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: July 22, 2014
Last verified: July 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
Primary Completion Date: June 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
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: 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: July 22, 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
Virus Diseases
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Ritonavir
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Anti-HIV Agents
Anti-Retroviral Agents

ClinicalTrials.gov processed this record on October 02, 2014