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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN53821378 |
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Date of registration:
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11/08/2003 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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Date of first enrolment:
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01/01/1992 |
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Target sample size:
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117 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN53821378 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial (Treatment)
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Phase:
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Countries of recruitment
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Belgium
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Netherlands
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Contacts
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Name:
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Solko Walle
Schalm |
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Address:
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Dr. Molewaterplein 40
3015 GD
Rotterdam
Netherlands |
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Telephone:
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+31 (0)10 4633793 |
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Email:
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s.schalm@erasmusmc.nl |
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Affiliation:
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Name:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Patients with chronic hepatitis C and elevated transaminases who did not respond to previous treatment with standard interferon monotherapy.
Exclusion criteria: Not provided at time of registration
Age minimum:
Age maximum:
Gender:
Not Specified
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Health Condition(s) or Problem(s) studied
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Chronic hepatitis C
Infections and Infestations
Hepatitis
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Intervention(s)
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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
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Primary Outcome(s)
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Not provided at time of registration
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Secondary Outcome(s)
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Not provided at time of registration
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Source(s) of Monetary Support
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Foundation for Liver Research in Rotterdam (The Netherlands), ICN Pharmaceuticals and Schering Plough International provided free drug and placebo and financial support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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