Retreatment of hepatitis C non-responsive to Interferon: a placebo controlled randomised trial of Ribavirin monotherapy versus combination therapy with Ribavirin and Interferon in 121 patients in the Benelux
| ISRCTN | ISRCTN53821378 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN53821378 |
| Secondary identifying numbers | N/A |
- Submission date
- 30/07/2003
- Registration date
- 11/08/2003
- Last edited
- 05/09/2007
- 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 Solko Walle Schalm
Scientific
Scientific
Dr. Molewaterplein 40
Rotterdam
3015 GD
Netherlands
| Phone | +31 (0)10 4633793 |
|---|---|
| s.schalm@erasmusmc.nl |
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 | Retreatment of hepatitis C non-responsive to Interferon. |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Chronic hepatitis C |
| Intervention | Patients were randomised to: 1. 6 months combination therapy with interferon alpha-2b (3 MU tiw) and ribavirin (1000 - 1200 mg / day) 2. 6 months ribavirin monotherapy (1000 - 1200 mg / day) 3. 6 months ribavirin placebo |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Ribavirin monotherapy, Ribavirin and Interferon combination |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/1992 |
| Completion date | 01/01/1996 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 117 |
| Key inclusion criteria | Patients with chronic hepatitis C and elevated transaminases who did not respond to previous treatment with standard interferon monotherapy. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/1992 |
| Date of final enrolment | 01/01/1996 |
Locations
Countries of recruitment
- Belgium
- Netherlands
Study participating centre
Dr. Molewaterplein 40
Rotterdam
3015 GD
Netherlands
3015 GD
Netherlands
Sponsor information
Schering Plough International (USA)
Industry
Industry
c/o Janice K. Albrecht
Vice President Clinical Research
Hepatology/GI
2000 Galloping Hill Road
Kenilworth, New Jersey
07033-0530
United States of America
| Phone | +1 908 298 2868 |
|---|---|
| janice.albrecht@spcorp.com | |
| Website | http://www.schering.com/ |
"ROR" |
https://ror.org/02891sr49 |
Funders
Funder type
Research organisation
Foundation for Liver Research in Rotterdam (The Netherlands)
No information available
ICN Pharmaceuticals and Schering Plough International provided free drug and placebo and financial support
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 | 29/08/2003 | Yes | No |
