percent Change From Baseline in Hip BMD at Week 96
Percent change = Change from baseline at a postbaseline visit/baseline * 100%.
Measured: Baseline, Week 96
Percent Change From Baseline in Spine BMD at Week 24
Percent change = Change from baseline at a postbaseline visit/baseline * 100%.
Measured: Baseline, Week 24
Percent Change From Baseline in Spine BMD at Week 48
Percent change = Change from baseline at a postbaseline visit/baseline * 100%.
Measured: Baseline, Week 48
Percent Change From Baseline in Spine BMD at Week 96
Percent change = Change from baseline at a postbaseline visit/baseline * 100%.
Measured: Baseline, Week 96
Percentage of Participants Achieving Virologic Response (Plasma HBV DNA < 20 IU/mL) at Week 48
The percentage of participants with HBV DNA < 20 IU/mL at Week 48 was determined by the Missing = Failure (M = F) approach.
Measured: Weeks 48
Percentage of Participants Achieving Virologic Response (Plasma HBV DNA < 20 IU/mL) at Week 96
The percentage of participants with HBV DNA < 20 IU/mL at Week 48 was determined by the Missing = Failure (M = F) approach.
Measured: Weeks 96
Percentage of Participants With Plasma HBV DNA < 20 IU/mL and Target Detected (≥ Lower Limit of Detection [LLOD]) at Week 24
The percentage of participants with HBV DNA < 20 IU/mL and target detected (≥ LLOD; i.e. 10 IU/mL) at Week 24 was determined by the M = F approach.
Measured: Week 24
Percentage of Participants With Plasma HBV DNA < 20 IU/mL and Target Detected (≥ LLOD) at Week 48
The percentage of participants with HBV DNA < 20 IU/mL and target detected (≥ LLOD; i.e. 10 IU/mL) at Week 48 was determined by the M = F approach.
Measured: Week 48
Percentage of Participants With Plasma HBV DNA < 20 IU/mL and Target Detected (≥ LLOD) at Week 96
The percentage of participants with HBV DNA < 20 IU/mL and target detected (≥ LLOD; i.e. 10 IU/mL) at Week 96 was determined by the M = F approach.
Measured: Week 96
Percentage of Participants With Plasma HBV DNA < 20 IU/mL and Target Not Detected (< LLOD) at Week 24
The percentage of participants with HBV DNA < 20 IU/mL and target not detected (< LLOD; i.e. 10 IU/mL) at Week 24 was determined by the M = F approach.
Measured: Week 24
Percentage of Participants With Plasma HBV DNA < 20 IU/mL and Target Not Detected (< LLOD) at Week 48
The percentage of participants with HBV DNA < 20 IU/mL and target not detected (< LLOD; i.e. 10 IU/mL) at Week 48 was determined by the M = F approach.
Measured: Weeks 48
Percentage of Participants With Plasma HBV DNA < 20 IU/mL and Target Not Detected (< LLOD) at Week 96
The percentage of participants with HBV DNA < 20 IU/mL and target not detected (< LLOD; i.e. 10 IU/mL) at Week 96 was determined by the M = F approach.
Measured: Weeks 96
Percentage of Participants With Serological Response: Loss of Hepatitis B s-Antigen (HBsAg) at Week 24
HBsAg loss was defined as HBsAg changing from positive at baseline to negative at a postbaseline. The M = F approach was used for this analysis.
Measured: Week 24
Percentage of Participants With Serological Response: Loss of HBsAg at Week 48
HBsAg loss was defined as HBsAg changing from positive at baseline to negative at a postbaseline. The M = F approach was used for this analysis.
Measured: Week 48
Percentage of Participants With Serological Response: Loss of HBsAg at Week 96
HBsAg loss was defined as HBsAg changing from positive at baseline to negative at a postbaseline. The M = F approach was used for this analysis.
Measured: Week 96
Percentage of Participants With Serological Response: Seroconversion to Anti-HBs at Week 24
HBsAg seroconversion was defined as HBsAg loss and HBsAb test changing from negative/missing at baseline to positive at a postbaseline visit. The M = F approach was used for this analysis.
Measured: Week 24
Percentage of Participants With Serological Response: Seroconversion to Anti-HBs at Week 48
HBsAg seroconversion was defined as HBsAg loss and HBsAb test changing from negative/missing at baseline to positive at a postbaseline visit. The M = F approach was used for this analysis.
Measured: Week 48
Percentage of Participants With Serological Response: Seroconversion to Anti-HBs at Week 96
HBsAg seroconversion was defined as HBsAg loss and HBsAb test changing from negative/missing at baseline to positive at a postbaseline visit. The M = F approach was used for this analysis.
Measured: Week 96
Percentage of Participants With Serological Response: Loss of HBeAg in HBeAg-Positive Participants at Week 24
HBeAg loss was defined as HBeAg changing from positive at baseline to negative at a postbaseline. The M = F approach was used for this analysis.
Measured: Week 24
Percentage of Participants With Serological Response: Loss of HBeAg in HBeAg-Positive Participants at Week 48
HBeAg loss was defined as HBeAg changing from positive at baseline to negative at a postbaseline. The M = F approach was used for this analysis.
Measured: Week 48
Percentage of Participants With Serological Response: Loss of HBeAg in HBeAg-Positive Participants at Week 96
HBeAg loss was defined as HBeAg changing from positive at baseline to negative at a postbaseline. The M = F approach was used for this analysis.
Measured: Week 96
Percentage of Participants With Serological Response: Seroconversion to Anti-HBe in HBeAg-Positive Participants at Week 24
HBeAg seroconversion was defined as HBeAg loss and HBeAb test changing from negative/missing at baseline to positive at a postbaseline visit. The M = F approach was used for this analysis.
Measured: Week 24
Percentage of Participants With Serological Response: Seroconversion to Anti-HBe in HBeAg-Positive Participants at Week 48
HBeAg seroconversion was defined as HBeAg loss and HBeAb test changing from negative/missing at baseline to positive at a postbaseline visit. The M = F approach was used for this analysis.
Measured: Week 48
Percentage of Participants With Serological Response: Seroconversion to Anti-HBe in HBeAg-Positive Participants at Week 96
HBeAg seroconversion was defined as HBeAg loss and HBeAb test changing from negative/missing at baseline to positive at a postbaseline visit. The M = F approach was used for this analysis.
Measured: Week 96
Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Week 24 by Central Laboratory and the American Association for the Study of Liver Diseases (AASLD) Criteria
Central laboratory ULN for ALT were as follows: ≤ 43 U/L for males aged 18 to < 69 years and ≤ 35 U/L for males aged ≥ 69 years; ≤ 34 U/L for females aged 18 to < 69 years and ≤ 32 U/L for females aged ≥ 69 years. The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males. The M = F approach was used for this analysis.
Measured: Week 24
Percentage of Participants With Normal ALT at Week 48 by Central Laboratory and the AASLD Criteria
Central laboratory ULN for ALT were as follows: ≤ 43 U/L for males aged 18 to < 69 years and ≤ 35 U/L for males aged ≥ 69 years; ≤ 34 U/L for females aged 18 to < 69 years and ≤ 32 U/L for females aged ≥ 69 years. The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males. The M = F approach was used for this analysis.
Measured: Week 48
Percentage of Participants With Normal ALT at Week 96 by Central Laboratory and the AASLD Criteria
Central laboratory ULN for ALT were as follows: ≤ 43 U/L for males aged 18 to < 69 years and ≤ 35 U/L for males aged ≥ 69 years; ≤ 34 U/L for females aged 18 to < 69 years and ≤ 32 U/L for females aged ≥ 69 years. The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males. The M = F approach was used for this analysis.
Measured: Week 96
Percentage of Participants With Normalized ALT at Week 24 by Central Laboratory and the AASLD Criteria
ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit. Central laboratory ULN for ALT were as follows: ≤ 43 U/L for males aged 18 to < 69 years and ≤ 35 U/L for males aged ≥ 69 years; ≤ 34 U/L for females aged 18 to < 69 years and ≤ 32 U/L for females aged ≥ 69 years. The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males. The M = F approach was used for this analysis.
Measured: Week 24
Percentage of Participants With Normalized ALT at Week 48 by Central Laboratory and the AASLD Criteria
ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit. Central laboratory ULN for ALT were as follows: ≤ 43 U/L for males aged 18 to < 69 years and ≤ 35 U/L for males aged ≥ 69 years; ≤ 34 U/L for females aged 18 to < 69 years and ≤ 32 U/L for females aged ≥ 69 years. The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males. The M = F approach was used for this analysis.
Measured: Week 48
Percentage of Participants With Normalized ALT at Week 96 by Central Laboratory and the AASLD Criteria
ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit. Central laboratory ULN for ALT were as follows: ≤ 43 U/L for males aged 18 to < 69 years and ≤ 35 U/L for males aged ≥ 69 years; ≤ 34 U/L for females aged 18 to < 69 years and ≤ 32 U/L for females aged ≥ 69 years. The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males. The M = F approach was used for this analysis.
Measured: Week 96
Change From Baseline in FibroTest® Score at Week 24
The FibroTest® score is used to assess liver fibrosis. Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis. Change from baseline was calculated as the value at Week 24 minus the value at Baseline.
Measured: Baseline, Week 24
Change From Baseline in FibroTest® Score at Week 48
The FibroTest® score is used to assess liver fibrosis. Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis. Change from baseline was calculated as the value at Week 48 minus the value at Baseline.
Measured: Baseline, Week 48
Change From Baseline in FibroTest® Score at Week 96
The FibroTest® score is used to assess liver fibrosis. Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis. Change from baseline was calculated as the value at Week 96 minus the value at Baseline.
Measured: Week 96
Change From Baseline in Child-Pugh-Turcotte (CPT) Score in Hepatically Impaired Participants at Week 24
CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15, with higher scores indicating a greater severity of disease.
Measured: Baseline, Week 24
Change From Baseline in CPT Score in Hepatically Impaired Participants at Week 48
CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15, with higher scores indicating a greater severity of disease.
Measured: Baseline, Week 48
Change From Baseline in CPT Score in Hepatically Impaired Participants at Week 96
CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15, with higher scores indicating a greater severity of disease.
Measured: Baseline, Week 96
Change From Baseline in Model for End-Stage Liver Disease (MELD) Score in Hepatically Impaired Participants at Week 24
MELD scores are used to assess prognosis and suitability for liver transplantation. Scores can range from 6 to 40, with higher scores indicating greater disease severity.
Measured: Baseline, Week 24
Change From Baseline in MELD Score in Hepatically Impaired Participants at Week 48
MELD scores are used to assess prognosis and suitability for liver transplantation. Scores can range from 6 to 40, with higher scores indicating greater disease severity.
Measured: Baseline, Week 48
Change From Baseline in MELD Score in Hepatically Impaired Participants at Week 96
MELD scores are used to assess prognosis and suitability for liver transplantation. Scores can range from 6 to 40, with higher scores indicating greater disease severity.
Measured: Baseline, Week 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2017
- Study start29 Jun 2017
- Primary completion27 Mar 2019
- Study completion4 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03180619
- Sponsor's protocol ID
- GS-US-320-4035
- Other IDs
- 2016-004625-16, 2016
- Status last verified
- Aug 2021
- First submitted
- 6 Jun 2017
- Last updated
- 27 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy
Publications
Lim YS, Lin CY, Heo J, Bae H, Chuang WL, Hui AJ, et al. Safety and Efficacy of Switching to Tenofovir Alafenamide in Virally Suppressed Chronic Hepatitis B Patients With Hepatic Impairment: Week-48 Results From a Phase 2 Open-label Study [Poster SAT442]. The Digital International Liver Congress (ILC); 2020 27-29 August.
Janssen HLA, Lampertico P, Chen CY, Heo J, Fournier C, Ahn SH, et al. Safety and Efficacy of Switching to Tenofovir Alafenamide in Virally Suppressed Chronic Hepatitis B Patients With Renal Impairment: Week-48 Results From a Phase 2 Open-label Study [Poster SAT429]. The Digital International Liver Congress (ILC); 2020 27-29 August.
Lim YS, Lampertico P, Bae H, Chuang WL, Heo J, Huang YH, et al. Switching From Tenofovir Disoproxil Fumarate or Other Oral Antiviral Therapy to Tenofovir Alafenamide in Virally Suppressed Chronic Hepatitis B Patients With Hepatic Impairment: Week 24 Efficacy and Safety Results From a Phase 2 Open-label Study [Poster 501]. AASLD: The Liver Meeting; 2019 08-12 November; Boston, MA.
Janssen HLA, Lim YS, Gane EJ, Fournier C, Ahn SH, Tsang O, et al. Efficacy and Safety of Switching to Tenofovir Alafenamide in Virally Suppressed Chronic Hepatitis B Patients With Renal Impairment: Week 24 Results From a Phase 2 Open-label Study [Poster 483]. AASLD: The Liver Meeting; 2019 08-12 November; Boston, MA.
Liu CJ, Lim YS, Chen CY, Chen CH, Huang YH, Lin CY, Lin CC, Yu ML, Abramov F, Yee LJ, Duan R, Flaherty JF, Su WW, Yang SS, Janssen HLA, Chuang WL. Switching to tenofovir alafenamide in virally-suppressed chronic hepatitis B patients with renal/hepatic impairment: Phase 2 study sub-analysis from Taiwan. J Formos Med Assoc. 2025 Jul 30:S0929-6646(25)00390-0. doi: 10.1016/j.jfma.2025.07.023. Online ahead of print.
PubMed 40744841Janssen HLA, Lim YS, Lampertico P, Heo J, Chen CY, Fournier C, Tsang TYO, Bae H, Chen CH, Coffin CS, Ahn SH, Trinh H, Flaherty JF, Abramov F, Zhao Y, Liu Y, Lau A, German P, Chuang WL, Agarwal K, Gane E. Switching to tenofovir alafenamide in patients with virologically suppressed chronic hepatitis B and renal or hepatic impairment: final week 96 results from an open-label, multicentre, phase 2 study. Lancet Gastroenterol Hepatol. 2024 Aug;9(8):718-733. doi: 10.1016/S2468-1253(24)00096-7. Epub 2024 Jun 17.
PubMed 38901444
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-label Study to Evaluate the Safety and Efficacy of Switching to Tenofovir Alafenamide (TAF) From Tenofovir Disoproxil Fumarate (TDF) and/or Other Oral Antiviral Treatment (OAV) in Virologically Suppressed Chronic Hepatitis B Subjects With Renal and/or Hepatic Impairment
- ClinicalTrials.gov ID
- NCT03180619
- Acronym / sponsor ID
- GS-US-320-4035
- Conditions
- Chronic Hepatitis B
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 29 Jun 2017 (actual)
- Primary completion
- 27 Mar 2019 (actual)
- Study completion
- 4 Sep 2020 (actual)
- First posted
- 8 Jun 2017 (actual)
- Results
- Posted 9 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the safety and tolerability and virologic response of tenofovir alafenamide (TAF) in virologically suppressed chronic hepatitis B participants with renal and/or hepatic impairment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part A (Renal Impairment): Moderate or Severe Renal Impairment | Experimental | Drug: TAFParticipants with chronic hepatitis B (CHB) and moderate or severe renal impairment who were virologically suppressed and taking tenofovir disoproxil fumarate (TDF), a TDF-containing anti-hepatitis B virus (HBV) regimen, or other oral antivirals (OAVs), will switch to tenofovir alafenamide (TAF) and receive TAF 25 milligram (mg) tablet once daily orally for 96 weeks. |
| Part A (Renal Impairment): End Stage Renal Disease | Experimental | Drug: TAFParticipants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, will switch to TAF and receive TAF 25 mg tablet once daily orally for 96 weeks. |
| Part B: Hepatic Impairment | Experimental | Drug: TAFParticipants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, will switch to TAF and receive TAF 25 mg tablet once daily orally for 96 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Adult male or non-pregnant female individuals
- Documented evidence of chronic HBV infection
- Alanine aminotransferase (ALT) ≤ 10 × upper limit of normal (ULN)
- Maintained on TDF and/or other OAV treatment(s) for CHB for at least 48 weeks and with viral suppression (HBV deoxyribonucleic acid [DNA] < lower limit of quantitation [LLOQ]) for ≥ 6 months prior to screening
- Moderate renal impairment (30 milliliters per minute [mL/min] ≤ estimated glomerular filtration rate by the cockcroft-gault formula [eGFRcg] ≤ 59 mL/min), severe renal impairment (15 mL/min ≤ eGFRcg < 30 mL/min) or end stage renal disease (ESRD) (eGFR < 15 mL/min) maintained on hemodialysis (HD)
Key exclusion criteria (34 listed)
- Women who are breastfeeding or who believe they may wish to become pregnant during the course of the study
- Males and females of reproductive potential who are unwilling to use an "effective", protocol-specified method(s) of contraception during the study
- Co-infection with hepatitis C virus (HCV), human immunodeficiency virus (HIV), or hepatitis D virus (HDV)
- Prior Interferon (IFN) use within 6 months of screening
- Evidence of hepatocellular carcinoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAFAlso: Vemlidy®Tablet administered orally once daily | Drug | Part A (Renal Impairment): End Stage Renal Disease, Part A (Renal Impairment): Moderate or Severe Renal Impairment, Part B: Hepatic Impairment |
Primary outcome
Percentage of Participants Achieving Virologic Response (Plasma Hepatitis B Virus [HBV] Deoxyribonucleic Acid [DNA] < 20 IU/mL) at Week 24
Time frame: Week 24
The percentage of participants with HBV DNA < 20 IU/mL at Week 24 was determined by the Missing = Failure (M = F) approach.
Percentage of Participants Who Experienced Graded Treatment-Emergent Adverse Events (AEs) at Week 24
Time frame: Week 24
Treatment-emergent AEs were defined as: * Any AEs with an onset date on or after the study drug start date and no later than the study drug stop date + 3 days after permanent discontinuation of study drug; * Any AEs with onset date on or after the study drug start date for those who have not permanently discontinued study drug; * Any AEs leading to premature discontinuation of study drug. The most severe graded AE from all tests was counted for each participant.
Percentage of Participants Who Experienced Graded Treatment-Emergent Laboratory Abnormalities at Week 24
Time frame: Week 24
Graded treatment-emergent laboratory abnormalities were defined as values that increased at least 1 toxicity grade from baseline at any postbaseline visit, up to and including the date of last dose of study drug + 3 days for participants who permanently discontinued study drug or the last available date in the database snapshot for participants who were on treatment at the time of the analysis. The most severe graded abnormality from all tests was counted for each participant.
48 secondary outcomes
Percentage of Participants Who Experienced Graded Treatment-Emergent AEs at Week 48
Time frame: Week 48
Percentage of Participants Who Experienced Graded Treatment-Emergent AEs at Week 96
Time frame: Week 96
Percentage of Participants Who Experienced Graded Treatment-Emergent Laboratory Abnormalities at Week 48
Time frame: Week 48
Percentage of Participants Who Experienced Graded Treatment-Emergent Laboratory Abnormalities at Week 96
Time frame: Week 96
Change From Baseline in Estimated Glomerular Filtration Rate by the Cockcroft-Gault Formula (eGFRcg) in Participants With Moderate or Severe Renal Impairment and Hepatically Impaired Participants at Week 24
Time frame: Baseline, Week 24
Change From Baseline in eGFRcg in Participants With Moderate or Severe Renal Impairment and Hepatically Impaired Participants at Week 48
Time frame: Baseline, Week 48
Change From Baseline in eGFRcg in Participants With Moderate or Severe Renal Impairment and Hepatically Impaired Participants at Week 96
Time frame: Baseline, Week 96
Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 24
Time frame: Baseline, Week 24
Percent Change From Baseline in Hip BMD at Week 48
Time frame: Baseline, Week 48
Percent Change From Baseline in Hip BMD at Week 96
Time frame: Baseline, Week 96
Percent Change From Baseline in Spine BMD at Week 24
Time frame: Baseline, Week 24
Percent Change From Baseline in Spine BMD at Week 48
Time frame: Baseline, Week 48
Percent Change From Baseline in Spine BMD at Week 96
Time frame: Baseline, Week 96
Percentage of Participants Achieving Virologic Response (Plasma HBV DNA < 20 IU/mL) at Week 48
Time frame: Weeks 48
Percentage of Participants Achieving Virologic Response (Plasma HBV DNA < 20 IU/mL) at Week 96
Time frame: Weeks 96
Percentage of Participants With Plasma HBV DNA < 20 IU/mL and Target Detected (≥ Lower Limit of Detection [LLOD]) at Week 24
Time frame: Week 24
Percentage of Participants With Plasma HBV DNA < 20 IU/mL and Target Detected (≥ LLOD) at Week 48
Time frame: Week 48
Percentage of Participants With Plasma HBV DNA < 20 IU/mL and Target Detected (≥ LLOD) at Week 96
Time frame: Week 96
Percentage of Participants With Plasma HBV DNA < 20 IU/mL and Target Not Detected (< LLOD) at Week 24
Time frame: Week 24
Percentage of Participants With Plasma HBV DNA < 20 IU/mL and Target Not Detected (< LLOD) at Week 48
Time frame: Weeks 48
Percentage of Participants With Plasma HBV DNA < 20 IU/mL and Target Not Detected (< LLOD) at Week 96
Time frame: Weeks 96
Percentage of Participants With Serological Response: Loss of Hepatitis B s-Antigen (HBsAg) at Week 24
Time frame: Week 24
Percentage of Participants With Serological Response: Loss of HBsAg at Week 48
Time frame: Week 48
Percentage of Participants With Serological Response: Loss of HBsAg at Week 96
Time frame: Week 96
Percentage of Participants With Serological Response: Seroconversion to Anti-HBs at Week 24
Time frame: Week 24
Percentage of Participants With Serological Response: Seroconversion to Anti-HBs at Week 48
Time frame: Week 48
Percentage of Participants With Serological Response: Seroconversion to Anti-HBs at Week 96
Time frame: Week 96
Percentage of Participants With Serological Response: Loss of HBeAg in HBeAg-Positive Participants at Week 24
Time frame: Week 24
Percentage of Participants With Serological Response: Loss of HBeAg in HBeAg-Positive Participants at Week 48
Time frame: Week 48
Percentage of Participants With Serological Response: Loss of HBeAg in HBeAg-Positive Participants at Week 96
Time frame: Week 96
Percentage of Participants With Serological Response: Seroconversion to Anti-HBe in HBeAg-Positive Participants at Week 24
Time frame: Week 24
Percentage of Participants With Serological Response: Seroconversion to Anti-HBe in HBeAg-Positive Participants at Week 48
Time frame: Week 48
Percentage of Participants With Serological Response: Seroconversion to Anti-HBe in HBeAg-Positive Participants at Week 96
Time frame: Week 96
Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Week 24 by Central Laboratory and the American Association for the Study of Liver Diseases (AASLD) Criteria
Time frame: Week 24
Percentage of Participants With Normal ALT at Week 48 by Central Laboratory and the AASLD Criteria
Time frame: Week 48
Percentage of Participants With Normal ALT at Week 96 by Central Laboratory and the AASLD Criteria
Time frame: Week 96
Percentage of Participants With Normalized ALT at Week 24 by Central Laboratory and the AASLD Criteria
Time frame: Week 24
Percentage of Participants With Normalized ALT at Week 48 by Central Laboratory and the AASLD Criteria
Time frame: Week 48
Percentage of Participants With Normalized ALT at Week 96 by Central Laboratory and the AASLD Criteria
Time frame: Week 96
Change From Baseline in FibroTest® Score at Week 24
Time frame: Baseline, Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationLim YS, Lin CY, Heo J, Bae H, Chuang WL, Hui AJ, et al. Safety and Efficacy of Switching to Tenofovir Alafenamide in Virally Suppressed Chronic Hepatitis B Patients With Hepatic Impairment: Week-48 Results From a Phase 2 Open-label Study [Poster SAT442]. The Digital International Liver Congress (ILC); 2020 27-29 August.
- Results publicationJanssen HLA, Lampertico P, Chen CY, Heo J, Fournier C, Ahn SH, et al. Safety and Efficacy of Switching to Tenofovir Alafenamide in Virally Suppressed Chronic Hepatitis B Patients With Renal Impairment: Week-48 Results From a Phase 2 Open-label Study [Poster SAT429]. The Digital International Liver Congress (ILC); 2020 27-29 August.
- Results publicationLim YS, Lampertico P, Bae H, Chuang WL, Heo J, Huang YH, et al. Switching From Tenofovir Disoproxil Fumarate or Other Oral Antiviral Therapy to Tenofovir Alafenamide in Virally Suppressed Chronic Hepatitis B Patients With Hepatic Impairment: Week 24 Efficacy and Safety Results From a Phase 2 Open-label Study [Poster 501]. AASLD: The Liver Meeting; 2019 08-12 November; Boston, MA.
- Results publicationJanssen HLA, Lim YS, Gane EJ, Fournier C, Ahn SH, Tsang O, et al. Efficacy and Safety of Switching to Tenofovir Alafenamide in Virally Suppressed Chronic Hepatitis B Patients With Renal Impairment: Week 24 Results From a Phase 2 Open-label Study [Poster 483]. AASLD: The Liver Meeting; 2019 08-12 November; Boston, MA.
- Derived from this study: PubMed 40744841Liu CJ, Lim YS, Chen CY, Chen CH, Huang YH, Lin CY, Lin CC, Yu ML, Abramov F, Yee LJ, Duan R, Flaherty JF, Su WW, Yang SS, Janssen HLA, Chuang WL. Switching to tenofovir alafenamide in virally-suppressed chronic hepatitis B patients with renal/hepatic impairment: Phase 2 study sub-analysis from Taiwan. J Formos Med Assoc. 2025 Jul 30:S0929-6646(25)00390-0. doi: 10.1016/j.jfma.2025.07.023. Online ahead of print.
- Derived from this study: PubMed 38901444Janssen HLA, Lim YS, Lampertico P, Heo J, Chen CY, Fournier C, Tsang TYO, Bae H, Chen CH, Coffin CS, Ahn SH, Trinh H, Flaherty JF, Abramov F, Zhao Y, Liu Y, Lau A, German P, Chuang WL, Agarwal K, Gane E. Switching to tenofovir alafenamide in patients with virologically suppressed chronic hepatitis B and renal or hepatic impairment: final week 96 results from an open-label, multicentre, phase 2 study. Lancet Gastroenterol Hepatol. 2024 Aug;9(8):718-733. doi: 10.1016/S2468-1253(24)00096-7. Epub 2024 Jun 17.
- Individual participant dataSharing planned: Yes. Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilead Study Director study director
Gilead Sciences
30 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TAF in people with Chronic Hepatitis B, run by Gilead Sciences at 30 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in Taiwan, Canada, United States, South Korea, Hong Kong and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Achieving Virologic Response (Plasma Hepatitis B Virus [HBV] Deoxyribonucleic Acid [DNA] < 20 IU/mL) at Week 24 (time frame: Week 24). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03180619, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2021.