Double-blind placebo-controlled randomised trial of lamivudine in the treatment of acute hepatitis B - GAHB-Study

• Conditions: Acute Hepatitis B; MedDRA version: 8.1Level: LLTClassification code 10059193Term: Acute hepatitis B

• Registration Number: EUCTR2005-005987-94-DE
• Lead Sponsor: niversity of Leipzig

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04-25
• Last Update Posted: 18 February 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

- Acute hepatitis
- HBsAg positive
- Compensated liver function (Quick > 50%)
- Bilirubin > 5mg/dl (i.e. >85µmol/l)
- ALAT > 10 times upper normal range
- Age >= 18 years
- Time since diagnosis < 8 days
- Written informed consent of the 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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Known or obvious pre-existing liver disease (by e.g. spider naevis, ascites)
- Ongoing interferon therapy or stop of interferon less than 3 months ago
- Ongoing drug abuse
- HIV positive
- Anti-HCV or HCV-RNA positive
- Anti-HDV positive
- Renal insufficiency (creatinine >1.5mg/dl or 135µmol/l)
- Pregnant or nursing women
- Women with child bearing potential (< 2 years after last menstruation) without
effective contraception
- Use of oral contraception
- Patient with transplanted organs
- Any disease requiring immunosuppressive therapy, incl. cancer chemotherapy
- Any acute infectious disease requires administration of sulphonamide/ trimethoprim
- Evidence of any other disease, metabolic dysfunction, physical examination finding,
or clinical laboratory finding giving reasonable suspicion of a disease or condition
that contraindicates use of an investigational drug, or patient at high risk from
treatment complications
- Known hypersensitivity to any of the study drugs or its ingredients
- Current or recent (within 30 days prior to start of trial treatment) treatment with
another investigational drug or participation in another investigational trial
- Expected low compliance (e.g. by travel distance to trial site)

Study & Design

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