A Study to Evaluate the Combination of Pegylated Interferon Alfa Plus Valopicitabine in Patients With Hepatitis C

NCT ID: NCT00118768

Last Updated: 2009-03-02

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

175 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Brief Summary

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This Phase II study is being conducted in treatment-naive patients (no previous antiviral therapy for Hepatitis C infection) with genotype-1 chronic hepatitis C to evaluate the safety and effectiveness of valopicitabine alone and together with Pegylated Interferon (a drug approved by the Food and Drug Administration for the treatment of Hepatitis C infection).

Detailed Description

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Conditions

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Chronic Hepatitis C

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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valopicitabine

Intervention Type DRUG

Pegylated Interferon Alfa

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Documented clinical history of genotype-1 chronic Hepatitis C and compensated liver disease
* Treatment Naive (patient has received no previous treatment for chronic hepatitis C infection)

Exclusion Criteria

* Patient is pregnant or breastfeeding
* Patient is co-infected with HIV or Hepatitis B
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Locations

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Phoenix, Arizona, United States

Site Status

San Diego, California, United States

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San Mateo, California, United States

Site Status

Lakewood, Colorado, United States

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Bradenton, Florida, United States

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Gainesville, Florida, United States

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Atlanta, Georgia, United States

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Chicago, Illinois, United States

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Laurel, Maryland, United States

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Worcester, Massachusetts, United States

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Detroit, Michigan, United States

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Kansas City, Missouri, United States

Site Status

Albuquerque, New Mexico, United States

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New York, New York, United States

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Cincinnati, Ohio, United States

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Philadelphia, Pennsylvania, United States

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Germantown, Tennessee, United States

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San Antonio, Texas, United States

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Tacoma, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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NV-08A-006

Identifier Type: -

Identifier Source: org_study_id

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