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A Study to Evaluate Chronic Hepatitis C Infection in Adults With Genotype 1a Infection (PEARL-IV)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT01833533
First received: February 27, 2013
Last updated: September 16, 2014
Last verified: September 2014
  Purpose

This is a study to evaluate chronic hepatitis C infection in adults with genotype 1a infection.


Condition Intervention Phase
Chronic Hepatitis C Infection
Drug: ABT-450/r/ABT-267
Drug: ABT-333
Drug: Ribavirin
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, Controlled Study to Evaluate the Efficacy and Safety of the Combination of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With and Without Ribavirin (RBV) in Treatment-Naïve Adults With Genotype 1a Chronic Hepatitis C Virus (HCV) INfection (PEARL-IV)

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Percentage of subjects in each treatment group with sustained virologic response 12 weeks post-treatment [ Time Frame: 12 weeks after the 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:
  • Changes in hemoglobin laboratory values during treatment [ Time Frame: Day 1 through Week 12 ] [ Designated as safety issue: Yes ]
    Hemoglobin laboratory values below the the lower limit of normal

  • Percentage of subjects with virologic failure during treatment [ Time Frame: Up to Week 12 ] [ Designated as safety issue: No ]
    Hepatitis C virus ribonucleic acid greater than the lower limit of quantification

  • Percentage of subjects with virologic relapse after treatment [ Time Frame: Up to post-treatment Week 48 ] [ Designated as safety issue: No ]
    Hepatitis C virus ribonucleic acid greater than the lower limit of quantification


Enrollment: 305
Study Start Date: March 2013
Study Completion Date: September 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A (DAA + RBV)
ABT-450/r/ABT-267 150 mg/100 mg/ 25 mg once a day + ABT-333 250 mg twice a day + ribavirin twice a day for 12 weeks
Drug: ABT-450/r/ABT-267
Tablet
Drug: ABT-333
Tablet
Drug: Ribavirin
Tablet
Experimental: Arm B (DAA + placebo for RBV)
ABT-450/r/ABT-267 150 mg/100 mg/ 25 mg once a day + ABT-333 250 mg twice a day + placebo for ribavirin twice a day for 12 weeks
Drug: ABT-450/r/ABT-267
Tablet
Drug: ABT-333
Tablet
Drug: Placebo for Ribavirin
Tablet

Detailed Description:

The purpose of this study is to evaluate the safety and effect of ABT-450, ritonavir and ABT-267 (ABT-450/r/ABT-267) and ABT-333 with and without ribavirin in hepatitis C virus genotype 1a-infected treatment-naïve adults (PEARL-IV).

  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 1a-infection (HCV RNA level greater than or equal to 10,000 IU/mL at screening)
  • Subject has never received antiviral treatment for hepatitis C infection
  • 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: NCT01833533

  Hide Study Locations
Locations
United States, Alabama
Site Reference ID/Investigator# 96662
Birmingham, Alabama, United States, 35294
United States, California
Site Reference ID/Investigator# 95805
Coronado, California, United States, 92118
Site Reference ID/Investigator# 96655
Los Angeles, California, United States, 90036
Site Reference ID/Investigator# 96661
Newport Beach, California, United States, 92663
Site Reference ID/Investigator# 95943
San Bernardino, California, United States, 92404
Site Reference ID/Investigator# 96697
San Diego, California, United States, 92123
Site Reference ID/Investigator# 95938
San Diego, California, United States, 92120
Site Reference ID/Investigator# 95946
San Diego, California, United States, 92120
Site Reference ID/Investigator# 95947
San Diego, California, United States, 92120
Site Reference ID/Investigator# 95808
San Diego, California, United States, 92103
Site Reference ID/Investigator# 96376
San Francisco, California, United States, 94115
Site Reference ID/Investigator# 95804
San Francisco, California, United States, 94109
Site Reference ID/Investigator# 96395
San Francisco, California, United States, 94118
United States, Florida
Site Reference ID/Investigator# 96304
DeLand, Florida, United States, 32720
Site Reference ID/Investigator# 101215
Fort Pierce, Florida, United States, 34982
Site Reference ID/Investigator# 95949
Tampa, Florida, United States, 33606
Site Reference ID/Investigator# 101418
Wellington, Florida, United States, 33414
Site Reference ID/Investigator# 96659
West Palm Beach, Florida, United States, 33401
Site Reference ID/Investigator# 101055
Zephyrhills, Florida, United States, 33542
United States, Georgia
Site Reference ID/Investigator# 96305
Decatur, Georgia, United States, 30033
United States, Hawaii
Site Reference ID/Investigator# 96357
Honolulu, Hawaii, United States, 96813
United States, Louisiana
Site Reference ID/Investigator# 102155
Bastrop, Louisiana, United States, 71220
United States, Minnesota
Site Reference ID/Investigator# 96660
Minneapolis, Minnesota, United States, 55407-3799
United States, Missouri
Site Reference ID/Investigator# 101419
Kansas City, Missouri, United States, 64131
United States, New Jersey
Site Reference ID/Investigator# 97038
Egg Harbor Township, New Jersey, United States, 08234
Site Reference ID/Investigator# 95948
Hillsborough, New Jersey, United States, 08844
United States, New York
Site Reference ID/Investigator# 95802
Manhasset, New York, United States, 11030
United States, North Carolina
Site Reference ID/Investigator# 96947
Charlotte, North Carolina, United States, 28207
Site Reference ID/Investigator# 96657
Wilmington, North Carolina, United States, 28403
United States, Ohio
Site Reference ID/Investigator# 95952
Cincinnati, Ohio, United States, 45219
Site Reference ID/Investigator# 95939
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Site Reference ID/Investigator# 96663
Allentown, Pennsylvania, United States, 18103
United States, Rhode Island
Site Reference ID/Investigator# 95950
Providence, Rhode Island, United States, 02905
United States, Tennessee
Site Reference ID/Investigator# 95809
Germantown, Tennessee, United States, 38138
Site Reference ID/Investigator# 101435
Nashville, Tennessee, United States, 37211
United States, Texas
Site Reference ID/Investigator# 101056
Houston, Texas, United States, 77004
United States, Utah
Site Reference ID/Investigator# 95803
Murray, Utah, United States, 84123
United States, Virginia
Site Reference ID/Investigator# 100715
Annandale, Virginia, United States, 22003
Site Reference ID/Investigator# 95810
Falls Church, Virginia, United States, 22042
United States, Wisconsin
Site Reference ID/Investigator# 100175
Milwaukee, Wisconsin, United States, 53215
Canada
Site Reference ID/Investigator# 97818
Montreal, Canada, H2L 5B1
Site Reference ID/Investigator# 100696
Montreal, Canada, H2L 4P9
Site Reference ID/Investigator# 97817
Ottawa, Canada, K1H 8L6
Site Reference ID/Investigator# 98915
Toronto, Canada, M6H 3M1
Site Reference ID/Investigator# 100435
Vancouver, Canada, V6Z-2K5
Site Reference ID/Investigator# 99875
Vancouver, Canada, V5Z 1H2
United Kingdom
Site Reference ID/Investigator# 101197
Glasgow, United Kingdom, G12 0YN
Site Reference ID/Investigator# 97635
London, United Kingdom, W2 1NY
Site Reference ID/Investigator# 97636
London, United Kingdom, NW3 2QG
Site Reference ID/Investigator# 97637
London, United Kingdom, SW10 9NH
Site Reference ID/Investigator# 97638
London, United Kingdom, SW17 0QT
Site Reference ID/Investigator# 101515
Nottingham, United Kingdom, NG7 2UH
Site Reference ID/Investigator# 97655
Plymouth, United Kingdom, PL6 8DH
Site Reference ID/Investigator# 97639
Portsmouth, United Kingdom, PO6 3LY
Sponsors and Collaborators
AbbVie
Investigators
Study Director: Yan Luo, 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
ClinicalTrials.gov Identifier: NCT01833533     History of Changes
Other Study ID Numbers: M14-002, 2012-005522-29
Study First Received: February 27, 2013
Last Updated: September 16, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Germany: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AbbVie:
Chronic Hepatitis C
Hepatitis C Virus
Hepatitis C Genotype 1a
Hepatitis C
Treatment-Naïve
Interferon-Free

Additional relevant MeSH terms:
Communicable Diseases
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Infection
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Ribavirin
Anti-Infective Agents
Antimetabolites
Antiviral Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014