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Hepatitis BPhase 4NCT02849132

Effect of Entecavir Treatment on Regression and Disease Outcome in HBV-induced Liver Fibrosis and Cirrhosis Patients

A Phase 4 study testing Entecavir in people with Hepatitis B and Liver Cirrhosis, run by Beijing Friendship Hospital at 20 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Patients who have completed 2 years follow-up of the past National 12th Five-Year Major Project on Infectious Diseases will receive another 8 years treatment with entecavir (10 years in total). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Hepatitis B, Liver Cirrhosis
What is being tested?
Entecavir
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
800 participants
Where
20 sitesChina
Study dates
Jan 2016to Dec 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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects who completed the 2 years of entecavir-based therapy in Regress study; Subjects who are willing to participate the extension study.

Who cannot join

  • Any complication of severe heart, lung, kidney, brain, blood diseases or other important systematic diseases; Pregnant women; Subjects who could not compliance with the protocol judged by investigators; Subjects who are not suitable for the study judged by investigators.

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

China20 sites

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

  • 302 Military Hospital Of China

    Beijing, Beijing Municipality, 100039

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050

  • Beijing Tiantan Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100050

  • Beijing YouAn Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100069

  • NanfangHospital,Southern Medical University

    Guangzhou, Guangdong, 510515

  • Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

    Hangzhou, Zhejiang, 310016

  • Renji Hospital, Shanghai Jiao Tong University, School of Medicine

    Shanghai, Shanghai Municipality, 200032

  • Zhongshan Hospital Fudan University

    Shanghai, Shanghai Municipality, 200040

  • Shanghai General Hospital

    Shanghai, Shanghai Municipality, 200080

  • Shanghai Public Health Clinical Center

    Shanghai, Shanghai Municipality, 201508

  • The Third Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050051

  • Shijiazhuang Fifth Hospital

    Shijiazhuang, Hebei, 50021

  • The First Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 30001

  • Tianjin Xiqing Hospital

    Tianjin, Tianjin Municipality, 300380

  • Tianjin Third Central Hospital

    Tianjin, 300170

  • Tongji Hospital, Tongji Medical College , Huazhong University of Science and Technology

    Wuhan, Hubei, 430030

  • Xijing Hospital, Fourth Military Medical University

    Xi’an, Shanxi, 710032

  • The Affiliated Hospital of Yanbian University

    Yanji, Jilin, 133000

Other trials in China

About this study

Official title: Effect of Entecavir Treatment on Regression and Long-term Disease Outcome in Patients With HBV-induced Liver Fibrosis and Cirrhosis (Regress Extension Study)

Patients who have completed 2 years follow-up of the past National 12th Five-Year Major Project on Infectious Diseases will receive another 8 years treatment with entecavir (10 years in total). Collect serology, imaging, and other clinical data to evaluate the incidence and mortality of decompensated cirrhosis and hepatocellular carcinoma. Understand the effects of long-term antiviral therapy on HBV-induced liver fibrosis/cirrhosis.

Read the detailed description

Patients who have completed 2-years entecavir-based treatment in Regress Study will receive another 8 years of entecavir extension therapy. Patients will be assessed at baseline and every six months for blood cell count, liver function test, HBV-DNA, AFP, prothrombin time, liver ultrasonography, and Fibroscan; A third liver biopsy will be performed at the 5th year of treatment in patients who have significant fibrosis at second biopsy. CT /MRI and endoscopy will be performed at baseline and the 5th and 10th year of treatment.

Being tested
Entecavir
Medical subject headings
Hepatitis B, Liver Cirrhosis

What participants receive

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

  • EntecavirDrug

    oral entecavir 0.5mg daily for 8 years

Study groups in NCT02849132
Study groupRoleWhat they receive
Treatment groupExperimentalentecavir oral，0.5mg daily for 8 years
Receives: Drug: Entecavir

What is being measured

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

  1. Fibrosis regression rate

    Ishak fibrosis score decrease after long-term treatment

    Measured: year 3

  2. Cumulative incidence of liver decompensation

    Cumulative incidence of liver decompensation (including ascites, hepatic encephalopathy, esophageal varices bleeding and Hepatocellular Carcinoma) and death after long-term treatment

    Measured: year 8

Secondary outcomes (8)

  1. Virological response

    Percentage of patients achieving hepatitis B virus (HBV) DNA < 20IU/mL at year 3, 5, 7 and 10

    Measured: year 3, 5, 7 and 10

  2. Aminotransferase response

    The percentage of patients with alanine aminotransferase (ALT) normalization at year 3, 5, 7 and 10

    Measured: year 3, 5, 7 and 10

  3. HBeAg loss or HBeAg seroconversion

    Percentage of patients with HBeAg loss or HBeAg seroconversion at year 2, 5, 7 and 10

    Measured: year 2, 5, 7 and 10

  4. HBsAg loss or HBsAg seroconversion rate

    Percentage of patients with HBsAg loss or HBsAg seroconversion at year 2, 5, 7 and 10

    Measured: year 2, 5, 7 and 10

  5. Dynamic changes of Child-Pugh score

    Dynamic changes of Child-Pugh score after 3, 5, 7 and 10 years of treatment

    Measured: year 3, 5, 7 and 10

  6. Dynamic changes of MELD score

    Dynamic changes of MELD score after 3, 5, 7 and 10 years of treatment

    Measured: year 3, 5, 7 and 10

  7. Dynamic changes of liver stiffness values measured by Transient Elastography

    Dynamic changes of liver stiffness values after 3, 5, 7 and 10 years of treatment

    Measured: year 3, 5, 7 and 10

  8. Improvement of life quality (SF36 and EQ-5D)

    Improvement of life quality after 3, 5, 7 and 10 years of treatment

    Measured: year 3, 5, 7 and 10

Timeline

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

  1. First posted29 Jul 2016 (estimated)
  2. Study startJan 2016
  3. Primary completionDec 2023 (estimated)
  4. Study completionDec 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
Masking
None (open label)
Enrolment
800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02849132
Sponsor's protocol ID
2016ZX10002011
Status last verified
Apr 2021
First submitted
22 Jul 2016
Last updated
28 Apr 2021
Results posted
No

Publications

  • Arvaniti V, D'Amico G, Fede G, Manousou P, Tsochatzis E, Pleguezuelo M, Burroughs AK. Infections in patients with cirrhosis increase mortality four-fold and should be used in determining prognosis. Gastroenterology. 2010 Oct;139(4):1246-56, 1256.e1-5. doi: 10.1053/j.gastro.2010.06.019. Epub 2010 Jun 14.

    PubMed 20558165

  • Liaw YF, Sung JJ, Chow WC, Farrell G, Lee CZ, Yuen H, Tanwandee T, Tao QM, Shue K, Keene ON, Dixon JS, Gray DF, Sabbat J; Cirrhosis Asian Lamivudine Multicentre Study Group. Lamivudine for patients with chronic hepatitis B and advanced liver disease. N Engl J Med. 2004 Oct 7;351(15):1521-31. doi: 10.1056/NEJMoa033364.

    PubMed 15470215

  • Zhang J, Chen S, Zhou J, Wang B, Wu X, Xu X, Zhao X, Kong Y, Ou X, Sun Y, You H. Serial Liver Stiffness Measurement and Serum Biomarkers Are Not Strong Predictors of the Regression of Fibrosis among Chronic Hepatitis B Patients Receiving Antiviral Therapy Based on Triple Liver Biopsies. Gut Liver. 2025 Nov 15;19(6):889-899. doi: 10.5009/gnl250008.

    PubMed 41234032

  • Wu X, Hong J, Zhou J, Sun Y, Li L, Xie W, Piao H, Xu X, Jiang W, Feng B, Chen Y, Xu M, Cheng J, Meng T, Wang B, Chen S, Kong Y, Ou X, You H, Jia J. Health-related quality of life improves after entecavir treatment in patients with compensated HBV cirrhosis. Hepatol Int. 2021 Dec;15(6):1318-1327. doi: 10.1007/s12072-021-10240-4. Epub 2021 Nov 29.

    PubMed 34843068

  • Wu X, Zhou J, Sun Y, Ding H, Chen G, Xie W, Piao H, Xu X, Jiang W, Ma H, Ma A, Chen Y, Xu M, Cheng J, Xu Y, Meng T, Wang B, Chen S, Shi Y, Kong Y, Ou X, You H, Jia J. Prediction of liver-related events in patients with compensated HBV-induced cirrhosis receiving antiviral therapy. Hepatol Int. 2021 Feb;15(1):82-92. doi: 10.1007/s12072-020-10114-1. Epub 2021 Jan 18.

    PubMed 33460002

  • Yang JM, Chen LP, Wang YJ, Lyu B, Zhao H, Shang ZY, Li J, Fan ZY, Wu SD, Ming X, Li X, Huang SP, Cheng JL. Entecavir add-on Peg-interferon therapy plays a positive role in reversing hepatic fibrosis in treatment-naive chronic hepatitis B patients: a prospective and randomized controlled trial. Chin Med J (Engl). 2020 Jul 20;133(14):1639-1648. doi: 10.1097/CM9.0000000000000857.

    PubMed 32568867

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Entecavir in people with Hepatitis B and Liver Cirrhosis, run by Beijing Friendship Hospital at 20 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 1 inclusion and 1 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 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 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?

Fibrosis regression rate (time frame: year 3). 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 NCT02849132, 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 28 Apr 2021.

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