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Main
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Note: This record shows only the 20 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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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00724373 |
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Date of registration:
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25/07/2008 |
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Primary sponsor: |
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Public title:
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Study of HCV Genotype 1 Patients in the UK Treated With ViraferonPeg and Rebetol (Study P05269)(COMPLETED)
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Scientific title:
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Retrospective Data Study of HCV Genotype 1 Patients in the UK Treated With ViraferonPeg and Rebetol |
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Date of first enrolment:
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November 2007 |
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Target sample size:
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442 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00724373 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Retrospective
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Countries of recruitment
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United Kingdom
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Participants with genotype 1 HCV infection who have been treated with pegylated
interferon alfa-2b and ribavirin in the preceding 48 months will be included. They
will be divided into:
- Completer participants: Patients with a diagnosis of HCV genotype 1 who have
completed a course of interferon alfa-2b and ribavirin, with no prior treatment for
HCV (ie, previously treatment naïve). Completer participants must have at least 24
weeks of follow up data available post completion of treatment to ensure ability to
assess SVR rates.
- Early terminators: Participants who have terminated treatment early due to adverse
events or other reasons (ie, exposure is incomplete).
Exclusion Criteria:
- Participants currently undergoing therapy and therefore have not terminated
treatment, ie, exposure is still ongoing.
- Co-infected HCV participants (eg, human immunodeficiency virus [HIV] or hepatitis B
virus [HBV]).
- Participants who received their first HCV treatment in relation to a clinical trial.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hepatitis C, Chronic
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Intervention(s)
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Biological: Peginterferon alfa-2b (SCH 54031)
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Drug: Ribavirin (SCH 18908)
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Primary Outcome(s)
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Participants With Treatment Success
[Time Frame: Data will be collected from the start of first exposure to pegylated interferon alfa-2b and ribavirin combination therapy. Participants who have successfully completed treatment will have data collected for a follow-up period of at least 24 weeks.]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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