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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01458535
First received: September 23, 2011
Last updated: June 21, 2013
Last verified: June 2013
  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:


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 ]

Enrollment: 60
Study Start Date: September 2011
Study Completion Date: May 2013
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, 64131
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: June 21, 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 April 15, 2014