Acute Hepatitis B MedDRA version: 8.1 Level: LLT Classification code 10059193 Term: Acute hepatitis B
Conditions
Interventions
Trade Name: Zeffix
Product Name: Zeffix
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Lamivudin
CAS Number: 159989-64-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentr
Sponsors
University of Leipzig
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: - Is the time to clear HBV-DNA/HBeAg/HBsAg and/or development of anti-HBe/anti- HBs shortened by the treatment with lamivudine? - Is the rate of HBsAg positive patients at 6 resp. 12 month lowered by the treatment with lamivudine? - If initiallly abnormal: Is the time to normalization of prothrombin time (Quick =70%) and liver enzymes ALAT, ASAT shortened by the treatment with lamivudine? - Is the rate of patients progressing to fulminant hepatitis lowered by the treatment with lamivudine? - Is the rate of Adverse and Serious Adverse Events similar in both treatment arms? - For patients with ongoing employment relationship: Is the time to end of absence from work shortened by the treatment with lamivudine? In addition, the aspects of quality of life/physical capacity resp. health economics will be adressed within two independent sub-studies.;Main Objective: - Is time to bilirubin < 2mg/dl shortened by the treatment with lamivudine? ;Primary end point(s): Time until Bilirubin < 2 mg/dl | — |
Countries
Germany
Outcome results
None listed