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
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: 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 July 23, 2014