A Study to Evaluate ABT-450 With Ritonavir (ABT-450/r) When Given Together With ABT-267 and With and Without Ribavirin (RBV) in Treatment-Naïve Subjects With Genotype 1, 2 or 3 Chronic Hepatitis C Virus (HCV) - Full Text View

Purpose

A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of ABT-450 with Ritonavir (ABT-450/r) when given together with ABT-267 and with and without Ribavirin (RBV) in Treatment-Naïve Subjects with Genotype 1, 2 or 3 Chronic Hepatitis C Virus (HCV) Infection.

Condition	Intervention	Phase
Hepatitis C Virus	Drug: ABT-450/r Drug: ABT-267 Drug: ribavirin	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open-Label, Sequential Arm, Multicenter Study to Evaluate the Antiviral Activity, Safety and Pharmacokinetics of ABT-450 With Ritonavir (ABT-450/r) Dosed in Combination With ABT-267 With and Without Ribavirin (RBV) in Treatment-Naïve Subjects With Genotype 1, 2 or 3 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 Hepatitis A Vaccines

U.S. FDA Resources

Further study details as provided by AbbVie:

Primary Outcome Measures:

Assess the safety and antiviral activity (proportion of subjects with hepatitis C ribonucleic acid (HCV RNA) < lower limit of quantitation (LLOQ) [ Time Frame: Week 4 and Week 12 (eRVR) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assess the percentage of subjects with SVR12 (HCV RNA < LLOQ 12 Weeks post-treatment) [ Time Frame: Post-Treatment Week 12 ] [ Designated as safety issue: No ]
Assess the percentage of subjects with SVR24 (HCV RNA < LLOQ 24 Weeks post-treatment) [ Time Frame: Post-Treatment Week 24 ] [ Designated as safety issue: No ]
Assess the percentage of subjects with HCV RNA < 1000 IU/mL [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
Assess the percentage of subjects with HCV RNA < LLOQ [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
Assess the time to failure to suppress, rebound or relapse (confirmed increase of at least 1 log10 IU/mL above nadir or confirmed HCV RNA > LLOQ for subjects who previously achieved HCV RNA < LLOQ) [ Time Frame: Day 1 to Post Treatment Week 24 ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	September 2011
Estimated Study Completion Date:	May 2013
Estimated Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm 1 ABT-450/r + ABT-267 + RBV dosed in combination in treatment naive subjects	Drug: ABT-450/r tablet (ABT-450), capsule (ritonavir) Drug: ABT-267 tablet Drug: ribavirin tablet
Experimental: Arm 2 ABT-450/r + ABT-267 dosed in combination in treatment naive subjects	Drug: ABT-450/r tablet (ABT-450), capsule (ritonavir) Drug: ABT-267 tablet

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 (Genotype 1, 2 or 3)
Male or female 18-65 years old, inclusive

Exclusion Criteria:

Positive drug screen
Previous use of anti-HCV agents
History of cardiac disease
History of uncontrolled diabetes or diabetes requiring insulin
Abnormal laboratory results

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01458535

Locations

United States, Alabama
Site Reference ID/Investigator# 61005
Birmingham, Alabama, United States, 35215
Site Reference ID/Investigator# 60995
Dothan, Alabama, United States, 36305
United States, California
Site Reference ID/Investigator# 62762
Los Angeles, California, United States, 90048
Site Reference ID/Investigator# 60987
San Diego, California, United States, 92123
United States, Colorado
Site Reference ID/Investigator# 60991
Aurora, Colorado, United States, 80045
United States, Florida
Site Reference ID/Investigator# 60994
Bradenton, Florida, United States, 34209
United States, Georgia
Site Reference ID/Investigator# 61002
Marietta, Georgia, United States, 30060
United States, Louisiana
Site Reference ID/Investigator# 60984
Shreveport, Louisiana, United States, 71103
United States, Missouri
Site Reference ID/Investigator# 60992
Kansas City, Missouri, United States, 64134
Site Reference ID/Investigator# 60985
St. Louis, Missouri, United States, 63104
United States, Ohio
Site Reference ID/Investigator# 61007
Cincinnati, Ohio, United States, 45242
United States, Texas
Site Reference ID/Investigator# 60999
San Antonio, Texas, United States, 78215
United States, Virginia
Site Reference ID/Investigator# 61001
Fairfax, Virginia, United States, 22031
United States, Washington
Site Reference ID/Investigator# 60997
Seattle, Washington, United States, 98101
Puerto Rico
Site Reference ID/Investigator# 60982
San Juan, Puerto Rico, 00927

Sponsors and Collaborators

AbbVie (prior sponsor, Abbott)

Investigators

Study Director:

Andrew Campbell, MD

AbbVie

More Information

No publications provided

Responsible Party:	AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:	NCT01458535 History of Changes
Other Study ID Numbers:	M12-998
Study First Received:	September 23, 2011
Last Updated:	March 15, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by AbbVie:

Genotype 1
Genotype 3
Hepatitis C
Genotype 2

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 June 18, 2013

A Study to Evaluate ABT-450 With Ritonavir (ABT-450/r) When Given Together With ABT-267 and With and Without Ribavirin (RBV) in Treatment-Naïve Subjects With Genotype 1, 2 or 3 Chronic Hepatitis C Virus (HCV) (Navigator)