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 |
| EudraCT/CTIS number | 2005-005987-94 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Universität Leipzig
Medizinische Klinik II
Philipp Rosenthal Str. 27
Leipzig
04103
Germany
| Phone | +49 (0) 341 9712231 |
|---|---|
| hans.tillmann@medizin.uni-leipzig.de |
Study information
| 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 |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 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 study start date | 31/12/2006 |
| Completion date | 31/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | 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
04103
Germany
Sponsor information
University of Leipzig (Germany)
University/education
University/education
Ritterstr. 26
Leipzig
04103
Germany
| Phone | +49 (0) 341 9712231 |
|---|---|
| hans.tillmann@medizin.uni-leipzig.de | |
"ROR" |
https://ror.org/03s7gtk40 |
Funders
Funder type
Government
The GAHB-Study is funded by a grant of the Bundesministerium für Bildung und Forschung Förderkennzeichen 01KG0507
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
Editorial Notes
09/05/2019: Publication reference and total final enrolment added.
