A Study to Evaluate Chronic Hepatitis C Infection

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01716585
First received: October 18, 2012
Last updated: December 23, 2014
Last verified: December 2014
  Purpose

The purpose of this study is to evaluate the safety and efficacy of ABT-450, ritonavir and ABT-267 (ABT-450/r/ABT-267; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) co-administered with ribavirin (RBV) in hepatitis C virus genotype 1 infected treatment-naïve adults.


Condition Intervention Phase
Chronic Hepatitis C Infection
Drug: ABT/450/r/ABT-267
Drug: ABT-333
Drug: Ribavirin
Drug: Placebo for ABT-450/r/ABT-267
Drug: Placebo for ABT- 333
Drug: Placebo for ribavirin
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 Participants With Sustained Virologic Response 12 Weeks After Treatment [ Time Frame: 12 weeks after the last actual dose of active study drug ] [ Designated as safety issue: No ]
    The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.


Secondary Outcome Measures:
  • Percentage of Participants With Normalization of Alanine Aminotransferase (ALT) at Final Treatment Visit During the Double-Blind Treatment Period [ Time Frame: At 12 weeks ] [ Designated as safety issue: Yes ]
    Normalization is defined as alanine aminotransferase less than or equal to the upper limit of normal (ULN) at final treatment visit for participants with alanine aminotransferase greater than ULN at baseline.

  • Percentage of HCV Genotype 1a-infected Participants With Sustained Virologic Response 12 Weeks After Treatment [ Time Frame: 12 weeks after the last actual dose of active study drug ] [ Designated as safety issue: No ]
    The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.

  • Percentage of HCV Genotype 1b-infected Participants With Sustained Virologic Response 12 Weeks After Treatment [ Time Frame: 12 weeks after the last actual dose of active study drug ] [ Designated as safety issue: No ]
    The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.

  • Percentage of Participants With On-treatment Virologic Failure During the Double-blind Treatment Period: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm [ Time Frame: 12 weeks after the last actual dose of active study drug ] [ Designated as safety issue: No ]
    Virologic failure was defined as rebound (hepatitis C virus ribonucleic acid [HCV RNA] ≥ lower limit of quantification [LLOQ] after HCV RNA < LLOQ or increase in HCV RNA of at least 1 log10 IU/mL) or failure to suppress (all on-treatment values of plasma HCV RNA ≥ LLOQ with at least 36 days of treatment) during treatment.

  • Percentage of Participants With Virologic Relapse After Treatment: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm [ Time Frame: Within 12 weeks post-treatment ] [ Designated as safety issue: No ]
    Participants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma hepatitis C virus ribonucleic acid (HCV RNA) greater than or equal to the lower limit of quantification (≥ LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA < LLOQ at the end of treatment.


Enrollment: 636
Study Start Date: November 2012
Study Completion Date: October 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ABT-450/r/ABT-267 and ABT-333, plus RBV
Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
Drug: ABT/450/r/ABT-267
Tablet; ABT-450 coformulated with ritonavir and ABT-267
Other Name: ABT-267 also known as ombitasvir
Drug: ABT-333
Tablet
Other Name: dasabuvir
Drug: Ribavirin
Capsule (double-blind treatment period), tablet (open-label treatment period)
Experimental: Placebo Followed by ABT-450/r/ABT-267 and ABT-333, plus RBV
Double-blind placebo for 12 weeks, followed by open-label ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
Drug: ABT/450/r/ABT-267
Tablet; ABT-450 coformulated with ritonavir and ABT-267
Other Name: ABT-267 also known as ombitasvir
Drug: ABT-333
Tablet
Other Name: dasabuvir
Drug: Ribavirin
Capsule (double-blind treatment period), tablet (open-label treatment period)
Drug: Placebo for ABT-450/r/ABT-267
Tablet
Drug: Placebo for ABT- 333
Tablet
Drug: Placebo for ribavirin
Capsule

Detailed Description:

Safety and efficacy data through 4 November 2013 are included in this interim analysis, conducted after participants in the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment arm completed the post-treatment week 12 visit or discontinued from study and Double-blind Placebo arm participants completed 12 weeks open-label treatment or discontinued from study drug.

  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 at least 2 years or surgically sterile or practicing specific forms of birth control
  • Chronic hepatitis C, genotype 1-infection and 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
  • Certain predefined abnormal laboratory tests
  • Positive hepatitis B surface antigen or 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

Additional 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
Results First Received: December 23, 2014
Last Updated: December 23, 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:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Infection
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Ribavirin
Anti-Infective Agents
Antimetabolites
Antiviral Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on May 27, 2015