Valopicitabine When Administered Alone and in Combination With Interferon to Treatment-Naive Patients With Hepatitis C

NCT ID: NCT00120835

Last Updated: 2010-06-10

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

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Brief Summary

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This study is being conducted in treatment-naive patients (no previous hepatitis C treatment) to evaluate the safety of valopicitabine (NM283) alone and together with pegylated interferon, a drug approved by the Food and Drug Administration for the treatment of hepatitis C infection. This study is also evaluating the ability of valopicitabine to decrease the amount of hepatitis C virus in the body. The results for patients taking valopicitabine alone will be compared with the results for patients taking valopicitabine together with pegylated interferon.

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Documented clinical history compatible with genotype-1, chronic hepatitis C infection
* Treatment-naive (patient has received no previous therapy for hepatitis C viral infection)

Exclusion Criteria

* Patient is pregnant
* Patient is co-infected with hepatitis B or HIV
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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Bradenton, Florida, United States

Site Status

San Antonio, Texas, United States

Site Status

Santurce, , Puerto Rico

Site Status

Countries

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United States Puerto Rico

Other Identifiers

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NV-08A-003

Identifier Type: -

Identifier Source: org_study_id

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