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Chronic Hepatitis BPhase 4NCT04939441

Regression of Liver Fibrosis by Tenofovir Alafenamide (TAF)

A Phase 4 study testing Tenofovir alafenamide in people with Chronic Hepatitis B, run by Jidong Jia at 7 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Tenofovir alafenamide (TAF) is a new prodrug of tenofovir developed to treat patients with chronic hepatitis B virus (HBV) infection. Whereas, the long-term effect of TAF to liver fibrosis is still unknown. Read more about this study

Who is it for?
Ages 18 to 69 years
Conditions the study is for
Chronic Hepatitis B
What is being tested?
Tenofovir alafenamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
7 sitesChina
Study dates
20 Apr 2021to 1 May 2025
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 18 to 69 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18-69 years old (inclusive);
  • BMI (18-30 kg/m2);
  • Chronic hepatitis B virus (HBV) infection, defined as positive serum hepatitis B s-antigen (HBsAg) for more than 6 months; or chronic hepatitis B proven by live biopsy;
  • Not received nucleoside (acid) analogue and/or interferon therapy (treatment-naive);
  • Liver biopsy performed within 6 months before treatment and had readable biopsy slides or agrees to have a biopsy performed prior to baseline;
  • METAVIR fibrosis stage ≥ F2;
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  • For patients without cirrhosis (F2/3), HBV DNA levels >2000 IU/mL before treatment; For patients with cirrhosis (F4), HBV DNA >20 IU/mL before treatment;
  • ALT≤10 ULN before treatment;
  • Creatinine clearance ≥ 50 mL/min;
  • Agreement not to undertake other HBV systemic antiviral or interferon (IFN) regimens during participation in this study;
  • Willing and able to provide written informed consent.

Who cannot join

  • Patients with Child-Turcotte-Pugh（CTP）score ≥ 7;
  • Patients with decompensated cirrhosis: including ascites, hepatic encephalopathy, esophageal varices bleeding or other complications of decompensated cirrhosis or liver transplantation;
  • Patients co-infection with hepatitis C virus (HCV), human immunodeficiency virus (HIV), or hepatitis delta virus (HDV), or alcoholic liver diseases, autoimmune liver disease, genetic liver disease, drug-induced liver injury, non-alcoholic fatty liver disease or other chronic liver diseases;
  • Patients with evidence of hepatocellular carcinoma (HCC) by imaging with or without AFP;
  • Patients with other uncured malignant tumors;
  • Patients with organ or bone marrow transplantation;
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  • Patients currently receiving therapy with immunomodulators (eg, corticosteroids, etc.), investigational agents, nephrotoxic agents, or agents susceptible of modifying renal excretion;
  • Patients who are allergic to any component of TAF;
  • Patients who recently or newly started bisphosphate (within 1 month);
  • Patients with active alcohol or drug abuse or history of alcohol or drug abuse (hinder compliance with treatment, or participation in the study or interpretation of results considered by the Investigator);
  • Patients with significant renal, cardiovascular, pulmonary, or neurological disease
  • Males and females of reproductive potential who are unwilling to use an effective method of contraception during the study;
  • Pregnant women, women who are breast feeding or who believe they may wish to become pregnant during the course of the study;
  • Not suitable for this study identified by researchers.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

China7 sites

  • Beijing Ditan Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100015

  • Shuguang Hospital

    Shanghai, Shanghai Municipality, 200021

  • Huashan Hospital Fudan University

    Shanghai, Shanghai Municipality, 200040

  • Ruijin Hospital

    Shanghai, Shanghai Municipality, 201199

  • Shanghai East Hospital

    Shanghai, Shanghai Municipality, 310000

  • Tianjin Third Central Hospital

    Tianjin, Tianjin Municipality, 300170

  • Tianjin Second People's Hospital

    Tianjin, Tianjin Municipality, 300192

Other trials in China

About this study

Official title: Regression of Liver Fibrosis by Tenofovir Alafenamide (TAF) in Treatment-Naive CHB Related Fibrosis/Cirrhosis: a 96w Open-label Multicenter Study

Tenofovir alafenamide (TAF) is a new prodrug of tenofovir developed to treat patients with chronic hepatitis B virus (HBV) infection. Whereas, the long-term effect of TAF to liver fibrosis is still unknown. Here, we enrolled treatment naive CHB patients with biopsy-proven significant fibrosis (METAVIR fibrosis stage ≥ F2). All enrolled subjects will be treated with TAF monotherapy for 96 weeks. After 96 weeks of therapy, the second liver biopsy will be performed to evaluate the rate of liver fibrosis regression. During this study, all subjects will be assessed for laboratory tests, imaging examination at baseline, first 12-week and every 24-week during follow-up.

Being tested
Tenofovir alafenamide
Keywords
Chronic Hepatitis B, Liver fibrosis, Liver cirrhosis, Tenofovir alafenamide
Medical subject headings
Hepatitis B, Chronic, Liver Cirrhosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tenofovir alafenamideDrug

    Also called Vemlidy®

    Subjects will be treated for 96 weeks with TAF [Vemlidy® 25mg QD] monotherapy

Study groups in NCT04939441
Study groupRoleWhat they receive
TAF groupExperimentalTAF [Vemlidy® 25mg QD] monotherapy
Receives: Drug: Tenofovir alafenamide

What is being measured

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

  1. Proportion of patients with fibrosis regression

    Fibrosis stage decrease at least 1 point by Ishak score or "Predominantly Regressive" by "Beijing classification"

    Measured: Week 96

  2. HBV DNA undetectable rate

    Serum HBV DNA <20 IU/mL

    Measured: Week 96

Secondary outcomes (7)

  1. Percentage of liver stiffness decrease >= 30%

    Proportion of patients with liver stiffness decrease >= 30% from baseline to week 48 and 96

    Measured: Week 48 and Week 96

  2. HBV DNA undetectable rate

    HBV DNA undetectable rate at week 24, 48, and 72

    Measured: Week 24, Week 48 and Week 72

  3. ALT normalization rate

    Proportion of patients with ALT <= 1.0xULN

    Measured: Week 48 and Week 96

  4. HBeAg and HBsAg loss and seroconversion rate

    Proportions of patients with HBsAg loss and seroconversion to anti-HBs, and proportions of patients with HBeAg loss and seroconversion to anti-HBe.

    Measured: Week 48 and Week 96

  5. Changes in renal function

    Changes of eGFR (estimated Glomerular Filtration rate) from baseline to week 48 and 96

    Measured: Week 48 and Week 96

  6. Changes of bone mineral density

    Percentage changes in spine BMD and hip BMD from baseline to week 48 and 96

    Measured: Week 48 and Week 96

  7. Incidence of liver-related endpoint events

    liver-related endpoint events: decompensation, HCC, liver transplantation, liver-related death

    Measured: Week 96

Timeline

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

  1. First posted25 Jun 2021
  2. Study start20 Apr 2021
  3. Primary completion1 May 2024 (estimated)
  4. Study completion1 May 2025 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Model description
Subjects will be treated for 96 weeks with TAF \[Vemlidy® 25mg QD\] monotherapy
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04939441
Sponsor's protocol ID
IN-CN-320-5613
Status last verified
May 2023
First submitted
17 Jun 2021
Last updated
23 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Chan HL, Fung S, Seto WK, Chuang WL, Chen CY, Kim HJ, Hui AJ, Janssen HL, Chowdhury A, Tsang TY, Mehta R, Gane E, Flaherty JF, Massetto B, Gaggar A, Kitrinos KM, Lin L, Subramanian GM, McHutchison JG, Lim YS, Acharya SK, Agarwal K; GS-US-320-0110 Investigators. Tenofovir alafenamide versus tenofovir disoproxil fumarate for the treatment of HBeAg-positive chronic hepatitis B virus infection: a randomised, double-blind, phase 3, non-inferiority trial. Lancet Gastroenterol Hepatol. 2016 Nov;1(3):185-195. doi: 10.1016/S2468-1253(16)30024-3. Epub 2016 Sep 22.

    PubMed 28404091

  • Buti M, Gane E, Seto WK, Chan HL, Chuang WL, Stepanova T, Hui AJ, Lim YS, Mehta R, Janssen HL, Acharya SK, Flaherty JF, Massetto B, Cathcart AL, Kim K, Gaggar A, Subramanian GM, McHutchison JG, Pan CQ, Brunetto M, Izumi N, Marcellin P; GS-US-320-0108 Investigators. Tenofovir alafenamide versus tenofovir disoproxil fumarate for the treatment of patients with HBeAg-negative chronic hepatitis B virus infection: a randomised, double-blind, phase 3, non-inferiority trial. Lancet Gastroenterol Hepatol. 2016 Nov;1(3):196-206. doi: 10.1016/S2468-1253(16)30107-8. Epub 2016 Sep 22.

    PubMed 28404092

  • Agarwal K, Brunetto M, Seto WK, Lim YS, Fung S, Marcellin P, Ahn SH, Izumi N, Chuang WL, Bae H, Sharma M, Janssen HLA, Pan CQ, Celen MK, Furusyo N, Shalimar D, Yoon KT, Trinh H, Flaherty JF, Gaggar A, Lau AH, Cathcart AL, Lin L, Bhardwaj N, Suri V, Mani Subramanian G, Gane EJ, Buti M, Chan HLY; GS-US-320-0110; GS-US-320-0108 Investigators. 96 weeks treatment of tenofovir alafenamide vs. tenofovir disoproxil fumarate for hepatitis B virus infection. J Hepatol. 2018 Apr;68(4):672-681. doi: 10.1016/j.jhep.2017.11.039. Epub 2018 Jan 17.

    PubMed 29756595

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tenofovir alafenamide in people with Chronic Hepatitis B, run by Jidong Jia at 7 sites in China.

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 14 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 23 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in China. 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?

Proportion of patients with fibrosis regression (time frame: Week 96). 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 NCT04939441, which also lists 3 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 23 May 2023.

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