Condition category
Infections and Infestations
Date applied
30/07/2003
Date assigned
11/08/2003
Last edited
05/09/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

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 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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial 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

Phase

Not Specified

Drug names

Ribavirin monotherapy, Ribavirin and Interferon combination

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/1992

Overall trial end date

01/01/1996

Reason abandoned

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

Patient

Age group

Not Specified

Gender

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

Trial 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

http://www.schering.com/

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in: http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&list_uids=12948399

Publication citations

  1. Results

    Veldt BJ, Brouwer JT, Adler M, Nevens F, Michielsen P, Delwaide J, Hansen BE, Schalm SW, , Retreatment of hepatitis C non-responsive to interferon. A placebo controlled randomized trial of ribavirin monotherapy versus combination therapy with Ribavirin and Interferon in 121 patients in the Benelux [ISRCTN53821378]., BMC Gastroenterol, 2003, 3, 24, doi: 10.1186/1471-230X-3-24.

Additional files

Editorial Notes