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

ISRCTN	ISRCTN07772084
DOI	https://doi.org/10.1186/ISRCTN07772084
Clinical Trials Information System (CTIS)	2005-005987-94
Protocol serial number	N/A
Sponsor	University of Leipzig (Germany)
Funder	The GAHB-Study is funded by a grant of the Bundesministerium für Bildung und Forschung Förderkennzeichen 01KG0507

Submission date: 10/01/2007
Registration date: 22/02/2007
Last edited: 09/05/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Hans Ludger Tillmann
Scientific

Universität Leipzig
Medizinische Klinik II
Philipp Rosenthal Str. 27
Leipzig
04103
Germany

Phone	+49 (0) 341 9712231
Email	hans.tillmann@medizin.uni-leipzig.de

Study information

Primary study design	Interventional
Study design	Double-blind placebo-controlled randomised two-armed parallel-group phase IIb multi-centre trial
Secondary study design	Randomised controlled trial
Scientific title	German Acute Hepatitis B Study: a double-blind placebo-controlled randomised two-armed parallel-group phase IIb multi-centre trial
Study acronym	GAHB-Study
Study objectives	Early intervention with the antiviral drug lamivudine leads to earlier recovery from acute hepatitis B
Ethics approval(s)	Ethics committee of University Leipzig, approved on 29.11.2006, Bearbeitungs-Nr. 101-06 ff
Health condition(s) or problem(s) studied	Acute Hepatitis B
Intervention	Administration of lamivudine versus placebo
Intervention type	Other
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	31/12/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target sample size at registration	140
Total final enrolment	35
Key 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
Key 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)
Date of first enrolment	31/12/2006
Date of final enrolment	31/12/2009

Locations

Countries of recruitment

Germany

Study participating centre

Universität Leipzig

Leipzig
04103
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2014	09/05/2019	Yes	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

09/05/2019: Publication reference and total final enrolment added.