Contact information
Type
Scientific
Contact name
Prof Solko Walle Schalm
ORCID ID
Contact details
Dr. Molewaterplein 40
Rotterdam
3015 GD
Netherlands
+31 (0)10 4633793
s.schalm@erasmusmc.nl
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Retreatment of hepatitis C non-responsive to Interferon.
Study hypothesis
Not provided at time of registration
Ethics approval(s)
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Not specified
Study type
Treatment
Patient information sheet
Condition
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
Overall study end date
01/01/1996
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients with chronic hepatitis C and elevated transaminases who did not respond to previous treatment with standard interferon monotherapy.
Participant type(s)
Patient
Age group
Not Specified
Sex
Not Specified
Target number of participants
117
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/1992
Recruitment end date
01/01/1996
Locations
Countries of recruitment
Belgium, Netherlands
Study participating centre
Dr. Molewaterplein 40
Rotterdam
3015 GD
Netherlands
Sponsor information
Organisation
Schering Plough International (USA)
Sponsor details
c/o Janice K. Albrecht
Vice President Clinical Research
Hepatology/GI
2000 Galloping Hill Road
Kenilworth
New Jersey
07033-0530
United States of America
+1 908 298 2868
janice.albrecht@spcorp.com
Sponsor type
Industry
Website
ROR
Funders
Funder type
Research organisation
Funder name
Foundation for Liver Research in Rotterdam (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
ICN Pharmaceuticals and Schering Plough International provided free drug and placebo and financial support
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 29/08/2003 | Yes | No |