Contact information
Type
Scientific
Primary contact
Prof Hans Ludger Tillmann
ORCID ID
Contact details
Universität Leipzig
Medizinische Klinik II
Philipp Rosenthal Str. 27
Leipzig
04103
Germany
+49 (0) 341 9712231
hans.tillmann@medizin.uni-leipzig.de
Additional identifiers
EudraCT number
2005-005987-94
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
GAHB-Study
Study hypothesis
Early intervention with the antiviral drug lamivudine leads to earlier recovery from acute hepatitis B
Ethics approval
Ethics committee of University Leipzig, approved on 29.11.2006, Bearbeitungs-Nr. 101-06 ff
Study design
Double-blind placebo-controlled randomised two-armed parallel-group phase IIb multi-centre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Acute Hepatitis B
Intervention
Administration of lamivudine versus placebo
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Two primary endpoints are to be considered:
1. Time until Bilirubin < 2 mg/dl
2. Time to hospital discharge
They are ranked according to their relevance and reliability
Secondary outcome measures
The secondary endpoints are grouped into three categories according to their meaning:
1. Endpoints related to antiviral response:
1.1 Time to clear HBsAg (HBsAg negative)
1.2 In initially HBeAg positive patients: Time to clear HBeAg (HBeAG negative)
1.3 Rate of HBsAg positive patients at 6 and 12 months, respectively, after start of therapy
1.4 Time to first occurrence of anti-HBs
1.5 In initially HBeAg positive patients: Time to first occurrence of anti-HBe
1.6 Time to clear HBV-DNA (HBV-DNA below level of detection)
2. Endpoints related to liver function:
2.1 Time to normalisation of prothrombin time (Quick >=70% ), if initially abnormal
2.2 Time to normalisation of liver enzymes ALAT, ASAT (according to the appropriate reference levels of the central laboratory)
2.3 Rate of patients progressing to fulminant hepatitis
3. Patient related endpoints:
3.1 Rate of adverse and serious adverse events
3.2 For patients with ongoing employment relationship: time to end of absence from work
Overall trial start date
31/12/2006
Overall trial end date
31/12/2009
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
140
Participant 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)
Recruitment start date
31/12/2006
Recruitment end date
31/12/2009
Locations
Countries of recruitment
Germany
Trial participating centre
Universität Leipzig
Leipzig
04103
Germany
Sponsor information
Organisation
University of Leipzig (Germany)
Sponsor details
Ritterstr. 26
Leipzig
04103
Germany
+49 (0) 341 9712231
hans.tillmann@medizin.uni-leipzig.de
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
The GAHB-Study is funded by a grant of the Bundesministerium für Bildung und Forschung Förderkennzeichen 01KG0507
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary