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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01715415
First received: October 25, 2012
Last updated: October 23, 2015
Last verified: October 2015
  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-experienced adults.

Condition Intervention Phase
Chronic Hepatitis C Infection
Drug: ABT-450/r/ABT-267, 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 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 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: 395
Study Start Date: November 2012
Study Completion Date: October 2014
Primary Completion Date: November 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, ABT-333
Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet
Other Names:
  • ABT-267 also known as ombitasvir
  • ABT-450 also known as paritaprevir
  • ABT-333 also known as dasabuvir
  • Viekira PAK
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, ABT-333
Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet
Other Names:
  • ABT-267 also known as ombitasvir
  • ABT-450 also known as paritaprevir
  • ABT-333 also known as dasabuvir
  • Viekira PAK
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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.
  • Previous treatment failure of peg-interferon and ribavirin (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.
  • 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: NCT01715415

Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Jeff Enejosa, MD AbbVie
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: 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
Results First Received: December 23, 2014
Last Updated: October 23, 2015
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
France: Afssaps - Agence francaise de securite sanitaire des produits de sante (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
Viekira Pak
ombitasvir
ribavirin
ritonavir
paritaprevir
dasabuvir

Additional relevant MeSH terms:
Hepatitis, Chronic
Hepatitis C
Hepatitis
Hepatitis A
Infection
Communicable Diseases
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Enterovirus Infections
Picornaviridae Infections
Ritonavir
Ribavirin
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Antimetabolites

ClinicalTrials.gov processed this record on August 28, 2016