Chronic Hepatitis BPhase 4DUALNCT02774837
Tenofovir Versus Tenofovir + Telbivudine for Chronic Hepatitis B
A Phase 4 study testing Tenofovir disoproxil and Telbivudine in people with Chronic Hepatitis B, run by Seng Gee Lim at 1 site in Singapore.
Trial summary
Chronic Hepatitis B is the most common cause of chronic viral liver disease worldwide afflicting 350 million persons, leading to significant morbidity and mortality due to liver disease and HCC in 20-40% of infected persons. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- Tenofovir disoproxil and Telbivudine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteSingapore
- Study dates
- Apr 2016to Jul 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of positive HBsAg or HBV DNA for at least 6 months.
- Documented HBeAg positive or HBeAg negative.
- On any NA (lamivudine, adefovir, entecavir, tenofovir or combination of any of these four) for ≥ 1 year
- HBV DNA viral load ≤1.0 x 10^5 copies/ml at screening
- ALT ≤ 1 x ULN (upper limit normal) U/L
- A transient elastography (Fibroscan®) to evaluate the fibrosis stage will be performed at screening if it is not done in the past 6 months prior to screening. -Patient with compensated cirrhosis are permitted for this study.
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- eGFR ≥ 50 mL/min, as calculated by CKI-EPI equation.
- Patient has agreed not to take any other investigational drug or systemic anti-viral, cytotoxic, corticosteroid, immunomodulatory agents or Chinese traditional remedies unless clinically indicated.
- Patient is able to give written consent prior to study start and to comply with the study requirements.
- Women of childbearing potential age must have a negative serum (ß-HCG) pregnancy test taken within 14 days of starting therapy
- Lactating/breastfeeding female subjects must agree to discontinue nursing before initiation of study medication(s).
Who cannot join
- Evidence of decompensated liver disease defined as direct (conjugated) bilirubin >1.2xULN, prothrombin time (PT) >1.5x upper limit of normal (ULN), serum albumin <35 g/L, or prior history of clinical hepatic decompensation (egs. ascites, encephalopathy, variceal hemorrhage).
- Evidence of hepatocellular carcinoma (HCC).
- Have any of the following laboratory tests within 4 weeks of study entry:
- Active co-infection with HIV antibody or HCV antibody or HDV antibody positivity
- Evidence of chronic renal insufficiency as defined by an eGFR (by CKD-EPI equation of < 50 mL/min).
- Previous treatment with any form of interferon, Immunomodulators, systemic cytotoxic agents, or systemic corticosteroids within 6 months prior to screening.
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- Prolonged exposure to known hepatotoxins such as alcohol or drugs.
- History of clinically relevant psychiatric disease, seizures, central nervous system dysfunction, severe pre-existing cardiac, renal, hematological disease or medical illness that in the investigator's opinion might interfere with therapy.
- Current or known history of malignant disease within 5 years of trial entry.
- Patients with a history of or currently known muscle related disease.
- Liver or any other organ transplant other than cornea and hair.
- Women who are pregnant and who are not practicing adequate birth control measures, or who are lactating.
- Patients with specific contraindications to study drugs according to their Singapore Package Insert.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Label Study of Nucleus(t)Ide Treated Patients Randomised to Tenofovir, or Tenofovir + Telbivudine
Chronic Hepatitis B is the most common cause of chronic viral liver disease worldwide afflicting 350 million persons, leading to significant morbidity and mortality due to liver disease and HCC in 20-40% of infected persons. With the advent of nucleoside analogues, this rescued patients with significant risk of disease progression, but in most circumstances, therapy was needed long term as HBsAg seroclearance was an uncommon occurrence, and stopping therapy was associated with relapse of disease and hepatitis B flares. The use of pegylated interferons showed increased HBeAg seroconversion and HBsAg seroclearance rates compared to nucleoside analogues , however combination nucleos(t)ide analogue therapy has been quite disappointing. However a recent showed that the combination of telbivudine and tenofovir in a response guided therapy design, had a remarkable 6% HBsAg seroclearance at week 52 in patients. Such results require further confirmation. There is currently an unmet need for the large number of patients on long term nucleoside analogue therapy who have not achieved HBeAg seroconversion or HBsAg seroclearance. Such patients are seeking alternatives to long term therapy hence an exploration of other therapeutic strategies is attractive. An additional benefit of telbivudine has been the surprising improvement in renal function and this study seeks to examine whether this can improve the renal impairment that may be seen with tenofovir. Our study proposes to examine if the combination of tenofovir and telbivudine can improve endpoints. Patients fulfilling inclusion and exclusion criteria will be randomized to tenofovir or tenofovir and telbivudine (1:1 ratio). The primary endpoint will be a qHBsAg reduction of >1log at week 96, which may predict future HBsAg seroclearance, which is also a secondary endpoint. An additional primary endpoint is increase in eGFR in the combination arm compared to the monotherapy arm. The study aims to enroll 146 patients randomized 1:1 ratio (73:73) patients. Multivariate analysis will be performed of baseline and on-treatment factors that predict the primary outcome.
Read the detailed description
Each subject must sign and date a study-specific informed consent form (ICF) prior to their participation in any screening activities. Prospective subjects should be screened no more than 28 days prior to administration of the first dose of study drug on Day 1. Screening evaluations will be used to determine eligibility of each candidate for study enrollment. Subjects meeting all of the inclusion criteria and none of the exclusion criteria as determined during screening will be eligible for the study. Candidates who fail to meet eligibility criteria by screening evaluations may be re-screened one time. Eligible patients at the end of screening will be randomised in a 1:1 ratio to experimental (combination) arm versus control (mono therapy) arm.
Randomisation will be performed by computer generated random codes (performed by Singapore Clinical Research Institute) with a masked allocation sequence. There will be no blinding of therapy and the study will be conducted as an open label study since the outcomes are objectively measurable.
After randomisation patients will be monitored 12 weekly for the first 24 weeks, then every 24 weekly until the last visit at 96 weeks.
At each visit, patients will have a clinical evaluation and have a panel of laboratory tests:
- Hematology: Full blood count, prothrombin time and international normalized ratio
- Chemistry: Sodium, potassium, creatinine, albumin, alkaline phosphatase, -aspartate transaminase, alanine transaminase, lactate dehydrogenase, total bilirubin, creatine phosphokinase, alphafetoprotein,
- Urinalysis: Urine dipstick (Appearance, color, leucocytes, nitrite, urobilinogen, protein, PH, specific gravity, ketone, bilirubin and glucose).
- Viral serology: HBeAg, anti-HBe, HBsAg, qHBsAg and anti-HBs
- Conditions
- Chronic Hepatitis B
- Being tested
- Tenofovir disoproxil, Telbivudine
- Keywords
- nucleoside analogues, tenofovir, telbivudine, quantitative HBsAg, combination therapy
- 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.
Tenofovir disoproxilDrug
Also called Viread
Tenofovir disoproxil 300mg once daily for 96 weeks
TelbivudineDrug
Also called Sebivo
Telbivudine oral tablets 600mg once daily for 96 weeks
| Study group | Role | What they receive |
|---|---|---|
| combination | Experimental | Tenofovir disoproxil oral tablets 300mg once daily for 96 weeks and Telbivudine 600mg oral tablets once daily for 96 weeks Receives: Drug: Tenofovir disoproxil; Drug: Telbivudine |
| mono therapy | Active comparator | Tenofovir disoproxil oral tablets 300mg once daily for 96 weeks Receives: Drug: Tenofovir disoproxil |
What is being measured
The primary outcome is the main question the study is designed to answer.
quantitative HBsAg (qHBsAg) reduction >1 log IU/ml
Proportion of patients who have a reduction of qHBsAg >1 log IU/ml from baseline to week 96, in experimental arm versus control arm
Measured: Baseline to week 96
Secondary outcomes (6)
HBsAg loss
Proportion of patients who achieve HBsAg loss at week 96 in experimental versus control arms
Measured: Baseline to week 96
HBsAg seroconversion
Proportion of patients who achieve HBsAg seroconversion at week 96 in experimental versus control arms
Measured: Baseline to week 96
HBeAg loss
Proportion of patients who achieve HBeAg loss at week 96 in experimental versus control arms
Measured: Baseline to week 96
HBeAg seroconversion
Proportion of patients who achieve HBeAg seroconversion at week 96 in experimental versus control arms
Measured: Baseline to week 96
quantitative HBsAg decline by >0.5 log10 IU/mL
Proportion of patients who have a reduction of qHBsAg >0.5 log IU/ml from baseline to week 96, in experimental arm versus control arm
Measured: Baseline, week 24, 48 and 96
Alteration in eGFR
Proportion of patients who have an increase in eGFR from baseline to week 96, in experimental arm versus control arm
Measured: Baseline to week 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2016 (estimated)
- Study startApr 2016
- Primary completionJul 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two arm parallel study
- Masking
- None (open label)
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seng Gee Lim
- Sponsor type
- University, hospital or other
- Collaborators
- National Medical Research Council (NMRC), Singapore, Singapore Clinical Research Institute
- Responsible party
- Sponsor-investigator, Seng Gee Lim, National University Health System, Singapore
- Investigators
- Seng Gee Lim, MBBS, FRACP, FRCP, MD, FAMS, Principal investigator, National University Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02774837
- Sponsor's protocol ID
- 2013/00215
- Acronym
- DUAL
- Status last verified
- Mar 2019
- First submitted
- 12 May 2016
- Last updated
- 18 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
European Association For The Study Of The Liver. EASL clinical practice guidelines: Management of chronic hepatitis B virus infection. J Hepatol. 2012 Jul;57(1):167-85. doi: 10.1016/j.jhep.2012.02.010. Epub 2012 Mar 20. No abstract available.
PubMed 22436845Piratvisuth T, Komolmit P, Tanwandee T, Sukeepaisarnjaroen W, Chan HL, Pessoa MG, Fassio E, Ono SK, Bessone F, Daruich J, Zeuzem S, Cheinquer H, Pathan R, Dong Y, Trylesinski A. 52-week efficacy and safety of telbivudine with conditional tenofovir intensification at week 24 in HBeAg-positive chronic hepatitis B. PLoS One. 2013;8(2):e54279. doi: 10.1371/journal.pone.0054279. Epub 2013 Feb 4.
PubMed 23390496Liaw YF. Clinical utility of hepatitis B surface antigen quantitation in patients with chronic hepatitis B: a review. Hepatology. 2011 Aug;54(2):E1-9. doi: 10.1002/hep.24473.
PubMed 21793018Chan HL, Thompson A, Martinot-Peignoux M, Piratvisuth T, Cornberg M, Brunetto MR, Tillmann HL, Kao JH, Jia JD, Wedemeyer H, Locarnini S, Janssen HL, Marcellin P. Hepatitis B surface antigen quantification: why and how to use it in 2011 - a core group report. J Hepatol. 2011 Nov;55(5):1121-31. doi: 10.1016/j.jhep.2011.06.006. Epub 2011 Jun 28.
PubMed 21718667Wursthorn K, Jung M, Riva A, Goodman ZD, Lopez P, Bao W, Manns MP, Wedemeyer H, Naoumov NV. Kinetics of hepatitis B surface antigen decline during 3 years of telbivudine treatment in hepatitis B e antigen-positive patients. Hepatology. 2010 Nov;52(5):1611-20. doi: 10.1002/hep.23905.
PubMed 20931556Gane EJ, Deray G, Liaw YF, Lim SG, Lai CL, Rasenack J, Wang Y, Papatheodoridis G, Di Bisceglie A, Buti M, Samuel D, Uddin A, Bosset S, Trylesinski A. Telbivudine improves renal function in patients with chronic hepatitis B. Gastroenterology. 2014 Jan;146(1):138-146.e5. doi: 10.1053/j.gastro.2013.09.031. Epub 2013 Sep 22.
PubMed 24067879Gara N, Zhao X, Collins MT, Chong WH, Kleiner DE, Jake Liang T, Ghany MG, Hoofnagle JH. Renal tubular dysfunction during long-term adefovir or tenofovir therapy in chronic hepatitis B. Aliment Pharmacol Ther. 2012 Jun;35(11):1317-25. doi: 10.1111/j.1365-2036.2012.05093.x. Epub 2012 Apr 16.
PubMed 22506503
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Study of Nucleus(t)Ide Treated Patients Randomised to Tenofovir, or Tenofovir + Telbivudine
- ClinicalTrials.gov ID
- NCT02774837
- Acronym / sponsor ID
- DUAL / 2013/00215
- Conditions
- Chronic Hepatitis B
- Keywords
- nucleoside analogues, tenofovir, telbivudine, quantitative HBsAg, combination therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Seng Gee LimUniversity, hospital or other
- Collaborators
- National Medical Research Council (NMRC), Singapore, Singapore Clinical Research Institute
- Study start
- Apr 2016 (actual)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 17 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic Hepatitis B is the most common cause of chronic viral liver disease worldwide afflicting 350 million persons, leading to significant morbidity and mortality due to liver disease and HCC in 20-40% of infected persons. With the advent of nucleoside analogues, this rescued patients with significant risk of disease progression, but in most circumstances, therapy was needed long term as HBsAg seroclearance was an uncommon occurrence, and stopping therapy was associated with relapse of disease and hepatitis B flares. The use of pegylated interferons showed increased HBeAg seroconversion and HBsAg seroclearance rates compared to nucleoside analogues , however combination nucleos(t)ide analogue therapy has been quite disappointing. However a recent showed that the combination of telbivudine and tenofovir in a response guided therapy design, had a remarkable 6% HBsAg seroclearance at week 52 in patients. Such results require further confirmation. There is currently an unmet need for the large number of patients on long term nucleoside analogue therapy who have not achieved HBeAg seroconversion or HBsAg seroclearance. Such patients are seeking alternatives to long term therapy hence an exploration of other therapeutic strategies is attractive. An additional benefit of telbivudine has been the surprising improvement in renal function and this study seeks to examine whether this can improve the renal impairment that may be seen with tenofovir. Our study proposes to examine if the combination of tenofovir and telbivudine can improve endpoints. Patients fulfilling inclusion and exclusion criteria will be randomized to tenofovir or tenofovir and telbivudine (1:1 ratio). The primary endpoint will be a qHBsAg reduction of >1log at week 96, which may predict future HBsAg seroclearance, which is also a secondary endpoint. An additional primary endpoint is increase in eGFR in the combination arm compared to the monotherapy arm. The study aims to enroll 146 patients randomized 1:1 ratio (73:73) patients. Multivariate analysis will be performed of baseline and on-treatment factors that predict the primary outcome.
Detailed description
Each subject must sign and date a study-specific informed consent form (ICF) prior to their participation in any screening activities. Prospective subjects should be screened no more than 28 days prior to administration of the first dose of study drug on Day 1. Screening evaluations will be used to determine eligibility of each candidate for study enrollment. Subjects meeting all of the inclusion criteria and none of the exclusion criteria as determined during screening will be eligible for the study. Candidates who fail to meet eligibility criteria by screening evaluations may be re-screened one time. Eligible patients at the end of screening will be randomised in a 1:1 ratio to experimental (combination) arm versus control (mono therapy) arm.
Randomisation will be performed by computer generated random codes (performed by Singapore Clinical Research Institute) with a masked allocation sequence. There will be no blinding of therapy and the study will be conducted as an open label study since the outcomes are objectively measurable.
After randomisation patients will be monitored 12 weekly for the first 24 weeks, then every 24 weekly until the last visit at 96 weeks.
At each visit, patients will have a clinical evaluation and have a panel of laboratory tests:
- Hematology: Full blood count, prothrombin time and international normalized ratio
- Chemistry: Sodium, potassium, creatinine, albumin, alkaline phosphatase, -aspartate transaminase, alanine transaminase, lactate dehydrogenase, total bilirubin, creatine phosphokinase, alphafetoprotein,
- Urinalysis: Urine dipstick (Appearance, color, leucocytes, nitrite, urobilinogen, protein, PH, specific gravity, ketone, bilirubin and glucose).
- Viral serology: HBeAg, anti-HBe, HBsAg, qHBsAg and anti-HBs
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two arm parallel study
| Arm | Type | Receives |
|---|---|---|
| combination | Experimental | Drug: Tenofovir disoproxil, Drug: TelbivudineTenofovir disoproxil oral tablets 300mg once daily for 96 weeks and Telbivudine 600mg oral tablets once daily for 96 weeks |
| mono therapy | Active comparator | Drug: Tenofovir disoproxilTenofovir disoproxil oral tablets 300mg once daily for 96 weeks |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Presence of positive HBsAg or HBV DNA for at least 6 months.
- Documented HBeAg positive or HBeAg negative.
- On any NA (lamivudine, adefovir, entecavir, tenofovir or combination of any of these four) for ≥ 1 year
- HBV DNA viral load ≤1.0 x 10^5 copies/ml at screening
- ALT ≤ 1 x ULN (upper limit normal) U/L
Key exclusion criteria (13 listed)
- Evidence of decompensated liver disease defined as direct (conjugated) bilirubin >1.2xULN, prothrombin time (PT) >1.5x upper limit of normal (ULN), serum albumin <35 g/L, or prior history of clinical hepatic decompensation (egs. ascites, encephalopathy, variceal hemorrhage).
- Evidence of hepatocellular carcinoma (HCC).
- Have any of the following laboratory tests within 4 weeks of study entry:
- Previous treatment with any form of interferon, Immunomodulators, systemic cytotoxic agents, or systemic corticosteroids within 6 months prior to screening.
- Prolonged exposure to known hepatotoxins such as alcohol or drugs.
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 |
|---|---|---|
| Tenofovir disoproxilAlso: VireadTenofovir disoproxil 300mg once daily for 96 weeks | Drug | combination, mono therapy |
| TelbivudineAlso: SebivoTelbivudine oral tablets 600mg once daily for 96 weeks | Drug | combination |
Primary outcome
quantitative HBsAg (qHBsAg) reduction >1 log IU/ml
Time frame: Baseline to week 96
Proportion of patients who have a reduction of qHBsAg >1 log IU/ml from baseline to week 96, in experimental arm versus control arm
6 secondary outcomes
HBsAg loss
Time frame: Baseline to week 96
HBsAg seroconversion
Time frame: Baseline to week 96
HBeAg loss
Time frame: Baseline to week 96
HBeAg seroconversion
Time frame: Baseline to week 96
quantitative HBsAg decline by >0.5 log10 IU/mL
Time frame: Baseline, week 24, 48 and 96
Alteration in eGFR
Time frame: Baseline to week 96
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2019.
- Background: PubMed 22436845European Association For The Study Of The Liver. EASL clinical practice guidelines: Management of chronic hepatitis B virus infection. J Hepatol. 2012 Jul;57(1):167-85. doi: 10.1016/j.jhep.2012.02.010. Epub 2012 Mar 20. No abstract available.
- Background: PubMed 23390496Piratvisuth T, Komolmit P, Tanwandee T, Sukeepaisarnjaroen W, Chan HL, Pessoa MG, Fassio E, Ono SK, Bessone F, Daruich J, Zeuzem S, Cheinquer H, Pathan R, Dong Y, Trylesinski A. 52-week efficacy and safety of telbivudine with conditional tenofovir intensification at week 24 in HBeAg-positive chronic hepatitis B. PLoS One. 2013;8(2):e54279. doi: 10.1371/journal.pone.0054279. Epub 2013 Feb 4.
- Background: PubMed 21793018Liaw YF. Clinical utility of hepatitis B surface antigen quantitation in patients with chronic hepatitis B: a review. Hepatology. 2011 Aug;54(2):E1-9. doi: 10.1002/hep.24473.
- Background: PubMed 21718667Chan HL, Thompson A, Martinot-Peignoux M, Piratvisuth T, Cornberg M, Brunetto MR, Tillmann HL, Kao JH, Jia JD, Wedemeyer H, Locarnini S, Janssen HL, Marcellin P. Hepatitis B surface antigen quantification: why and how to use it in 2011 - a core group report. J Hepatol. 2011 Nov;55(5):1121-31. doi: 10.1016/j.jhep.2011.06.006. Epub 2011 Jun 28.
- Background: PubMed 20931556Wursthorn K, Jung M, Riva A, Goodman ZD, Lopez P, Bao W, Manns MP, Wedemeyer H, Naoumov NV. Kinetics of hepatitis B surface antigen decline during 3 years of telbivudine treatment in hepatitis B e antigen-positive patients. Hepatology. 2010 Nov;52(5):1611-20. doi: 10.1002/hep.23905.
- Background: PubMed 24067879Gane EJ, Deray G, Liaw YF, Lim SG, Lai CL, Rasenack J, Wang Y, Papatheodoridis G, Di Bisceglie A, Buti M, Samuel D, Uddin A, Bosset S, Trylesinski A. Telbivudine improves renal function in patients with chronic hepatitis B. Gastroenterology. 2014 Jan;146(1):138-146.e5. doi: 10.1053/j.gastro.2013.09.031. Epub 2013 Sep 22.
- Background: PubMed 22506503Gara N, Zhao X, Collins MT, Chong WH, Kleiner DE, Jake Liang T, Ghany MG, Hoofnagle JH. Renal tubular dysfunction during long-term adefovir or tenofovir therapy in chronic hepatitis B. Aliment Pharmacol Ther. 2012 Jun;35(11):1317-25. doi: 10.1111/j.1365-2036.2012.05093.x. Epub 2012 Apr 16.
- Individual participant dataSharing planned: Undecided
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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.
Seng Gee Lim, MBBS, FRACP, FRCP, MD, FAMS principal investigator
National University Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tenofovir disoproxil and Telbivudine in people with Chronic Hepatitis B, run by Seng Gee Lim at 1 site in Singapore.
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 11 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 18 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
quantitative HBsAg (qHBsAg) reduction >1 log IU/ml (time frame: Baseline to week 96). 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 NCT02774837, which also lists 7 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 18 Mar 2019.