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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01306617
First received: February 28, 2011
Last updated: November 21, 2012
Last verified: November 2012
  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:


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
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: 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):
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 C
Hepatitis C, Chronic
Hepatitis, Chronic
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Ribavirin
Ritonavir
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antimetabolites
Antiviral Agents
Enzyme Inhibitors
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014