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A Study to Evaluate Chronic Hepatitis C Infection

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01716585
First received: October 18, 2012
Last updated: May 17, 2013
Last verified: May 2013
History of Changes
  Purpose

A study to evaluate chronic hepatitis C infection.


Condition Intervention Phase
Chronic Hepatitis C Infection
 Drug: ABT/450/r/ABT-267
Drug: ABT-333
Drug: Ribavirin (RBV)
Drug: Placebo for ABT-450/r/ABT-267
Drug: Placebo for ABT- 333
Drug: Placebo for Ribavirin (RBV)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co-administered With Ribavirin (RBV) in Treatment-Naïve Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (SAPPHIRE-I)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Percentage of subjects with sustained virologic response 12 weeks post-treatment [ Time Frame: 12 weeks after the last actual dose of active study drug ] [ Designated as safety issue: No ]
    Hepatitis C virus ribonucleic acid less than the lower limit of quantification


Secondary Outcome Measures:
  • Percentage of subjects with alanine aminotransferase normalization [ Time Frame: At 12 weeks ] [ Designated as safety issue: Yes ]
    Alanine aminotransferase less than or equal to the upper limit of normal at final treatment visit for subjects with alanine aminotransferase greater than the upper limit of normal at baseline.

  • Percentage of subjects with sustaine virologic response [ Time Frame: At 12 weeks ] [ Designated as safety issue: No ]
    Hepatitis C virus ribonucleic acid less than the lower limit of quantification in genotype 1a subjects

  • Percentage of subjects with sustained virologic response [ Time Frame: At 12 weeks ] [ Designated as safety issue: No ]
    hepatitis C virus ribonucleic acid less than the lower limit of quantification in genotype 1a subjects


Estimated Enrollment: 600
Study Start Date: April 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A
ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD + ABT-333 250 mg BID + RBV BID for 12 weeks
 Drug: ABT/450/r/ABT-267
tablet
Drug: ABT-333
tablet
Drug: Ribavirin (RBV)
tablet
Experimental: Arm B
Placebos for (ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD + ABT 333 250 mg BID + RBV BID) for 12 weeks followed by ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD + ABT-333 250 mg BID + RBV BID for 12 weeks
 Drug: ABT/450/r/ABT-267
tablet
Drug: ABT-333
tablet
Drug: Ribavirin (RBV)
tablet
Drug: Placebo for ABT-450/r/ABT-267
tablet
Drug: Placebo for ABT- 333
tablet
Drug: Placebo for Ribavirin (RBV)
capsule

Detailed Description:

The purpose of this study is to evaluate the safety and effect of ABT-450, ritonavir and ABT-267 (ABT-450/r/ABT-267) and ABT-333 co-administered with ribavirin in hepatitis C virus genotype 1 infected treatment-naïve adults (SAPPHIRE-I).

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males or female between 18 and 70 years old, inclusive
  • Females must be post-menopausal for more than 2 years or surgically sterile or practicing specific forms of birth control
  • Chronic hepatitis C, genotype 1-infection (HCV RNA level greater than 10,000 IU/mL at screening)
  • Subject has never received antiviral treatment for hepatitis C infection
  • No evidence of liver cirrhosis

Exclusion Criteria:

  • Positive screen for drugs or alcohol
  • Significant sensitivity to any drug
  • Use of contraindicated medications within 2 weeks of dosing
  • Abnormal laboratory tests
  • Positive hepatitis B surface antigen and anti-Human Immunodeficiency Virus Antibody
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01716585

  Show 79 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Eoin Coakley, MD AbbVie
  More Information

No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01716585     History of Changes
Other Study ID Numbers: M11-646, 2012-002019-25
Study First Received: October 18, 2012
Last Updated: May 17, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by AbbVie:
Hepatitis C Virus
Hepatitis C Genotype 1
Hepatitis C
 Treatment-Naïve
Interferon-Free
Chronic Hepatitis C

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
Ribavirin
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013