Liver CirrhosisPhase 4NCT01943617

Optimized Treatment and Regression of HBV-induced Compensated Liver 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.

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

Six hundreds patients with chronic hepatitis B clinically diagnosed as compensated liver cirrhosis are randomly assigned in a 1:1 ratio. One arm is entecavir alone for 2 years; the other is entecavir alone for the first 0.5 year, entecavir plus thymosin-α for 1 year, entecavir for another additional 0.5 year.Patients… 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: 606 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 ;
Male or female;
Treatment-naive patients of clinically diagnosed as HBV-induced compensated cirrhosis(meet one of the following two criterions);
endoscopy: esophageal varices , exclusion of noncirrhotic portal hypertension
if no endoscopy,should meet two of the four Criterias:
Imaging (US, CT or MRI, et al) showing Surface nodularity: Echogenecity

Show all 12Show fewer

Platelet (PLT) < 100×10 < 9 >/L , no other interpretation
Albumin (ALB) < 35.0 g/L, or International Standard Value (INR) > 1.3 (Prothrombin Time (PT) prolonged > 3s), or Cholinesterase (CHE) decrease
Liver stiffness measurement value > 12.4 kpa (ALT<5×ULN)
HBeAg-positive, HBVDNA > 2×10<3> IU/ml or with HBeAg-negative patients, HBVDNA > 2×10<2> IU/ml;
Agree to be followed up regularly;
Signature of written inform 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 medicine 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 100ng/ml and possible malignant lesion on image, or AFP level higher than 100ng/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 system or other organs;
Patients with any other reasons not suitable for the study.

Trial locations and contacts

21 sites in 1 country.

City, postcode or hospital

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
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
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
PeKing University
Beijing, Beijing Municipality, 100871
NanfangHospital,Southern Medical University
Guangzhou, Guangdong, 510515
Sir Run Run Shaw Hospital,School of Medicine,Zhejiang University
Hangzhou, Jiangsu, 310016
RenjiHospital,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, 50021
The First Hospital of Shanxi Medical University
Taiyuan, Shanxi, 30001
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
Yanbian, Jilin, 133000

Other trials in China

About this study

Conditions: Liver Cirrhosis
Being tested: Entecavir, Thymosin-α
Keywords: Liver Cirrhosis, Hepatitis B, Compensation, 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
anti-viral and antitherapy

Study groups in NCT01943617
Study group	Role	What they receive
Entecavir Therapy	Active comparator	Entecavir, 0.5mg, qd, oral, for 2 years Receives: Drug: Entecavir
Entecavir plus thymosin therapy	Experimental	Entecavir plus thymosin-α 1.6μg, Twice a week, ih, in the middle one year Receives: Drug: Entecavir; Drug: Thymosin-α

What is being measured

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

Decompensated rate of Liver Cirrhosis after 2 years treatment
Decompensated rate of Liver Cirrhosis (ascites, hepatic encephalopathy, esophageal varices bleeding and Hepatocellular Carcinoma) after 2 years treatment.
Measured: 2 years

Secondary outcomes (4)

Child-Pugh and MELD scores
The progress of Child-Pugh and MELD scores after 1 and 2-year treatment
Measured: 1 and 2-year
The HBV DNA undetectable rate
The HBV DNA undetectable rate after 1 and 2-year treatment
Measured: 1 and 2-year
Liver stiffness measurement
Liver stiffness measurement change after 1 and 2-year treatment.
Measured: 1 and 2-year
Quality of Life
Quality of life after 1 and 2-year treatment by SF-36 and EQ-5D questionares
Measured: 1 and 2-year

Timeline

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

Jun 2013Dec 2016

First posted17 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 (2)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: 606 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01943617
Sponsor's protocol ID: 2013ZX10002004-3
Status last verified: Jul 2018
First submitted: 5 Sep 2013
Last updated: 27 Jul 2018
Results posted: No
Data monitoring committee: Yes

Publications

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

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

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Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
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RecruitingObservational study
The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
Liver Cirrhosis, Gastroesophageal Varices
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CirrhosisRx CDS System
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Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
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All Liver Cirrhosis trials

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 Compensated Liver Cirrhosis
ClinicalTrials.gov ID: NCT01943617
Acronym / sponsor ID: 2013ZX10002004-3
Conditions: Liver Cirrhosis
Keywords: Liver Cirrhosis, Hepatitis B, Compensation, Efficacy
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 606 participants (actual)
Lead sponsor: Beijing Friendship HospitalUniversity, hospital or other
Collaborators: Peking University People's Hospital, RenJi Hospital, Peking University, Shanghai Zhongshan Hospital, 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: 17 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.

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, 0.5mg, qd, oral, for 2 years
Entecavir plus thymosin therapy	Experimental	Drug: Entecavir, Drug: Thymosin-αEntecavir plus thymosin-α 1.6μg, Twice a week, ih, in the middle one year

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Patients from age 18 to 65 years ;
Male or female;
Treatment-naive patients of clinically diagnosed as HBV-induced compensated cirrhosis(meet one of the following two criterions);
HBeAg-positive, HBVDNA > 2×10<3> IU/ml or with HBeAg-negative patients, 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 medicine 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 100ng/ml and possible malignant lesion on image, or AFP level higher than 100ng/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 therapy
Thymosin-αAlso: Zadaxinanti-viral and antitherapy	Drug	Entecavir plus thymosin therapy

Primary outcome

Decompensated rate of Liver Cirrhosis after 2 years treatment
Time frame: 2 years
Decompensated rate of Liver Cirrhosis (ascites, hepatic encephalopathy, esophageal varices bleeding and Hepatocellular Carcinoma) after 2 years treatment.

4 secondary outcomes

Child-Pugh and MELD scores
Time frame: 1 and 2-year
The HBV DNA undetectable rate
Time frame: 1 and 2-year
Liver stiffness measurement
Time frame: 1 and 2-year
Quality of Life
Time frame: 1 and 2-year

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 34843068Wu 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.
Derived from this study: PubMed 33460002Wu 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.

Related trials for Liver Cirrhosis

RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Recruiting
Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis
Spontaneous Bacterial Peritonitis, Paracentesis
RecruitingObservational study
The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
Liver Cirrhosis, Gastroesophageal Varices
Recruiting
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RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD

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 12 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?

Decompensated rate of Liver Cirrhosis after 2 years treatment (time frame: 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 NCT01943617, which also lists 2 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 27 Jul 2018.