Reducing liver fibrosis in patients with chronic Hepatitis B infectio

Phase 1

• Conditions: Patients with chronic hepatitis B infection and a relevant grade of fibrosis (histological >= F2); MedDRA version: 15.0Level: LLTClassification code 10008910Term: Chronic hepatitis BSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2010-019884-12-DE
• Lead Sponsor: niversitätsklinikum Aachen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-10-14
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

•Patients aged 18 to 75 years at the time of inclusion in the study
•Written informed consent of the patient
•Chronic hepatitis B infection (cHBV) with detectable HBV-DNA at study start
•Availability of results from a recent liver biopsy. The date of the liver biopsy may not be more than six months before the day of the screen-ing visit.
•Evidence for relevant liver fibrosis in the liver histology after percutane-ous or laparoscopic puncture (histologically >= F2) according to the as-sessment of an experienced pathologist and sufficient evaluability of the biopsy material (as a rule, evaluation of at least eight portal fields) or clinical evidence of a liver cirrhosis (on the basis of unequivocal endo-scopic or sonographic indications). The number of patients included with clinical evidence for a liver cirrhosis may not exceed 40%. After in-clusion of 40 patients (= 40%) with clinical evidence for a liver cirrhosis all study centres will be notified not to include more patients from this subgroup
•Therapy indication according to the current guidelines for the cHBV infection (i.e. every virus replication in patients with liver cirrhosis or de-tection of an HBV-DNA >= 2000 IU/ml and/or liver histology with inflam-mation >= degree 2/ fibrosis >= stage 2 and ALT < 5 x ULN)
•Non-pregnant (verified by a negative pregnancy test) and non-breast feeding women fulfilling at least one of the following criteria:
?-post-menopausal (12 months natural amenorrhea or six months amenorrhea with serum FSH > 40mlU/ml)
?-6 weeks after operative sterilisation by bilateral tubal ligation or bi-lateral ovarectomy with or without hysterectomy
?-Correct use of two methods for reliable contraception. This includes any combination of a hormonal contraceptive (pill, intra-uterine spi-ral, depot injection, hormone implant, hormone patch or vaginal ring) or an intra-uterine device with spermicidal barrier contracep-tive agent (diaphragm, cervical cap, lea contraceptivum, femidom or condom) or a spermacide
?-Sexual abstinence from two weeks before the first administration of the investigational medicinal product (IMP), during the entire dura-tion of the study, and 30 days following the study, covering the elimination of the IMP
-Patients with only female sexual partners
-Male partner of a patient who is sterile before inclusion of the fe-male patient in the study and is the only sexual partner of the fe-male patient
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

•Anamnestically known hypersensitivity to Baraclude® or its components or to medication with a similar chemical structure
•Participation of the patient in another clinical study within the last four weeks before inclusion or simultaneous participation in another clinical study
•Anamnestically known addictive or other disorders, which do not allow the person to assess the nature, impact and possible consequences of the clinical study
•Indications that the patient will probably not comply with the study pro-tocol (e.g. lack of willingness to co-operate)
•Anamnestically known co-infection with hepatitis C, hepatitis D or HIV
•Evidence for a hepatocellular carcinoma
•Severe chronic disease with an estimated survival prognosis of less than three years
•Any previous therapy with lamivudine or telbivudine or previous therapy within the last six months before inclusion in the clinical study with an-other active anti-viral drug
•Contra-indications for taking entecavir
•Creatinine clearance < 50ml/min and/or need for haemodialysis
•MELD Score > 15 points and/ or evidence for ascites

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified