Condition category
Infections and Infestations
Date applied
10/01/2007
Date assigned
22/02/2007
Last edited
22/02/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.gahb.de

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

Publication citations

Additional files

Editorial Notes