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: May 30, 2014
Last verified: May 2014
  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: 61
Study Start Date: October 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, 71105
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
Annandale, Virginia, United States, 22003
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: May 30, 2014
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 C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Ritonavir
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Anti-HIV Agents
Anti-Retroviral Agents

ClinicalTrials.gov processed this record on September 18, 2014