Comparison of PEG-Intron and Two Different Doses of Ribavirin for the Treatment of Chronic Hepatitis C In Treatment Naïve Subjects
NCT ID: NCT00299936
Last Updated: 2006-03-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
5000 participants
INTERVENTIONAL
Brief Summary
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Detailed Description
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This study will evaluate the safety and efficacy of two different PEG-interferon and Ribavirin regimens in patients who have not previously been treated for Hepatitis C. Patients have an equal chance to assignment to one of two treatment arms:
Treatment Arm A:
PEG-interferon 1.5 mcg/kg2 QW + Ribavirin 800 mg/day
OR
Treatment Arm B:
PEG-interferon 1.5mcg/kg2 QW + Ribavirin 800 to 1400 mg/day
Arm A \& Arm B: Duration of treatment will be 48 weeks for genotype 1 patients and 24 or 48 weeks for genotype 2 or 3 patients.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Ribavirin, PEG-Intron
Eligibility Criteria
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Inclusion Criteria
18 Years
70 Years
ALL
No
Sponsors
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Schering-Plough
INDUSTRY
Weill Medical College of Cornell University
OTHER
Principal Investigators
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Ira M Jacobson, MD
Role: PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University
References
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Hu KQ, Freilich B, Brown RS, Brass C, Jacobson IM. Impact of Hispanic or Asian ethnicity on the treatment outcomes of chronic hepatitis C: results from the WIN-R trial. J Clin Gastroenterol. 2011 Sep;45(8):720-6. doi: 10.1097/MCG.0b013e31820d35e3.
Jacobson IM, Brown RS Jr, McCone J, Black M, Albert C, Dragutsky MS, Siddiqui FA, Hargrave T, Kwo PY, Lambiase L, Galler GW, Araya V, Freilich B, Harvey J, Griffel LH, Brass CA; WIN-R Study Group. Impact of weight-based ribavirin with peginterferon alfa-2b in African Americans with hepatitis C virus genotype 1. Hepatology. 2007 Oct;46(4):982-90. doi: 10.1002/hep.21670.
Jacobson IM, Brown RS Jr, Freilich B, Afdhal N, Kwo PY, Santoro J, Becker S, Wakil AE, Pound D, Godofsky E, Strauss R, Bernstein D, Flamm S, Pauly MP, Mukhopadhyay P, Griffel LH, Brass CA; WIN-R Study Group. Peginterferon alfa-2b and weight-based or flat-dose ribavirin in chronic hepatitis C patients: a randomized trial. Hepatology. 2007 Oct;46(4):971-81. doi: 10.1002/hep.21932.
Other Identifiers
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WIN-R
Identifier Type: -
Identifier Source: secondary_id
P02314
Identifier Type: -
Identifier Source: org_study_id