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 - Full Text View

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:

MedlinePlus related topics: Cirrhosis Hepatitis Hepatitis A Hepatitis C

Drug Information available for: Ribavirin Ritonavir Hepatitis A Vaccines

U.S. FDA Resources

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 12 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:	September 2013 (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 5 ABT-450/r + ABT-267 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
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:

Male or female between the age of 18 and 70 years, inclusive, at time of enrollment.
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

Contacts

Contact: Andrew Coates	847-938-1394	andrew.coates@abbvie.com
Contact: Charley Meyer, BS	847-938-6564	charles.e.meyer@abbvie.com

Show 34 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:	May 1, 2013
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 May 22, 2013

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)