A Randomized Study to Evaluate the Safety, Tolerability and Antiviral Activity of ABT-450, ABT-333 and ABT-072 (Champion2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01074008
First received: February 22, 2010
Last updated: February 6, 2013
Last verified: January 2013
  Purpose

A 12-week study of combination direct-acting antiviral agent (DAA) and pegIFN/RBV in subjects with chronic HCV.


Condition Intervention Phase
Hepatitis C
HCV
Chronic Hepatitis C
Genotype 1
Drug: ABT-450
Drug: ABT-072
Drug: ABT-333
Drug: ritonavir
Drug: pegIFN
Drug: ribavirin
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Blinded, Randomized, Placebo-controlled, Dose Ranging Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Multiple Doses of ABT-450 With Ritonavir (ABT-450/r), ABT-333 or ABT-072 Each Administered Alone and in Combination With Peginterferon α-2a and Ribavirin (PegIFN/RBV) in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Efficacy endpoint of maximum decrease from baseline in log10 HCV RNA levels during ABT-450/r, ABT-333 or ABT-072 monotherapy treatment [ Time Frame: Baseline to Study Day 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of subjects with RVR (HCV RNA level < 25 IU/mL) at Study Week 4. [ Time Frame: Baseline to Study Week 4 ] [ Designated as safety issue: No ]
  • Percentage of subjects with partial EVR (HCV RNA decrease > 2 log10 IU/mL) or with complete EVR (HCV RNA level < 25 IU/mL) at Study Week 12 or the last treatment visit with DAA. [ Time Frame: Baseline to Study Week 12 ] [ Designated as safety issue: No ]

Enrollment: 74
Study Start Date: March 2010
Study Completion Date: January 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 8. ABT-333 Groups 7-8
ABT-333 or matching placebo monotherapy for 3 days followed by the addition of pegIFN/RBV for a total of 12 weeks of combination treatment. Followed by 36 weeks of pegIFN/RBV alone.
Drug: ABT-333
ABT-333 active
Drug: pegIFN
pegylated interferon-alpha (syringe)
Other Name: Pegasys
Drug: ribavirin
ribavirin (tablet)
Other: Placebo
Placebo
Experimental: 7. ABT-333 Groups 7-8
ABT-333 or matching placebo monotherapy for 3 days followed by the addition of pegIFN/RBV for a total of 12 weeks of combination treatment. Followed by 36 weeks of pegIFN/RBV alone.
Drug: ABT-333
ABT-333 active
Drug: pegIFN
pegylated interferon-alpha (syringe)
Other Name: Pegasys
Drug: ribavirin
ribavirin (tablet)
Other: Placebo
Placebo
Experimental: 6. ABT-072 Groups 4-6
ABT-072 or matching placebo monotherapy for 3 days followed by the addition of pegIFN/RBV for a total of 12 weeks of combination treatment. Followed by 36 weeks of pegIFN/RBV alone.
Drug: ABT-072
ABT-072 active
Drug: pegIFN
pegylated interferon-alpha (syringe)
Other Name: Pegasys
Drug: ribavirin
ribavirin (tablet)
Other: Placebo
Placebo
Experimental: 5. ABT-072 Groups 4-6
ABT-072 or matching placebo monotherapy for 3 days followed by the addition of pegIFN/RBV for a total of 12 weeks of combination treatment. Followed by 36 weeks of pegIFN/RBV alone.
Drug: ABT-072
ABT-072 active
Drug: pegIFN
pegylated interferon-alpha (syringe)
Other Name: Pegasys
Drug: ribavirin
ribavirin (tablet)
Other: Placebo
Placebo
Experimental: 4. ABT-072 Groups 4-6
ABT-072 or matching placebo monotherapy for 3 days followed by the addition of pegIFN/RBV for a total of 12 weeks of combination treatment. Followed by 36 weeks of pegIFN/RBV alone
Drug: ABT-072
ABT-072 active
Drug: pegIFN
pegylated interferon-alpha (syringe)
Other Name: Pegasys
Drug: ribavirin
ribavirin (tablet)
Other: Placebo
Placebo
Experimental: 1. ABT-450/r Groups 1-3
ABT-450/r or matching placebo monotherapy for 3 days followed by the addition of pegIFN/RBV for a total of 12 weeks of combination treatment. Followed by 36 weeks of pegIFN/RBV alone. Subjects randomized to an ABT-450/r treatment group who achieve RVR and have HCV RNA < 25 IU/mL at all subsequent visits will be eligible to stop SOC on or after Study Week 24.
Drug: ABT-450
ABT-450 active
Drug: ritonavir
ritonavir active
Other Name: ABT-538, Norvir
Drug: pegIFN
pegylated interferon-alpha (syringe)
Other Name: Pegasys
Drug: ribavirin
ribavirin (tablet)
Other: Placebo
Placebo
Experimental: 2. ABT-450/r Groups 1-3
ABT-450/r or matching placebo monotherapy for 3 days followed by the addition of pegIFN/RBV for a total of 12 weeks of combination treatment. Followed by 36 weeks of pegIFN/RBV alone. Subjects randomized to an ABT-450/r treatment group who achieve RVR and have HCV RNA < 25 IU/mL at all subsequent visits will be eligible to stop SOC on or after Study Week 24.
Drug: ABT-450
ABT-450 active
Drug: ritonavir
ritonavir active
Other Name: ABT-538, Norvir
Drug: pegIFN
pegylated interferon-alpha (syringe)
Other Name: Pegasys
Drug: ribavirin
ribavirin (tablet)
Other: Placebo
Placebo
Experimental: 3. ABT-450/r Groups 1-3
ABT-450/r or matching placebo monotherapy for 3 days followed by the addition of pegIFN/RBV for a total of 12 weeks of combination treatment. Followed by 36 weeks of pegIFN/RBV alone. Subjects randomized to an ABT-450/r treatment group who achieve RVR and have HCV RNA < 25 IU/mL at all subsequent visits will be eligible to stop SOC on or after Study Week 24.
Drug: ABT-450
ABT-450 active
Drug: ritonavir
ritonavir active
Other Name: ABT-538, Norvir
Drug: pegIFN
pegylated interferon-alpha (syringe)
Other Name: Pegasys
Drug: ribavirin
ribavirin (tablet)
Other: Placebo
Placebo

  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 (HCV RNA level greater than or equal to 100,000 IU/mL) at screening.
  • 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 HCV.
  • Treatment naïve male or female between the ages of 18 and 65.
  • Females must be post-menopausal for more than 2 years or surgically sterile.
  • Negative screen for drugs and alcohol.
  • Negative HBsAg and anti-HIV Ab.
  • No use of CYP3A and CYP2C8 enzyme inducers or inhibitors within 1 month of dosing.
  • Be in a condition of general good health, as perceived by the investigator, other than HCV infection.

Exclusion Criteria:

  • Significant sensitivity to any drug.
  • Use of herbal supplements within 2 weeks prior to study drug dosing. History of major depression within 2 years.
  • Prior treatment with any investigational or commercially available anti-HCV agents.
  • Abnormal laboratory tests.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01074008

  Show 26 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Daniel Cohen AbbVie
  More Information

No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01074008     History of Changes
Other Study ID Numbers: M11-602
Study First Received: February 22, 2010
Last Updated: February 6, 2013
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 15, 2014