A Study to Evaluate the Safety and Effect of Co-administration of ABT-450 With Ritonavir (ABT-450/r) and ABT-267 in Adults With Chronic Hepatitis C Virus Infection (PEARL-I)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01685203
First received: September 12, 2012
Last updated: January 28, 2014
Last verified: January 2014
  Purpose

The purpose of this study is to evaluate the safety and effect of co-administration of ABT-450 with ritonavir (ABT-450/r) and ABT-267 in adults with chronic hepatitis C virus infection.


Condition Intervention Phase
Hepatitis C Virus
Drug: ABT-450/r
Drug: ABT-267
Drug: Ribavirin
Phase 2

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 Coadministration of ABT-450 With Ritonavir (ABT-450/r) and ABT-267 in Adults With Chronic Hepatitis C Virus Infection (PEARL-I)

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Percentage of subjects in each treatment group with treatment-emergent adverse events [ Time Frame: up to 30 days following treatment ] [ Designated as safety issue: Yes ]
  • 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:
  • Percentage of subjects in each treatment group with sustained virologic response 24 weeks post-treatment [ Time Frame: 24 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

  • Percentage of subjects in each treatment group with on-treatment virologic failure. [ Time Frame: During treatment (up to 24 weeks) ] [ Designated as safety issue: No ]
    Hepatitis C virus ribonucleic acid greater than lower limit of quantification

  • Percentage of subjects in each treatment group with post-treatment relapse. [ Time Frame: After last dose until 12 weeks post-treatment ] [ Designated as safety issue: No ]
    Hepatitis C virus ribonucleic acid greater than lower limit of quantification


Estimated Enrollment: 320
Study Start Date: August 2012
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
ABT-450/r + ABT-267 dosed in combination in adult treatment naive HCV genotype 4 subjects
Drug: ABT-450/r
tablet (ABT-450), capsule (ritonavir)
Drug: ABT-267
tablet
Experimental: Arm 2
ABT-450/r + ABT-267 dosed in combination in adult treatment naive HCV genotype 1b subjects
Drug: ABT-450/r
tablet (ABT-450), capsule (ritonavir)
Drug: ABT-267
tablet
Experimental: Arm 3
ABT-450/r + ABT-267 dosed in combination in adult pegIFN and RBV null responder HCV genotype 1b subjects
Drug: ABT-450/r
tablet (ABT-450), capsule (ritonavir)
Drug: ABT-267
tablet
Experimental: Arm 4
ABT-450/r + ABT-267 + Ribavirin dosed in combination in adult treatment naive HCV genotype 4 subjects
Drug: ABT-450/r
tablet (ABT-450), capsule (ritonavir)
Drug: ABT-267
tablet
Drug: Ribavirin
Tablet
Experimental: Arm 6
ABT-450/r + ABT-267 + Ribavirin dosed in combination in adult pegIFN and RBV treatment experienced HCV genotype 4 subjects
Drug: ABT-450/r
tablet (ABT-450), capsule (ritonavir)
Drug: ABT-267
tablet
Drug: Ribavirin
Tablet
Experimental: Arm 7
ABT-450/r + ABT-267 dosed in combination in adult treatment naïve HCV genotype 1b subjects with compensated cirrhosis
Drug: ABT-450/r
tablet (ABT-450), capsule (ritonavir)
Drug: ABT-267
tablet
Experimental: Arm 8
ABT-450/r + ABT-267 dosed in combination in adult pegIFN and RBV treatment experienced HCV genotype 1b subjects with compensated cirrhosis
Drug: ABT-450/r
tablet (ABT-450), capsule (ritonavir)
Drug: ABT-267
tablet

  Eligibility

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

Inclusion Criteria:

  • Subjects must meet one of the following:

    • Treatment-naive: Subject has never received antiviral treatment for hepatitis C infection OR
    • Treatment Experienced (Prior null responders, Partial responders or Relapsers to pegIFN/RBV);
  • Body mass index (BMI) is ≥ 18 to < 38 kg/m2.
  • Chronic HCV genotype 1b infection/with or without cirrhosis or HCV genotype 4 infection/without cirrhosis for at least 6 months prior to study screening.
  • Subject has plasma HCV RNA level > 10,000 IU/mL at Screening

Exclusion Criteria:

  • History of severe, life-threatening or other significant sensitivity to any drug.
  • Females who are pregnant or breastfeeding.
  • Recent history of drug or alcohol abuse that could preclude adherence to the protocol.
  • Positive test result for hepatitis B surface antigen or anti-Human Immunodeficiency Virus (HIV) antibodies.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01685203

  Show 47 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Tolga Baykal, MD AbbVie
  More Information

No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01685203     History of Changes
Other Study ID Numbers: M13-393, 2011-005762-38
Study First Received: September 12, 2012
Last Updated: January 28, 2014
Health Authority: Hungary: National Institute of Pharmacy
Italy: The Italian Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Medicines Agency
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Turkey: Ministry of Health
United States: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by AbbVie:
Hepatitis C Virus
Ribavirin-Free
Hepatitis C Genotype 1
Hepatitis C
Interferon-Free
Chronic Hepatitis C
Compensated cirrhosis
Hepatitis C Genotype 4

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Virus Diseases
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
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 16, 2014