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Study of ABT-333 in Both Healthy Volunteers and Hepatitis C Virus (HCV) + Genotype 1 Infected Subjects | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Study of ABT-333 in Both Healthy Volunteers and Hepatitis C Virus (HCV) + Genotype 1 Infected Subjects

NCT00696904•AbbVie

View on ClinicalTrials.gov

Summary

The purpose of this study is to assess the safety, tolerability, pharmacokinetics of ABT-333 in healthy volunteers and the antiviral activity in HCV infected subjects.

Detailed Description

Phase 1, double-blind, randomized, placebo-controlled clinical trial in healthy and HCV genotype 1 infected adults to evaluate safety, tolerability, antiviral activity and pharmacokinetics of ABT-333.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Main Selection Criteria for Healthy Volunteers:
•* Subject has provided written consent.
•* Subject is in general good health.
•* If female, subject is postmenopausal.
•* If female, subject is not pregnant and is not breast-feeding.
•Main Selection Criteria for HCV+ Subjects:
•* Subject is HAV-IgM, HBsAg or HIV Ab negative.
•* Subject is HCV genotype 1 with HCV RNA of \> 50,000 IU/mL.
•* Subject is excluded if they have previously received antiviral therapy for HCV infection
•* Subjects must demonstrate chronic hepatitis C infection for at least 6 months prior to study enrollment
+1 more criteria

Exclusion Criteria

•See above for main selection criteria

Key Dates

Start Date

June 1, 2008

Primary Completion Date

February 1, 2009

Last Updated

November 21, 2017

Enrollment

133

ACTUAL participants

Conditions

HCV Infection

Interventions

ABT-333

DRUG

Placebo

DRUG

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COMPLETEDNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 21, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of ABT-333 in Both Healthy Volunteers and Hepatitis C Virus (HCV) + Genotype 1 Infected Subjects

Inclusion Criteria

Exclusion Criteria

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