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Hepatitis B Virus Related CirrhosisPhase 4NCT02241616

Traditional Chinese Medicine Combined With Entecavir to Treat Refractory Liver Fibrosis in Liver Cirrhosis Due to HBV

A Phase 4 study testing Entecavir+Fuzheng Huayu+TCM Granule in people with Hepatitis B Virus Related Cirrhosis, run by ShuGuang 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Liver Cirrhosis is a common pathological consequence of chronic liver disease. Hepatitis B Virus (HBV) is one of most etiologies of Liver cirrhosis in China. The effective inhibition of HBV can partially regress or reverse liver fibrosis in patients with chronic Hepatitis and liver cirrhosis due to HBV, however some… Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Hepatitis B Virus Related Cirrhosis
What is being tested?
Entecavir+Fuzheng Huayu+TCM Granule
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
350 participants
Where
20 sitesChina
Study dates
Sep 2014to Jun 2019
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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Hepatitis B history or more than 6 months history of positive HBsAg
  • Within 2 years of Entecavir treatment, HBV-DNA is negative but has not reach the clinical endpoint (HBeAg seroconversion or HBsAg loss in HBeAg-positive patients; HBsAg loss or anti-HBs seroconversion in HBeAg-negative patients)
  • Age 18-60
  • Ishak fibrosis score of the biopsy within 6 months ≥5, no anti-fibrosis drug was taken within 6 months.
  • Child-Pugh<7 (Stage A)
  • The patient or the patient's guardian agrees to participate the random controlled trial and sign the Informed Consent Form.

Who cannot join

  • Decompensated liver cirrhosis
  • HCC
  • Liver histology conforming to other chronic liver diseases, such as moderate or severe non-alcoholic fatty liver disease(more than 1/3 steatosis in liver ), chronic hepatitis C, chronic hepatitis D, autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, inherited metabolic liver disease, drug or toxic induced liver injury, parasitic infections, alcoholic liver disease.
  • Have psychiatric history or uncontrollable epilepsy patient.
  • Uncontrollable diabetic patient
  • History of hemoglobin disease (such as alpha- or beta-thalassemia, sickle cell disease, spherocytosis) or patients with toxic or autoimmune hemolytic anemia.
Show all 14Show fewer
  • Severe background disease like chronic respiratory failure, circulatory failure, kidney failure etc.
  • In situ organ transplantation (such as liver, kidney, lung and heart) or bone marrow transplantation and stem cell transplantation.
  • Immunocompromised patients: such as HIV infection or take immunosuppressor or Glucocorticoid (such as cyclosporin, azathioprine, adrenocortical hormone) within 3 months or chemotherapy drugs (such as cyclophosphamide, ammonia and cancer chemotherapy) and radioactive therapy.
  • Gestation or lactation period women and women who plan to get pregnant during the study period.
  • Patient who are allergy to the experimental drug.
  • Using history of other anti-viral drug within 6 months.
  • Patients who are participating other trials.
  • Other situation where PI thinks the patient should be excluded.

Trial locations and contacts

20 sites in 1 country.

Chenghai Liu, PhD contact

8621-20256521

chenghailiu@hotmail.com

20 sites in 1 country

China20 sites, 20 recruiting

  • The Fifth People's Hospital of Anyang

    Anyang, Henan

    Recruiting

  • Beijing Ditan Hospital Capital Medical University

    Beijing

    Recruiting

  • Beijing Youan Hospital Capital Medical University

    Beijing

    Recruiting

  • China-Japan Friendship Hospital

    Beijing

    Recruiting

  • The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine

    Changsha, Hunan

    Recruiting

  • Huai'an No. 4 People's Hospital

    Huai'an, Jiangsu

    Recruiting

  • Affiliated Hospital of Shandong Univercity of TCM

    Jinan, Shandong

    Recruiting

  • Jingmen No.1 People's Hospital

    Jingmen, Hubei

    Recruiting

  • The Ninth Hospital of Nanchang

    Nanchang, Jiangxi

    Recruiting

  • Guangxi Ruikang Hospital

    Nanning, Guangxi

    Recruiting

  • ShuGuang Hospital

    Shanghai, 201203

    Zhimin Zhao, PhD, +8615800581663, kilorair@sina.com

    Chenghai Liu, PhD

    Recruiting

  • Ruijin Hospital

    Shanghai

    Recruiting

  • Shanghai Zhongshan Hospital

    Shanghai

    Recruiting

  • Shenzhen Third People's Hospital

    Shenzhen

    Recruiting

  • The Fifth Hospital of Shijiazhuang

    Shijiazhuang, Hebei

    Recruiting

  • The Fifth People's Hospital of Suzhou

    Suzhou, Jiangsu

    Recruiting

  • Wenzhou Central Hospital

    Wenzhou, Zhejiang

    Recruiting

  • Hubei Hospital of TCM

    Wuhan, Hubei

    Recruiting

  • Tongji Hospital

    Wuhan, Hubei

    Recruiting

  • Ningxia People's Hospital

    Yinchuan, Ningxia

    Recruiting

Other trials in China

About this study

Official title: A Multi-Center Study to Assess the Efficacy and Safety of Traditional Chinese Medicine Combined With Entecavir for Patients With Refractory Liver Fibrosis in Liver Cirrhosis Due to HBV

Liver Cirrhosis is a common pathological consequence of chronic liver disease. Hepatitis B Virus (HBV) is one of most etiologies of Liver cirrhosis in China. The effective inhibition of HBV can partially regress or reverse liver fibrosis in patients with chronic Hepatitis and liver cirrhosis due to HBV, however some patients keep existence or development although HBV DNA is under-detectable after anti-virals. Theses refractory liver fibrosis is required the anti-fibrotic treatment focusing on the regulation of hepatic extracellular matrix, especially is necessary for in the patients with advance fibrosis stage ie. liver cirrhosis. Fuzheng Huayu has been found to enhance the degradation of collagens in fibrotic liver and have a good action against liver fibrosis in patients with chronic hepatitis B. However, there are no high quality clinical evidences which can demonstrate if the combination of anti-viral and anti-fibrotic therapy can improve the reversion of refractory liver fibrosis in liver cirrhosis due to HBV.

The primary objective of this study is to establish the safety and efficacy of the combination of Entecavir and Traditional Chinese Medicine in refractory liver fibrosis in liver cirrhosis due to HBV.

Being tested
Entecavir+Fuzheng Huayu+TCM Granule

What participants receive

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

  • Entecavir+Fuzheng Huayu+TCM GranuleDrug

    Also called Gan Ping, 319 Recipe, FZHY

    The subjects will be taking 1 Entecavir tablet per day, 4 Fuzheng Huayu tablets three times a day and specific Traditional Chinese Medicine granule for 48 weeks.

Study groups in NCT02241616
Study groupRoleWhat they receive
Entecavir+Fuzheng Huayu+TCM GranuleExperimentalTablet with Entecavir+ Tablet with Fuzheng Huayu+ Granule with TCM
Receives: Drug: Entecavir+Fuzheng Huayu+TCM Granule

What is being measured

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

  1. Degree of liver fibrosis

    The collagen of liver tissue from 48 week post-treatment patients was stained. 3 pathologists read the slides independently and score the slides with Ishak system. If the Ishak score decrease 1 or more than 1 score, then it is recorded as regression.

    Measured: 48 weeks

Timeline

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

  1. First posted16 Sep 2014 (estimated)
  2. Study startSep 2014
  3. Primary completionJun 2019 (estimated)
  4. Study completionJun 2019 (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
350 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02241616
Sponsor's protocol ID
SGHLC20140818002
Status last verified
Oct 2018
First submitted
12 Sep 2014
Last updated
15 Oct 2018
Results posted
No
Data monitoring committee
No

Publications

  • Chen Y, Zhao Z, Fan H, Li Z, He Y, Liu C. Safety and therapeutic effects of anti-fibrotic Traditional Chinese Medicine Fuzheng Huayu on persistent advanced stage fibrosis following 2 years entecavir treatment: Study protocol for a single arm clinical objective performance criteria trial. Contemp Clin Trials Commun. 2020 Jun 23;19:100601. doi: 10.1016/j.conctc.2020.100601. eCollection 2020 Sep.

    PubMed 32642592

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Entecavir+Fuzheng Huayu+TCM Granule in people with Hepatitis B Virus Related Cirrhosis, run by ShuGuang 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 6 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 15 Oct 2018. 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?

Contact Chenghai Liu, PhD (8621-20256521, chenghailiu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Degree of liver fibrosis (time frame: 48 weeks). 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 NCT02241616, 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 15 Oct 2018.

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