A Study to Evaluate the Safety and Effect of ABT-450, Ritonavir and ABT-267 (ABT-450/r/ABT-267) and ABT-333 Coadministered With Ribavirin (RBV) in Hepatitis C Virus (HCV) Genotype 1-infected Adults With Compensated Cirrhosis (TURQUOISE-II)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01704755
First received: September 28, 2012
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

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 coadministered with ribavirin (RBV) in HCV genotype 1-infected adults with compensated cirrhosis.


Condition Intervention Phase
Chronic Hepatitis C
Compensated Cirrhosis
Hepatitis C Virus
Drug: ABT-450/r/ABT-267
Drug: ABT-333
Drug: Ribavirin (RBV)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Coadministered With Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (TURQUOISE-II)

Resource links provided by NLM:


Further study details as provided by AbbVie:

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


Secondary Outcome Measures:
  • The percentage of subjects with sustained virologic response 12 weeks post-treatment in the 24-week arm compared to the 12-week arm [ Time Frame: 12 weeks after last dose of study drug ] [ Designated as safety issue: No ]
    Hepatitis C virus ribonucleic acid less than the lower limit of quantification

  • The percentage of subjects in each arm with on-treatment virologic failure during the Treatment Period [ Time Frame: up to 12 or 24 weeks ] [ Designated as safety issue: No ]
    Percentage of subjects with confirmed quantifiable Hepatitis C virus ribonucleic acid among subjects with previous unquantifiable Hepatitis C virus ribonucleic acid during treatment

  • The percentage of subjects in each arm with post-treatment relapse [ Time Frame: within 12 weeks after the last dose of study drug ] [ Designated as safety issue: No ]
    The percentage of subjects with confirmed quantifiable Hepatitis C virus ribonucleic acid among subjects with unquantifiable Hepatitis C virus ribonucleic acid at the end of treatment


Estimated Enrollment: 380
Study Start Date: October 2012
Estimated Study Completion Date: September 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A
ABT-450/r/ABT-267 and ABT-333 coadministered with ribavirin (RBV) for 12 weeks
Drug: ABT-450/r/ABT-267
tablet
Drug: ABT-333
tablet
Drug: Ribavirin (RBV)
tablet
Experimental: Arm B
ABT-450/r/ABT-267 and ABT-333 coadministered with ribavirin (RBV) for 24 weeks
Drug: ABT-450/r/ABT-267
tablet
Drug: ABT-333
tablet
Drug: Ribavirin (RBV)
tablet

  Eligibility

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

Inclusion Criteria:

  • Male or female and age is between 18 and 70 years, inclusive, at time of Screening.
  • Chronic HCV-infection prior to study enrollment.
  • Screening laboratory result indicating HCV genotype 1-infection.
  • Compensated cirrhosis defined as a Child-Pugh Score of less than or equal to 6 at Screening
  • Subject has plasma HCV RNA level greater than 10,000 IU/mL at Screening.

Exclusion Criteria:

  • Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human Immunodeficiency virus antibody (HIV Ab) at screening.
  • Prior therapy with direct acting antiviral agents for the treatment of HCV, including telaprevir and boceprevir.
  • Any current or past clinical evidence of Child-Pugh B or C Classification or clinical history of liver decompensation including ascites (noted on physical exam), variceal bleeding or hepatic encephalopathy.
  • A positive screening ultrasound for hepatocellular carcinoma (HCC) confirmed with a subsequent CT Scan or MRI during the screening period.
  • Any cause of liver disease other than chronic HCV-infection, including but not limited to the following:
  • Hemochromatosis
  • Alpha-1 antitrypsin deficiency
  • Wilson's disease
  • Autoimmune hepatitis
  • Alcoholic liver disease
  • Drug-related liver disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01704755

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

No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01704755     History of Changes
Other Study ID Numbers: M13-099, 2012-003088-23
Study First Received: September 28, 2012
Last Updated: April 8, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by AbbVie:
Cirrhosis
Hepatitis C
Child Pugh A
Compensated Cirrhosis
Hepatitis C Genotype 1
Cirrhotic
Chronic Hepatitis C
Interferon-Free
Hepatitis C Virus

Additional relevant MeSH terms:
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Hepatitis A
Hepatitis, Chronic
Liver Cirrhosis
Fibrosis
Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Pathologic Processes
Ribavirin
Ritonavir
Antiviral Agents
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