A Pilot Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of ABT-450 With Ritonavir (ABT-450/r) Dosed in Combination With ABT-072 and Ribavirin (RBV)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01221298
First received: October 13, 2010
Last updated: October 18, 2012
Last verified: October 2012
  Purpose

A 12-week study of combination direct-acting antiviral agents (DAAs) and Ribavirin (RBV) in subjects with chronic Hepatitis C Virus (HCV).


Condition Intervention Phase
Hepatitis C
HCV
Chronic Hepatitis C
Hepatitis C Genotype 1
Drug: ABT-450/r
Drug: ABT-072
Drug: ribavirin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Pilot Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of ABT-450 With Ritonavir (ABT-450/r) Dosed in Combination With ABT-072 and Ribavirin (RBV) in Treatment-Naive 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:
  • Percentage of subjects with Hepatitis C Virus Ribonucleic acid suppressed below the lower limit of quantitation [ Time Frame: For a duration of 8 weeks, beginning at Study Week 4 and ending after the completion of Study Week 12 ] [ Designated as safety issue: No ]
    Analysis of the percentage of subjects with Hepatitis C Virus Ribonucleic acid less than the lower limit of quantitation from Study Week 4 through the completion of Study Week 12


Secondary Outcome Measures:
  • Percentage of subjects with HCV RNA less than lower limit of quantitation [ Time Frame: At Study Week 4 ] [ Designated as safety issue: No ]
    Analysis of percentage of subjects with Hepatitis C Virus Ribonucleic acid less than the lower limit of quantitation at Study Week 4

  • The time to relapse after the treatment regimen [ Time Frame: For a duration of 48 weeks beginning after the completion of Study Week 12 and ending after the completion of Post-Study Week 48 ] [ Designated as safety issue: No ]
    Analysis of the time to a confirmed Hepatitis C Virus Ribonucleic acid greater than the lower limit of detection

  • Percentage of subjects with Sustained Viral Response(12) or Sustained Viral Response(24) [ Time Frame: Post-Study Week 12 and Post-Study Week 24 ] [ Designated as safety issue: No ]
    Analysis of the percentage of subjects with Hepatitis C Virus Ribonucleic acid less than the lower limit of detection 12 weeks post Direct Acting Antiviral Agent therapy, or Hepatitis C Virus Ribonucleic acid less than the lower limit of detection 24 weeks post Direct Acting Antiviral Agent therapy


Enrollment: 11
Study Start Date: October 2010
Study Completion Date: April 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
ABT-450/r dosed in combination with ABT-072 and Ribavirin for 12 weeks
Drug: ABT-450/r
tablets (ABT-450); capsules (ritonavir)
Drug: ABT-072
tablets
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, genotype 1 infection (IL28B rs12979860 genotype C/C).
  • Liver biopsy within 3 years with histology consistent with HCV-induced liver damage, with no evidence of cirrhosis or liver pathology due to any cause other than chronic Hepatitis C Virus.
  • Treatment naïve male or female between the ages of 18 and 65.
  • Females must be post-menopausal for at least 2 years or surgically sterile.
  • Be in a condition of general good health, as perceived by the investigator, other than Hepatitis C Virus infection.

Exclusion Criteria

  • Significant sensitivity to any drug.
  • Use of herbal supplements within 2 weeks prior to study drug dosing.
  • Positive screen for drugs and alcohol.
  • Positive Hepatitis surface Antigen and anti-Human Immunodeficiency Virus Antibody.
  • Use of CYP3A, CYP2C8, and OATP1B1 enzyme inducers or inhibitors within 1 month of dosing.
  • Prior treatment with any investigational or commercially available anti-Hepatitis C Virus agents.
  • Abnormal laboratory tests.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01221298

Locations
United States, California
Site Reference ID/Investigator# 41128
Los Angeles, California, United States, 90048
United States, Illinois
Site Reference ID/Investigator# 42262
Chicago, Illinois, United States, 60637
United States, Texas
Site Reference ID/Investigator# 41127
San Antonio, Texas, United States, 78215
United States, Washington
Site Reference ID/Investigator# 43182
Seattle, Washington, United States, 98101
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: NCT01221298     History of Changes
Other Study ID Numbers: M12-267
Study First Received: October 13, 2010
Last Updated: October 18, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Antiviral Agents
Ribavirin
Ritonavir
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 22, 2014