Trial record 4 of 1405 for:    "Hepatitis C"

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
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 C
Hepatitis C, Chronic
Hepatitis
Hepatitis A
Hepatitis, Chronic
Virus Diseases
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 14, 2014