Liver CirrhosisPhase 4NCT01938820
Optimized Treatment and Regression of HBV-induced Early Cirrhosis
A Phase 4 study testing entecavir and Thymosin-α in people with Liver Cirrhosis, run by Beijing Friendship Hospital at 21 sites in China.
Trial summary
Patients with chronic hepatitis B histologically confirmed of early cirrhosis S4 (similar to metavir F4, Ishak 5/6) are randomly assigned in a 1:1 ratio. One arm is entecavir alone for 2 years; the other is entecavir for the first 0.5 year, entecavir plus thymosin for 1 year, entecavir for another additional 0.5 year. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- entecavir and Thymosin-α
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 21 sitesChina
- Study dates
- Jun 2013to Dec 2016
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients from age 18 to 65 years old;
- Male or female;
- Treatment-naive patients with chronic hepatitis B histologically confirmed of early cirrhosis S4 (similar to metavir F4, Ishak 5/6) who consent to undergo liver biopsy before and after treatment;
- Patients with HBeAg-positive, HBVDNA>2×10<3>IU/ml or patients with HBeAg-negative, HBVDNA>2×10<2> IU/ml；
- Agree to be followed up regularly;
- Signature of written informed consent.
Who cannot join
- Patients with decompensated cirrhosis: including ascites, hepatic encephalopathy, esophageal varices bleeding or other complications of decompensated cirrhosis or hepatocelluar carcinoma;
- Patients who are allergic to entecavir, thymosin or their components, and those considered not suitable for drugs used in this study;
- Patients with HCV or HIV infection, alcoholic liver disease, autoimmune liver disease, genetic liver disease, drug-induced liver injury, severe non-alcoholic fatty liver disease or other chronic liver diseases;
- Patients with baseline AFP level higher than 100 ng/ml and possible malignant lesion on image, or AFP level higher than 100 ng/ml for more than three months;
- Creatinine >1.5×ULN;
- Patients with other uncured malignant tumors;
- Patients with severe diseases of heart, lung, kidney, brain, blood or other organs;
- Patients with any other reasons not suitable for the study.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
China21 sites
Beijing Ditan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100015
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Peking University People's 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
Beijing YouAn Hospital, Capital Medical University
Beijing, Beijing Municipality, 100069
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Peking University
Beijing, Beijing Municipality, 100871
Nanfang Hospital, 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
Huashan Hospital, FuDan University
Shanghai, Shanghai Municipality, 200040
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200040
Shanghai First People's Hospital
Shanghai, Shanghai Municipality, 200080
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, 201508
Shijiazhuang Fifth Hospital
Shijiazhuang, Hebei, 050021
The First Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001
The Hospital Affiliated to Logistics University of Chinese People's Armed Police Force
Tianjin, Tianjin Municipality, 300162
Tongji Hospital, Tongji Medical College, Huazhong University of Science ＆Technology
Wuhan, Hubei, 300030
The Affiliated Hospital of Yanbian University
Yanji, Jilin, 133000
About this study
Patients with chronic hepatitis B histologically confirmed of early cirrhosis S4 (similar to metavir F4, Ishak 5/6) are randomly assigned in a 1:1 ratio. One arm is entecavir alone for 2 years; the other is entecavir for the first 0.5 year, entecavir plus thymosin for 1 year, entecavir for another additional 0.5 year. Patients will be assessed at baseline, at every six months for blood count, liver function test, HBVDNA, AFP, prothrombin time, liver ultrasonography, and Fibroscan. The second liver biopsy will be performed to evaluate regression rate of liver fibrosis 1.5 years after initial therapy.
- Conditions
- Liver Cirrhosis
- Being tested
- entecavir, Thymosin-α
- Keywords
- Hepatitis B, Liver Cirrhosis, Regression, Efficacy
- Medical subject headings
- Liver Cirrhosis, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
entecavirDrug
Also called entecavir dispersible tablets
anti-viral therapy
Thymosin-αDrug
Also called Zadaxin
antiviral and antifibrosis therapy
| Study group | Role | What they receive |
|---|---|---|
| Entecavir Therapy | Active comparator | Entecavir monotherapy:
entecavir, 0.5mg, qd, oral, for 2 years. Receives: Drug: entecavir |
| Entecavir plus Thymosin-α | Experimental | entecavir plus Thymosin-α 1.6μg, Twice a week, ih, in the middle of 1 year. Receives: Drug: entecavir; Drug: Thymosin-α |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regression of HBV-induced liver cirrhosis
Liver cirrhosis regression of 1 point by Ishak scoring system
Measured: 1.5 to 2 years
Secondary outcomes (4)
Child-Pugh score
Child-Pugh score change after 1 and 2-year treatment
Measured: 1 year and 2 years
HBVDNA undetectable rate
The HBVDNA undetectable rate after 1 and 2-year treatment.
Measured: 1 year and 2 years
Fibroscan value
Fibroscan value change after 1 and 2-year treatment
Measured: 1 year and 2 years
Life Quality
Life quality change after 1 and 2-year treatment by SF-36 and EQ-5D questionaire
Measured: 1 year and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by Beijing Friendship HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University People's Hospital, RenJi Hospital, Peking University, Shanghai Zhongshan Hospital, Fudan University, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Public Health Clinical Center, Nanfang Hospital, Southern Medical University, Sir Run Run Shaw Hospital, Beijing YouAn Hospital, Peking University First Hospital, Beijing 302 Hospital, Peking Union Medical College Hospital, Beijing Ditan Hospital, Beijing Tiantan Hospital, Huashan Hospital, Tongji Hospital, Tang-Du Hospital, Fifth Hospital of Shijiazhuang City, Logistics University of Chinese People's Armed Police Forces, The First Affiliated Hospital of Shanxi Medical University, The Affiliated Hospital of Yanbian University
- Responsible party
- Principal investigator, Hong You, Beijing Friendship Hospital
- Investigators
- Hong You, Doctor, Principal investigator, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01938820
- Sponsor's protocol ID
- 2013ZX10002004-2
- Status last verified
- Jul 2018
- First submitted
- 5 Sep 2013
- Last updated
- 27 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lu Z, Sun YM, Chen S, Meng T, Wang B, Zhou J, Wu X, Zhao X, Ou X, Kong YY, Jia J, Zhao X, You H. Multiple Low-Level Viraemia Suggest Hindered Liver Fibrosis Regression in Chronic Hepatitis B Patients During Antiviral Therapy. J Viral Hepat. 2024 Dec;31(12):898-902. doi: 10.1111/jvh.14012. Epub 2024 Oct 7.
PubMed 39373164
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimized Treatment and Regression of HBV-induced Early Cirrhosis
- ClinicalTrials.gov ID
- NCT01938820
- Acronym / sponsor ID
- 2013ZX10002004-2
- Conditions
- Liver Cirrhosis
- Keywords
- Hepatitis B, Liver Cirrhosis, Regression, Efficacy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Collaborators
- Peking University People's Hospital, RenJi Hospital, Peking University, Shanghai Zhongshan Hospital, Fudan University, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Public Health Clinical Center, Nanfang Hospital, Southern Medical University, Sir Run Run Shaw Hospital, Beijing YouAn Hospital, Peking University First Hospital, Beijing 302 Hospital, Peking Union Medical College Hospital, Beijing Ditan Hospital, Beijing Tiantan Hospital, Huashan Hospital, Tongji Hospital, Tang-Du Hospital, Fifth Hospital of Shijiazhuang City, Logistics University of Chinese People's Armed Police Forces, The First Affiliated Hospital of Shanxi Medical University, The Affiliated Hospital of Yanbian University
- Study start
- Jun 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 10 Sep 2013 (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.
Patients with chronic hepatitis B histologically confirmed of early cirrhosis S4 (similar to metavir F4, Ishak 5/6) are randomly assigned in a 1:1 ratio. One arm is entecavir alone for 2 years; the other is entecavir for the first 0.5 year, entecavir plus thymosin for 1 year, entecavir for another additional 0.5 year. Patients will be assessed at baseline, at every six months for blood count, liver function test, HBVDNA, AFP, prothrombin time, liver ultrasonography, and Fibroscan. The second liver biopsy will be performed to evaluate regression rate of liver fibrosis 1.5 years after initial therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Entecavir Therapy | Active comparator | Drug: entecavirEntecavir monotherapy: entecavir, 0.5mg, qd, oral, for 2 years. |
| Entecavir plus Thymosin-α | Experimental | Drug: entecavir, Drug: Thymosin-αentecavir plus Thymosin-α 1.6μg, Twice a week, ih, in the middle of 1 year. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients from age 18 to 65 years old;
- Male or female;
- Treatment-naive patients with chronic hepatitis B histologically confirmed of early cirrhosis S4 (similar to metavir F4, Ishak 5/6) who consent to undergo liver biopsy before and after treatment;
- Patients with HBeAg-positive, HBVDNA>2×10<3>IU/ml or patients with HBeAg-negative, HBVDNA>2×10<2> IU/ml；
- Agree to be followed up regularly;
Key exclusion criteria (8 listed)
- Patients with decompensated cirrhosis: including ascites, hepatic encephalopathy, esophageal varices bleeding or other complications of decompensated cirrhosis or hepatocelluar carcinoma;
- Patients who are allergic to entecavir, thymosin or their components, and those considered not suitable for drugs used in this study;
- Patients with HCV or HIV infection, alcoholic liver disease, autoimmune liver disease, genetic liver disease, drug-induced liver injury, severe non-alcoholic fatty liver disease or other chronic liver diseases;
- Patients with baseline AFP level higher than 100 ng/ml and possible malignant lesion on image, or AFP level higher than 100 ng/ml for more than three months;
- Creatinine >1.5×ULN;
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 |
|---|---|---|
| entecavirAlso: entecavir dispersible tabletsanti-viral therapy | Drug | Entecavir Therapy, Entecavir plus Thymosin-α |
| Thymosin-αAlso: Zadaxinantiviral and antifibrosis therapy | Drug | Entecavir plus Thymosin-α |
Primary outcome
Regression of HBV-induced liver cirrhosis
Time frame: 1.5 to 2 years
Liver cirrhosis regression of 1 point by Ishak scoring system
4 secondary outcomes
Child-Pugh score
Time frame: 1 year and 2 years
HBVDNA undetectable rate
Time frame: 1 year and 2 years
Fibroscan value
Time frame: 1 year and 2 years
Life Quality
Time frame: 1 year and 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2018.
- Derived from this study: PubMed 39373164Lu Z, Sun YM, Chen S, Meng T, Wang B, Zhou J, Wu X, Zhao X, Ou X, Kong YY, Jia J, Zhao X, You H. Multiple Low-Level Viraemia Suggest Hindered Liver Fibrosis Regression in Chronic Hepatitis B Patients During Antiviral Therapy. J Viral Hepat. 2024 Dec;31(12):898-902. doi: 10.1111/jvh.14012. Epub 2024 Oct 7.
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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.
Hong You, Doctor principal investigator
Beijing Friendship Hospital
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing entecavir and Thymosin-α in people with Liver Cirrhosis, run by Beijing Friendship Hospital at 21 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 6 inclusion and 8 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 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Regression of HBV-induced liver cirrhosis (time frame: 1.5 to 2 years). 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 NCT01938820, which also lists 1 linked publication.
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 Jul 2018.