Chronic Hepatitis BPhase 2NCT02862548

Efficacy and Safety of Tenofovir Alafenamide (TAF) Versus Tenofovir Disoproxil Fumarate (TDF)-Containing Regimens in Participants With Chronic Hepatitis B Virus (HBV) Infection and Stage 2 or Greater Chronic Kidney Disease Who Have Received a Liver Transplant

A Phase 2 study testing TAF, TDF and Other approved antivirals in people with Chronic Hepatitis B, run by Gilead Sciences at 1 site in New Zealand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary objectives of this study are to evaluate the safety, tolerability, and efficacy of tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF)-containing regimens at Week 24 in participants with chronic hepatitis B virus (HBV) infection and Stage 2 or greater chronic kidney disease who have… 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, TDF and Other approved antivirals
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 51 participants
Where: 1 siteNew Zealand
Study dates: 16 Sep 2016to 5 May 2021
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

Must have the ability to understand and sign a written informed consent form; consent must be obtained prior to initiation of study procedures
Documented evidence of chronic HBV infection prior to transplantation
Primary or secondary (re-transplant), liver alone or liver and kidney transplant recipient from deceased or living donor
Liver Transplant ≥ 12 weeks prior to screening
Maintained on TDF alone or in combination with other approved antivirals for HBV prophylaxis or treatment
Have been on approved HBV oral antiviral (OAV) treatment for at least 12 weeks post-transplant prior to screening, with HBV DNA < lower limit of quantification (LLOQ) at screening

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Screening estimated glomerular filtration rate using the chronic kidney disease epidemiology collaboration (eGFR_CKD-EPI) < 90 ml/min/1.73m^2
Male participants and female participants of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
Women considered of child bearing potential must have a negative serum pregnancy test at Screening and a negative urine test at Baseline before dosing
Must be willing and able to comply with all study requirements

Who cannot join

Multi-organ transplant that includes heart or lung recipient (participants who have their liver transplant as part of a liver-kidney dual transplant are eligible to enroll)
Participants with history of de novo or recurrent hepatocellular carcinoma (HCC) post-transplant and at screening
Histological evidence of unresolved transplant rejection
Current, uncontrolled ascites, variceal hemorrhage, hepatic encephalopathy, hepatorenal syndrome, hepatopulmonary syndrome, or other signs of decompensated cirrhosis
Participants meeting any of the following laboratory parameters at screening:
Alanine aminotransferase (ALT) > 10 × the upper limit of normal (ULN)

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International normalized ratio (INR) > 1.5 × ULN unless the participant is stable on anticoagulant regimen affecting INR
Albumin < 3.0 g/dL
Direct bilirubin ≥ 4 × ULN
Platelet count < 50,000/mL
Co-infection with HIV or hepatitis C virus (HCV)
Recent (within 4 weeks of Screening) episode or infection requiring systemic antibiotics
Use of any prohibited medications listed within 28 days of the Baseline/Day 1 visit
Malignancy within 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (e.g., basal cell skin cancer, etc.) or hepatocellular carcinoma. Participants under evaluation for possible malignancy are not eligible
Significant cardiovascular, pulmonary, or neurological disease
Use of investigational agents within 3 months of screening, unless allowed by the Sponsor
Use of any prohibited medications
Current alcohol or substance abuse judged by the investigator to potentially interfere with participant compliance
Known hypersensitivity to study drugs, metabolites or formulation excipients
Lactating females or those who may wish to become pregnant during the course of the study
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Trial locations and contacts

1 site in 1 country.

New Zealand1 site

Auckland City Hospital
Auckland

Other trials in New Zealand

About this study

Official title: A Phase 2, Randomized, Open Label Study to Evaluate the Efficacy and Safety of Tenofovir Alafenamide (TAF) Versus Tenofovir Disoproxil Fumarate (TDF)-Containing Regimens in Subjects With Chronic HBV Infection and Stage 2 or Greater Chronic Kidney Disease Who Have Received a Liver Transplant

Conditions: Chronic Hepatitis B
Being tested: TAF, TDF, Other approved antivirals
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
TDFDrug
Tablet administered orally
Other approved antiviralsDrug
Other approved antivirals (such as lamivudine, entecavir, or immunoglobulin antihepatitis B) administered per local practice

Study groups in NCT02862548
Study group	Role	What they receive
TAF	Experimental	TAF 25 mg once daily for 48 weeks Receives: Drug: TAF
TDF-Containing Regimens	Active comparator	TDF alone or in combination with other approved antivirals per local practice for 48 weeks Receives: Drug: TDF; Drug: Other approved antivirals
Optional Treatment Extension Phase	Experimental	After Week 48, participants will be eligible to receive TAF 25 mg once daily for an additional 144 weeks. Receives: Drug: TAF

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Serum Estimated Glomerular Filtration Rate (eGFR) at Week 24 Using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Creatinine Equation
Measured: Baseline, Week 24
Percentage of Participants With HBV DNA < 20 IU/mL at Week 24
Measured: Week 24

Secondary outcomes (8)

Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 24
Measured: Baseline, Week 24
Percent Change From Baseline in Hip BMD at Week 48
Measured: Baseline, Week 48
Percent Change From Baseline in Spine BMD at Week 24
Measured: Baseline, Week 24
Percent Change From Baseline in Spine BMD at Week 48
Measured: Baseline, Week 48
Change From Baseline in Serum Creatinine at Week 24
Measured: Baseline, Week 24
Change From Baseline in Serum Creatinine at Week 48
Measured: Baseline, Week 48
Change From Baseline in Serum eGFR_CKD-EPI at Week 48
Measured: Baseline, Week 48
Percentage of Participants With HBV DNA < 20 IU/mL at Week 48
Measured: Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Sep 20165 May 2021

First posted11 Aug 2016 (estimated)
Study start16 Sep 2016
Primary completion8 Feb 2018
Study completion5 May 2021

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.
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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02862548
Sponsor's protocol ID: GS-US-320-3912
Other IDs: ACTRN12616000898459
Status last verified: Jun 2022
First submitted: 8 Aug 2016
Last updated: 8 Jun 2022
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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B

All Chronic Hepatitis B trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Randomized, Open Label Study to Evaluate the Efficacy and Safety of Tenofovir Alafenamide (TAF) Versus Tenofovir Disoproxil Fumarate (TDF)-Containing Regimens in Subjects With Chronic HBV Infection and Stage 2 or Greater Chronic Kidney Disease Who Have Received a Liver Transplant
ClinicalTrials.gov ID: NCT02862548
Acronym / sponsor ID: GS-US-320-3912
Conditions: Chronic Hepatitis B
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 51 participants (actual)
Lead sponsor: Gilead SciencesIndustry (pharma, biotech, devices)
Study start: 16 Sep 2016 (actual)
Primary completion: 8 Feb 2018 (actual)
Study completion: 5 May 2021 (actual)
First posted: 11 Aug 2016 (estimated)
Results: Posted 26 Feb 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
TAF	Experimental	Drug: TAFTAF 25 mg once daily for 48 weeks
TDF-Containing Regimens	Active comparator	Drug: TDF, Drug: Other approved antiviralsTDF alone or in combination with other approved antivirals per local practice for 48 weeks
Optional Treatment Extension Phase	Experimental	Drug: TAFAfter Week 48, participants will be eligible to receive TAF 25 mg once daily for an additional 144 weeks.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Must have the ability to understand and sign a written informed consent form; consent must be obtained prior to initiation of study procedures
Documented evidence of chronic HBV infection prior to transplantation
Primary or secondary (re-transplant), liver alone or liver and kidney transplant recipient from deceased or living donor
Liver Transplant ≥ 12 weeks prior to screening
Maintained on TDF alone or in combination with other approved antivirals for HBV prophylaxis or treatment

Key exclusion criteria (21 listed)

Multi-organ transplant that includes heart or lung recipient (participants who have their liver transplant as part of a liver-kidney dual transplant are eligible to enroll)
Participants with history of de novo or recurrent hepatocellular carcinoma (HCC) post-transplant and at screening
Histological evidence of unresolved transplant rejection
Current, uncontrolled ascites, variceal hemorrhage, hepatic encephalopathy, hepatorenal syndrome, hepatopulmonary syndrome, or other signs of decompensated cirrhosis
Participants meeting any of the following laboratory parameters at screening:

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	Drug	Optional Treatment Extension Phase, TAF
TDFTablet administered orally	Drug	TDF-Containing Regimens
Other approved antiviralsOther approved antivirals (such as lamivudine, entecavir, or immunoglobulin antihepatitis B) administered per local practice	Drug	TDF-Containing Regimens

Primary outcome

Change From Baseline in Serum Estimated Glomerular Filtration Rate (eGFR) at Week 24 Using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Creatinine Equation
Time frame: Baseline, Week 24
Percentage of Participants With HBV DNA < 20 IU/mL at Week 24
Time frame: Week 24

8 secondary outcomes

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 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
Change From Baseline in Serum Creatinine at Week 24
Time frame: Baseline, Week 24
Change From Baseline in Serum Creatinine at Week 48
Time frame: Baseline, Week 48
Change From Baseline in Serum eGFR_CKD-EPI at Week 48
Time frame: Baseline, Week 48
Percentage of Participants With HBV DNA < 20 IU/mL at Week 48
Time frame: Week 48

Results and safety

Results posted to the registry on 26 Feb 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TAF 25 mg	26	26
TDF-Containing Regimens	25	24

Primary outcome: Change From Baseline in Serum Estimated Glomerular Filtration Rate (eGFR) at Week 24 Using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Creatinine Equation

Time frame: Baseline, Week 24. Mean (Standard Deviation). Unit: mL/min/1.73 m^2

Measure	TAF 25 mg n = 26	TDF-Containing Regimens n = 25
Value	2.13 (6.011)	1.87 (6.553)

Population analysed: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.

Primary outcome: Percentage of Participants With HBV DNA < 20 IU/mL at Week 24

Time frame: Week 24. Number. Unit: percentage of participants

Measure	TAF 25 mg n = 26	TDF-Containing Regimens n = 25
Value	100.0	100.0

Population analysed: Full Analysis Set included all randomized participants who have received at least 1 dose of study drug. The missing = failure approach was used.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Randomized Phase: TAF 25 mg	3 of 26 (11.5%)	19 of 26 (73.1%)	0 of 26
Randomized Phase: TDF-Containing Regimens	7 of 25 (28%)	17 of 25 (68%)	1 of 25
OLE Phase: TAF 25 mg From TAF	8 of 26 (30.8%)	22 of 26 (84.6%)	2 of 26
OLE Phase: TAF 25 mg From TDF	8 of 24 (33.3%)	21 of 24 (87.5%)	0 of 24

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.

Related trials for Chronic Hepatitis B

Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TAF, TDF and Other approved antivirals in people with Chronic Hepatitis B, run by Gilead Sciences at 1 site in New Zealand.

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 10 inclusion and 21 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 8 Jun 2022. 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 New Zealand. 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 26 Feb 2019). 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?

Change From Baseline in Serum Estimated Glomerular Filtration Rate (eGFR) at Week 24 Using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Creatinine Equation (time frame: Baseline, Week 24). The study lists 2 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 NCT02862548.

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 8 Jun 2022.