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: September 16, 2014
Last verified: September 2014
  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:


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 sustained virologic response [ 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 in genotype 1a subjects

  • Percentage of subjects with sustained virologic response [ 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 in genotype 1b subjects


Estimated Enrollment: 600
Study Start Date: November 2012
Estimated Study Completion Date: September 2014
Primary Completion Date: October 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 efficacy 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:

  • 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
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: NCT01716585

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

No publications provided by AbbVie

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: September 16, 2014
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:
Infection
Communicable Diseases
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 01, 2014