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
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: 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 August 19, 2014