A Study to Evaluate Chronic Hepatitis C Infection in Treatment Experienced Adults

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01715415
First received: October 25, 2012
Last updated: April 8, 2014
Last verified: April 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)
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 ABT450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co-administered With Ribavirin (RBV) in Treatment-Experienced Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (SAPPHIRE-II)

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 final treatment visit ] [ 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 in the active treatment group with virologic failure during treatment [ Time Frame: During treatment ] [ Designated as safety issue: No ]
    Hepatitis C virus (HCV) ribonucleic acid (RNA) confirmed greater than or equal to the lower limit of quantification, after HCV RNA less than the lower limit of quantification or HCV RNA confirmed greater than or equal to the lower limit of quantification at the end of treatment.

  • Percentage of subjects in the active treatment group with post-treatment relapse [ Time Frame: Within 12 weeks post treatment ] [ Designated as safety issue: No ]
    Hepatitis C Virus (HCV) ribonucleic acid (RNA) confirmed greater than or equal to the lower limit of quantification between the end of treatment and 12 weeks post treatment among subjects completing treatment and with HCV RNA less than the lower limit of quantification at the end of treatment

  • Percentage of HCV genotype 1a subjects with SVR12 [ Time Frame: Within 12 weeks post treatment ] [ Designated as safety issue: No ]
    The percentage of genotype 1a infected subjects treated in the active treatment group that achieve SVR12

  • Percentage of HCV genotype 1b subjects with SVR12 [ Time Frame: Within 12 weeks post treatment ] [ Designated as safety issue: No ]
    The percentage of genotype 1b infected subjects treated in the active treatment group that achieve SVR12


Estimated Enrollment: 400
Study Start Date: November 2012
Estimated Study Completion Date: October 2014
Primary Completion Date: November 2013 (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
Placebo for ABT-450/r/ABT-267 and placebo for ABT-333 coadministered with placebo for ribavirin (RBV) for 12 weeks followed by 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

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-experienced adults (SAPPHIRE-II).

  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).
  • Failed previous treatment with pegIFN and RBV.
  • 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: NCT01715415

  Show 79 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Tolga Baykal, 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: NCT01715415     History of Changes
Other Study ID Numbers: M13-098, 2012-002035-29
Study First Received: October 25, 2012
Last Updated: April 8, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Australia: Department of Health and Ageing Therapeutic Goods Administration
Germany: Federal Institute for Drugs and Medical Devices
Czech Republic: State Institute for Drug Control
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Denmark: Danish Medicines Agency
Italy: Ministry of Health
Mexico: Ministry of Health
Netherlands: Medicines Evaluation Board (MEB)
Portugal: National Pharmacy and Medicines Institute
Turkey: Ministry of Health
Russia: Ministry of Health of the Russian Federation
Ireland: Irish Medicines Board

Keywords provided by AbbVie:
Hepatitis C
Treatment-Experienced
Null responder
Partial Responder
Chronic Hepatitis
Hepatitis C Genotype 1
Interferon-Free
Hepatitis C Virus
Relapser
Non responder

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Infection
Communicable Diseases
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
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 16, 2014