Induction of Fibrosis Regression on Patients With Chronic Hepatitis B Infection

NCT ID: NCT01341106

Last Updated: 2015-09-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2015-04-30

Brief Summary

This study will examine whether 12 month treatment with entecavir(Baraclude®) has an effect on changes of liver stiffness measurement (LSM) and of hyaluronan measurement in patients with chronic hepatitis B infection.

Detailed Description

Patients with chronic hepatitis B infection and relevant liver fibrosis will be treated with entecavir during 5 years or until anti-HBs seroconversion or 6-12 months after anti-HBe seroconversion and HBeAg loss. There are 9 visits during treatment for each patient. At all visits, each patient will consent to give 20 ml blood sample for study examination and 40 ml blood sample for research purposes.

Conditions

Hepatitis B, Chronic; Liver Fibrosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Treatment Arm

Patients will be treated with entecavir

Group Type: EXPERIMENTAL

Treatment with entecavir(Baraclude®)

Intervention Type: DRUG

Patient will be daily treated with 1 tablet of entecavir per oral

Interventions

Treatment with entecavir(Baraclude®)

Patient will be daily treated with 1 tablet of entecavir per oral

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• chronic hepatitis B infection with detectable HBV (hepatitis B virus)-DNA at baseline
• results of a current liver biopsy (date of liver biopsy must not be longer than 3 months as date of screening visit)
• detection of relevant liver fibrosis in liver histology after percutaneous or laparoscopic biopsy (histologically ≥ F2) after estimation by an experienced pathologist in the liver pathology and sufficient evaluability of the biopsy (usually evaluation of portal at least 8 fields)
• Therapy indication according to current guidelines cHBV infection ( any virus replication in the presence of liver cirrhosis, or detection of HBV-DNA ≥ 2000 IU / ml and/or liver histology with inflammatory Grade ≥2 / fibrosis stage 2 and presence of ALT <5 x ULN)
• non-pregnant and non-breastfeeding women, who fitful one of following criteria: * post-menopausal (12 months natural amenorrhea or 6 months amenorrhea with serum FSH (follicle stimulating hormone)> 40mlU/ml)

• 6 weeks after surgical sterilization by bilateral tubal transection or after bilateral oophorectomy with or without hysterectomy
• Correct application of two methods of sure contraception (any combination of a hormonal contraceptive (the pill, hormone IUD (intrauterine device), Depo-Provera, Implanon, contraceptive patch or vaginal ring) or IUD with a barrier contraceptive with spermicide (diaphragm, cervical cap, LEA contraceptive, female condoms or condom)or a spermicide.
• Sexual abstinence for 2 weeks before the first administration of the study medication, during the study period and after the study during 30 days (time of elimination of study medication)
• Patients, who have only female sexual partners
• Male partner of a female patient, who before study inclusion, sterile and only one sexual partner of this female patient is
• Patients willing and able to complete the requirements of this study

Exclusion Criteria

• anamnestic known hypersensitivity to Baraclude® or its ingredients or to drugs with similar chemical structure
• Participation of patients in another clinical study within last 4 weeks prior to the inclusion or simultaneous participation in another clinical study
• anamnestic known substance dependance or another diseases, which not allowed persons to understand essence and importance and possible consequences of the trial
• lack of cooperation and informed consent
• co-infection with hepatitis C, hepatitis D or HIV
• detection of hepatocellular carcinoma
• serious, chronic disease with an estimated prognosis for survival shorter than the study period of 5 years
• every previous therapy with lamivudine or telbivudine or previous therapy with other antiviral substance within last 6 months before study inclusion
• contraindications to the use of entecavir
• creatinine clearance <50 ml / min and / or need for hemodialysis
• MELD score >15 points and / or detection of ascites

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hannover Medical School

OTHER

Sponsor Role: collaborator

RWTH Aachen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christian Trautwein, Professor MD

Role: PRINCIPAL_INVESTIGATOR

Department of Internal Medicine III, University Hospital Aachen

Locations

Department of Internal Medicin III, University Hospital Aachen

Aachen, North Rhine-Westphalia, Germany

Countries

Germany

Other Identifiers

2010-019884-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

11-018

Identifier Type: OTHER

Identifier Source: secondary_id

CTC-A 11-018

Identifier Type: -

Identifier Source: org_study_id