A multicenter randomised study comparing the efficacy of adefovir dipivoxil versus pegylated interferon alpha-2a plus placebo versus adefovir dipivoxil plus peglyated interferon alpha-2a for the treatment of chronic delta hepatitis
| ISRCTN | ISRCTN83587695 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83587695 |
| Secondary identifying numbers | 3388 |
- Submission date
- 03/08/2005
- Registration date
- 09/09/2005
- Last edited
- 02/02/2011
- 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 Michael P Manns
Scientific
Scientific
Medizinische Hochschule Hannover
Department for Gastroenterology, Hepatology and Endocrinology
Carl-Neuberg-Str. 1
Hannover
30625
Germany
| Phone | +49 5115323306 |
|---|---|
| manns.michael@mh-hannover.de |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | Delta Study |
| Study objectives | Peg-interferon alpha-2a or adefovir lead to sustained virological response in 20-40% of the cases in chronic delta hepatitis. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Adults with chronic delta hepatitis |
| Intervention | A: Adefovir dipivoxil, 10 mg, orally (po) for 48 weeks versus B: Pegylated interferon alpha-2a, 180 µg subcutaneously (sc), plus placebo for 48 weeks versus C: Pegylated interferon alpha-2a, 180 µg sc, plus adefovir dipivoxil, 10 mg po for 48 weeks; biopsy at the end of treatment |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Peg-interferon alpha-2a, adefovir dipivoxil |
| Primary outcome measure | Response rate of normal ALT and HDV RNA negativity at the end of treatment (ETR) |
| Secondary outcome measures | 1. Response rate of normal ALT and HDV RNA negativity at the end of follow-up (EOF) 2. Suppression of hepatitis B virus (HBV) DNA below 1x10^5 copies/ml at ETR and EOF 3. Paired biopsy comparison 4. HBsAg levels, loss of HBsAg and HBs Antibodies at ETR and EOF 5. HBV and HDV specific T cell response 6. Saftey (adverse events, vital signs, clinical laboratory parameters) |
| Overall study start date | 01/04/2004 |
| Completion date | 01/10/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 69 |
| Key inclusion criteria | 1. Age >18 years 2. Positive Hepatits B surface Antigen (HBsAg) 3. Positive anti-hepatitis D virus (HDV) antibodies 4. Positive HDV-Ribonucleic Acid (RNA) by Polymerase Chain Reaction (PCR) 5. Serum alanine aminotransferase (ALT) >upper limit of normal (ULN) but <10 x ULN 6. Liver biopsy demonstrating liver disease consistent with chronic heaptitis 7. Liver imaging for patients with cirrhosis or marked fibrosis to rule out hepatic carcinoma 8. Negative urine or serum pregnancy test 9. Willingness to give written informed consent |
| Key exclusion criteria | 1. Antiviral therapy in previous six months 2. Positive tests for hepatitis A virus (HAV) Immunoglobulin M (IgM) antibodies, hepatitis C virus (HCV) RNA or HCV antibodies or Human Immunodeficiency Virus (HIV) antibodies 3. Serum total bilirubin >2 x ULN 4. Decompensated liver disease Child B-C 5. Other reasons for chronic liver disease 6. Haemoglobin <11.5 g/dl for females and <12.5 g/dl for males 7. White blood cell count (WBC) <3000 cells/mm^3 8. Serum creatinine >1.5 x ULN 9. Relevant psychiatric diseases 10. Drug or alcohol abuse within one year of entry 11. Other evidence or histroy of severe illness 12. Thyroid disease poorly controlled 13. Alphafetoprotein (AFP) >100 ng/ml |
| Date of first enrolment | 01/04/2004 |
| Date of final enrolment | 01/10/2004 |
Locations
Countries of recruitment
- Germany
Study participating centre
Medizinische Hochschule Hannover
Hannover
30625
Germany
30625
Germany
Sponsor information
Hannover Medical School (MHH) (Germany)
University/education
University/education
Kompetenznetz Hepatitis (Hep-Net e.V.)
Department for Gastroenterology, Hepatology and Endocrinology
Carl-Neuberg-Str. 1
Hannover
30625
Germany
| Website | http://www.kompetenznetz-hepatitis.de |
|---|---|
"ROR" |
https://ror.org/00f2yqf98 |
Funders
Funder type
University/education
Network of competence for hepatitis (Kompetenznetz Hepatitis [Hep-Net e.V.]), c/o Hannover Medical School (Medizinische Hochschule Hannover [MHH]) (Germany)
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 | 27/01/2011 | Yes | No |
