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 |
| Protocol serial number | N/A |
| Sponsor | Schering Plough International (USA) |
| Funders | Foundation for Liver Research in Rotterdam (The Netherlands), ICN Pharmaceuticals and Schering Plough International provided free drug and placebo and financial support |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Ribavirin monotherapy, Ribavirin and Interferon combination |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/01/1996 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 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
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 | 29/08/2003 | Yes | No |
