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A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ABT-450 With Ritonavir (ABT-450/r) When Given Together With ABT-333 and Ribavirin (RBV) in Treatment-Naïve and Non-responder Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection

NCT ID: NCT01306617

Last Updated: 2015-01-08

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2012-10-31

Brief Summary

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The purpose of this study is to evaluate the antiviral activity, safety, and pharmacokinetics of ABT-450 with ritonavir (ABT-450/r) dosed in combination with ABT-333 (also known as dasabuvir) and ribavirin (RBV) in treatment-naïve and non responder participants with genotype 1 chronic hepatitis C virus (HCV) infection.

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Detailed Description

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This was a phase 2a multicenter, open-label, sequential, 3-arm, combination treatment study of a regimen of ABT-450/r/ABT-333, and ribavirin (RBV) in hepatitis C virus (HCV) genotype 1-infected treatment-naïve participants and previous non-responders to pegylated interferon (pegIFN)/RBV treatment.

Conditions

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Chronic Hepatitis C Infection Hepatitis C Hepatitis C Virus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ABT-450/r (250/100 mg) and ABT-333 plus RBV in treatment-naïve

ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.

Group Type EXPERIMENTAL

ABT-450

Intervention Type DRUG

tablets

ABT-333

Intervention Type DRUG

tablets

ribavirin

Intervention Type DRUG

tablets

ritonavir

Intervention Type DRUG

capsules

ABT-450/r (150/100 mg) and ABT-333 plus RBV in treatment-naïve

ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.

Group Type EXPERIMENTAL

ABT-450

Intervention Type DRUG

tablets

ABT-333

Intervention Type DRUG

tablets

ribavirin

Intervention Type DRUG

tablets

ritonavir

Intervention Type DRUG

capsules

ABT-450/r (150/100 mg) and ABT-333 plus RBV in non-responders

ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.

Group Type EXPERIMENTAL

ABT-450

Intervention Type DRUG

tablets

ABT-333

Intervention Type DRUG

tablets

ribavirin

Intervention Type DRUG

tablets

ritonavir

Intervention Type DRUG

capsules

Interventions

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ABT-450

tablets

Intervention Type DRUG

ABT-333

tablets

Intervention Type DRUG

ribavirin

tablets

Intervention Type DRUG

ritonavir

capsules

Intervention Type DRUG

Other Intervention Names

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dasabuvir Norvir

Eligibility Criteria

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Inclusion Criteria

* Chronic hepatitis C virus (HCV)
* Treatment naive, null or partial responders to previous treatment with peginterferon and ribavirin
* Males and females 18-65 years old
* Body mass index 18 to \< 35 kg/m\^2
* Females must be postmenopausal for at least 2 years or surgically sterile

Exclusion Criteria

* Cirrhosis or extensive bridging fibrosis
* History of cardiac disease
* Positive screen for certain drugs or alcohol
* Abnormal laboratory results
* Significant sensitivity to any drug
* Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody
* Use of strong cytochrome P450 3A (CYP3A), cytochrome P450 2C8 (CYP2C8), and organic anion transporting polypeptide 1B1 (OATP1B1) enzyme inducers or inhibitors within 1 month of dosing
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel Cohen, MD

Role: STUDY_DIRECTOR

AbbVie

Locations

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Site Reference ID/Investigator# 48263

Los Angeles, California, United States

Site Status

Site Reference ID/Investigator# 48264

Aurora, Colorado, United States

Site Status

Site Reference ID/Investigator# 51282

Gainesville, Florida, United States

Site Status

Site Reference ID/Investigator# 50425

Springfield, Massachusetts, United States

Site Status

Site Reference ID/Investigator# 50423

Kansas City, Missouri, United States

Site Status

Site Reference ID/Investigator# 48268

New York, New York, United States

Site Status

Site Reference ID/Investigator# 50428

Statesville, North Carolina, United States

Site Status

Site Reference ID/Investigator# 48266

San Antonio, Texas, United States

Site Status

Site Reference ID/Investigator# 50427

Newport News, Virginia, United States

Site Status

Site Reference ID/Investigator# 48265

Seattle, Washington, United States

Site Status

Site Reference ID/Investigator# 50424

Madison, Wisconsin, United States

Site Status

Countries

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United States

References

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Poordad F, Lawitz E, Kowdley KV, Cohen DE, Podsadecki T, Siggelkow S, Heckaman M, Larsen L, Menon R, Koev G, Tripathi R, Pilot-Matias T, Bernstein B. Exploratory study of oral combination antiviral therapy for hepatitis C. N Engl J Med. 2013 Jan 3;368(1):45-53. doi: 10.1056/NEJMoa1208809.

Reference Type DERIVED
PMID: 23281975 (View on PubMed)

Related Links

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http://rxabbvie.com

Related Info

Other Identifiers

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M12-746

Identifier Type: -

Identifier Source: org_study_id

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