German Acute Hepatitis B Study: a double-blind placebo-controlled randomised two-armed parallel-group phase IIb multi-centre trial

Not Applicable

Completed

• Conditions: Acute Hepatitis B; Infections and Infestations; Hepatitis B

• Registration Number: ISRCTN07772084
• Lead Sponsor: niversity of Leipzig (Germany)

Brief Summary

2014 results in: https://www.ncbi.nlm.nih.gov/pubmed/24329913 (added 09/05/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-02-22
• Study Completion: 2009-12-31
• Last Update Posted: 27 May 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 35

Inclusion Criteria

1. Acute hepatitis
2. HBsAg positive
3. Compensated liver function (Quick > 50%)
4. Bilirubin > 5mg/dl (i.e. >85µmol/l)
5. ALAT > 10 times upper normal range
6. Age >= 18 years
7. Hospitalization caused by acute hepatitis
8. Time since diagnosis < 8 days
9. Written informed consent of the patient

Exclusion Criteria

1. Known or obvious pre-existing liver disease
2. Ongoing interferon therapy or stop of interferon less than 3 months ago
3. Ongoing drug abuse
4. HIV positive
5. Anti-HCV or HCV-RNA positive
6. Anti-HDV positive
7. Renal insufficiency (creatinine >1.5mg/dl or 135µmol/l)
8. Pregnant or nursing women
9. Women with child bearing potential (< 2 years after last menstruation) without effective contraception
10. Use of oral contraception
11. Patient with transplanted organs
12. Any disease requiring immunosuppressive therapy, incl. cancer chemotherapy
13. Any acute infectious disease requiring administration of sulphonamide/ trimethoprim
14. 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
15. Known hypersensitivity to any of the study drugs or its ingredients
16. Current or recent (within 30 days prior to start of trial treatment) treatment with another investigational drug or participation in another investigational trial
17. Expected low compliance (e.g. by travel distance to trial site)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Two primary endpoints are to be considered:<br> 1. Time until Bilirubin < 2 mg/dl<br> 2. Time to hospital discharge<br> They are ranked according to their relevance and reliability<br>