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 - Full Text View

Purpose

An Open-Label Study to Evaluate the Antiviral Activity, Safety and Pharmacokinetics of ABT-450 with Ritonavir (ABT-450/r) Dosed in Combination with ABT-333 and Ribavirin (RBV)

Condition	Intervention	Phase
Chronic Hepatitis C Hepatitis C Hepatitis C Virus (HCV)	Drug: ABT-450/r Drug: ABT-333 Drug: ribavirin	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open-Label Pilot Study to Evaluate the Antiviral Activity, Safety and Pharmacokinetics of ABT-450 With Ritonavir (ABT-450/r) Dosed in Combination With ABT-333 and Ribavirin (RBV) in Treatment-Naive and Non-responder Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C

Drug Information available for: Ribavirin Ritonavir

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:

The safety and antiviral activity (proportion of subjects with hepatitis C ribonucleic acid (HCV RNA) < lower limit of detection (LLOD) [ Time Frame: Week 4 through the end of dosing ] [ Designated as safety issue: No ]
Efficacy

Secondary Outcome Measures:

Pharmacokinetics of ABT-450/r and ABT-333 with RBV in HCV-infected subjects [ Time Frame: Baseline to end of dosing ] [ Designated as safety issue: No ]
pharmacokinetics
The percentage of subjects with HCV RNA < 1000 international units per milliliter (IU/mL) at Study Week 2 [ Time Frame: At Week 2 ] [ Designated as safety issue: No ]
Efficacy
The percentage of subjects with HCV RNA < LLOD [ Time Frame: At Week 4 ] [ Designated as safety issue: No ]
Efficacy
The time to failure to suppress or rebound (confirmed increase of at least 0.5 log10 IU/mL above nadir or confirmed HCV RNA > LLOD for subjects who previously achieved LLOD) [ Time Frame: Baseline to end of study (Post-treatment Week 48) ] [ Designated as safety issue: No ]
Efficacy
The time to relapse after the end of treatment [ Time Frame: End of treatment to end of study ] [ Designated as safety issue: No ]
Efficacy
Sustained virologic response 12 weeks post Direct Acting Antiviral therapy [ Time Frame: 12 weeks after end of treatment ] [ Designated as safety issue: No ]
Efficacy
Sustained virologic response 24 weeks post Direct Acting Antiviral therapy [ Time Frame: 24 weeks after end of treatment ] [ Designated as safety issue: No ]
Efficacy
The development and persistence of viral resistance with this treatment regimen [ Time Frame: Baseline to end of study (Post-treatment Week 48) ] [ Designated as safety issue: No ]
Efficacy

Enrollment:	50
Study Start Date:	February 2011
Study Completion Date:	October 2012
Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm 1 High dose ABT-450/r + ABT-333 + RBV dosed in combination for 12 weeks in treatment naive subjects	Drug: ABT-450/r tablets (ABT-450); capsules (ritonavir) Drug: ABT-333 tablet Drug: ribavirin tablets
Experimental: Arm 2 ABT-450/r + ABT-333 + RBV dosed in combination for 12 weeks in treatment naive subjects	Drug: ABT-450/r tablets (ABT-450); capsules (ritonavir) Drug: ABT-333 tablet Drug: ribavirin tablets
Experimental: Arm 3 ABT-450/r + ABT-333 + RBV dosed in combination in previous non-responders to pegIFN and RBV	Drug: ABT-450/r tablets (ABT-450); capsules (ritonavir) Drug: ABT-333 tablet Drug: ribavirin tablets

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

Chronic Hepatitis C Virus (HCV)
Treatment naive or previously treated with pegInterferon and ribavirin
Males and females 18-65 years old
body mass index ≥ 18 to < 35 kg/m2 Exclusion Criteria
Cirrhosis or extensive bridging fibrosis
History of cardiac disease
Positive drug screen
Abnormal laboratory results (see protocol for specifics)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01306617

Locations

United States, California
Site Reference ID/Investigator# 48263
Los Angeles, California, United States, 90048
United States, Colorado
Site Reference ID/Investigator# 48264
Aurora, Colorado, United States, 80045
United States, Florida
Site Reference ID/Investigator# 51282
Gainesville, Florida, United States, 32610
United States, Massachusetts
Site Reference ID/Investigator# 50425
Springfield, Massachusetts, United States, 01105
United States, Missouri
Site Reference ID/Investigator# 50423
Kansas City, Missouri, United States, 64134
United States, New York
Site Reference ID/Investigator# 48268
New York, New York, United States, 10016
United States, North Carolina
Site Reference ID/Investigator# 50428
Statesville, North Carolina, United States, 28677
United States, Texas
Site Reference ID/Investigator# 48266
San Antonio, Texas, United States, 78215
United States, Virginia
Site Reference ID/Investigator# 50427
Newport News, Virginia, United States, 23602
United States, Washington
Site Reference ID/Investigator# 48265
Seattle, Washington, United States, 98101
United States, Wisconsin
Site Reference ID/Investigator# 50424
Madison, Wisconsin, United States, 53792

Sponsors and Collaborators

Abbott

Investigators

Study Director:

Daniel Cohen, MD

Abbott

More Information

No publications provided by Abbott

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Abbott
ClinicalTrials.gov Identifier:	NCT01306617 History of Changes
Other Study ID Numbers:	M12-746
Study First Received:	February 28, 2011
Last Updated:	November 21, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Virus Diseases
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

Ribavirin
Ritonavir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Anti-HIV Agents
Anti-Retroviral Agents

ClinicalTrials.gov processed this record on May 23, 2013