NCT00299936

Brief Summary

The purpose of this study is to compare PEG-interferon alfa-2b and two different doses of rivavirin for the treatment of chronic hepatitis C in previously untreated adult subjects

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 7, 2006

Completed
Last Updated

March 7, 2006

Status Verified

March 1, 2006

First QC Date

March 3, 2006

Last Update Submit

March 3, 2006

Conditions

Chronic Hepatitis C

Keywords

hepatitis Cchronic hepatitis CribavirinWIN-R

Interventions

Ribavirin, PEG-IntronDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Adult naive subjects with a diagnosis of compensated chronic hepatitis C (HCV RNA+) who have not previously been treated with interferon, PEG-interferon, ribavirin, or combination interferon + ribavirin are being selected for the study.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 21836471DERIVED

  • 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.

    PMID: 17894323DERIVED

  • 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.

    PMID: 17894303DERIVED

MeSH Terms

Conditions

Hepatitis C, ChronicHepatitis C

Interventions

Ribavirinpeginterferon alfa-2b

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RibonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Ira M Jacobson, MD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 3, 2006

First Posted

March 7, 2006

Last Updated

March 7, 2006

Record last verified: 2006-03