Induction of Fibrosis Regression on Patients With Chronic Hepatitis B Infection

• Status: Terminated
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: RWTH Aachen University
• Collaborators: Hannover Clinical Trial Center GmbH; Hannover Medical School
• Treatments: Entecavir

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