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ABT-450 With Ritonavir and ABT-267 and/or ABT-333 With and Without Ribavirin in Genotype 1 Hepatitis C Virus Infected Patients

Information source: AbbVie
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Hepatitis C; Hepatitis C (HCV); Hepatitis C Genotype 1

Intervention: ABT-450 (Drug); ABT-333 (Drug); ABT-267 (Drug); Ribavirin (Drug); Ritonavir (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: AbbVie (prior sponsor, Abbott)

Official(s) and/or principal investigator(s):
Daniel Cohen, MD, Study Director, Affiliation: AbbVie

Summary

This is a study of combination direct-acting antiviral agents (DAA) with or without ribavirin (RBV) in patients with chronic Hepatitis C Virus (HCV).

Clinical Details

Official title: A Randomized, Open-Label, Multicenter Study to Evaluate the Antiviral Activity, Safety, and Pharmacokinetics, of ABT-450 With Ritonavir (ABT-450/r) in Combination With ABT-267 and/or ABT-333 With and Without Ribavirin (RBV) for 8, 12 or 24 Weeks in Treatment-Naïve and Null Responder Subjects With Genotype 1 Chronic Hepatitis C Virus Infection

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Number of Participants With Adverse Events (AEs)

Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose for 8 Weeks Versus 12 Weeks of Treatment With 3 DAAs and Ribavirin

Secondary outcome:

Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose Following Treatment of Different Durations With 3 Direct-acting Antiviral Agents (DAAs) and Ribavirin

Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose Following Treatment for 12 Weeks With 2 DAAs and Ribavirin Versus 3 DAAs and Ribavirin

Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose Following Treatment for 12 Weeks With 3 DAAs With Versus Without Ribavirin

Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose in Treatment-naïve Versus Null-responders

Detailed description: A study to evaluate the safety and effectiveness of experimental drugs ABT-450, ABT-267 (also known as ombitasvir), ABT-333 (also known as dasabuvir), ritonavir, and ribavirin in participants with HCV. The study will test the safety and effects of combinations of these drugs in treatments up to 24 weeks.

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Males and females 18-70 years old, inclusive

- Females must be post-menopausal for more than 2 years or surgically sterile or

practicing specific forms of birth control

- Chronic hepatitis C virus (HCV), genotype 1 infection

- Treatment-naive OR null-responders to previous treatment with pegylated interferon

(pegIFN) and ribavirin (at least 12 weeks of treatment and failure to achieve a 2 log10 HCV RNA decrease at Week 12)

- No evidence of liver cirrhosis

Exclusion Criteria:

- Significant liver disease with any cause other than HCV as the primary cause

- Positive hepatitis B surface antigen and anti-human immunodeficiency virus antibody

- Positive screen for drugs and alcohol

- Significant sensitivity to any drug

- Use of contraindicated or prohibited medications within 1 month of dosing

- Abnormal laboratory tests

Locations and Contacts

Site Reference ID/Investigator# 44850, Adelaide 5000, Australia

Site Reference ID/Investigator# 44849, Herston QLD 4029, Australia

Site Reference ID/Investigator# 44852, Kogarah 2217, Australia

Site Reference ID/Investigator# 44084, Calgary T2N 4Z6, Canada

Site Reference ID/Investigator# 43905, Vancouver V5Z 1H2, Canada

Site Reference ID/Investigator# 44755, Clichy 92110, France

Site Reference ID/Investigator# 44758, Creteil 94010, France

Site Reference ID/Investigator# 58884, Lyon 69004, France

Site Reference ID/Investigator# 58887, Marseilles 13285, France

Site Reference ID/Investigator# 58886, Montpellier - Cedex 5 34295, France

Site Reference ID/Investigator# 44754, Paris 75679, France

Site Reference ID/Investigator# 58889, Pessac 33600, France

Site Reference ID/Investigator# 44760, Vandoeuvre Les Nancy 54511, France

Site Reference ID/Investigator# 59303, Berlin 13353, Germany

Site Reference ID/Investigator# 59304, Berlin 10969, Germany

Site Reference ID/Investigator# 46103, Frankfurt 60590, Germany

Site Reference ID/Investigator# 46106, Hamburg 20099, Germany

Site Reference ID/Investigator# 46102, Hannover 30625, Germany

Site Reference ID/Investigator# 58922, Kiel 24146, Germany

Site Reference ID/Investigator# 46105, Wuerzburg 97080, Germany

Site Reference ID/Investigator# 44847, Auckland 1142, New Zealand

Site Reference ID/Investigator# 43672, San Juan 00927, Puerto Rico

Site Reference ID/Investigator# 43675, San Juan 00936-5067, Puerto Rico

Site Reference ID/Investigator# 45363, Barcelona 08028, Spain

Site Reference ID/Investigator# 45668, Barcelona 08035, Spain

Site Reference ID/Investigator# 46485, Barcelona 08003, Spain

Site Reference ID/Investigator# 45667, Madrid 28046, Spain

Site Reference ID/Investigator# 46484, Madrid 28034, Spain

Site Reference ID/Investigator# 45671, Majadahonda (Madrid) 28220, Spain

Site Reference ID/Investigator# 46583, Seville 41014, Spain

Site Reference ID/Investigator# 45405, Valencia 46014, Spain

Site Reference ID/Investigator# 57545, Dundee DD1 9SY, United Kingdom

Site Reference ID/Investigator# 57547, London NW3 2QG, United Kingdom

Site Reference ID/Investigator# 58811, London SE5 9RS, United Kingdom

Site Reference ID/Investigator# 59262, London E1 1BB, United Kingdom

Site Reference ID/Investigator# 57882, Nottingham NG7 2UH, United Kingdom

Site Reference ID/Investigator# 57543, Southampton SO16 6YD, United Kingdom

Site Reference ID/Investigator# 55530, Birmingham, Alabama 35215, United States

Site Reference ID/Investigator# 57583, Birmingham, Alabama 35209, United States

Site Reference ID/Investigator# 55385, Dothan, Alabama 36305, United States

Site Reference ID/Investigator# 55500, Phoenix, Arizona 85054, United States

Site Reference ID/Investigator# 55382, Tucson, Arizona 85724, United States

Site Reference ID/Investigator# 61042, Bakersfield, California 93301, United States

Site Reference ID/Investigator# 43651, Coronado, California 92118, United States

Site Reference ID/Investigator# 43652, Costa Mesa, California 92626, United States

Site Reference ID/Investigator# 59130, Los Angeles, California 90048, United States

Site Reference ID/Investigator# 43565, San Diego, California 92123, United States

Site Reference ID/Investigator# 43910, Aurora, Colorado 80045, United States

Site Reference ID/Investigator# 43572, Bradenton, Florida 34209, United States

Site Reference ID/Investigator# 43584, Fort Pierce, Florida 34982, United States

Site Reference ID/Investigator# 43917, Gainesville, Florida 32610, United States

Site Reference ID/Investigator# 55384, Jacksonville, Florida 32256, United States

Site Reference ID/Investigator# 44610, Wellington, Florida 33414, United States

Site Reference ID/Investigator# 55531, Wellington, Florida 33414, United States

Site Reference ID/Investigator# 55536, Zephyrhills, Florida 33542, United States

Site Reference ID/Investigator# 55540, Macon, Georgia 31201, United States

Site Reference ID/Investigator# 55527, Marietta, Georgia 30060, United States

Site Reference ID/Investigator# 44621, Chicago, Illinois 60637, United States

Site Reference ID/Investigator# 43576, Indianapolis, Indiana 46202-5121, United States

Site Reference ID/Investigator# 55383, Bowling Green, Kentucky 42101, United States

Site Reference ID/Investigator# 59124, Shreveport, Louisiana 71105, United States

Site Reference ID/Investigator# 43568, Annapolis, Maryland 21401, United States

Site Reference ID/Investigator# 55901, Baltimore, Maryland 21201, United States

Site Reference ID/Investigator# 43588, Lutherville, Maryland 21093, United States

Site Reference ID/Investigator# 55534, Boston, Massachusetts 02215, United States

Site Reference ID/Investigator# 43656, Springfield, Massachusetts 01105, United States

Site Reference ID/Investigator# 43655, Ann Arbor, Michigan 48109-0848, United States

Site Reference ID/Investigator# 43913, Detroit, Michigan 48202, United States

Site Reference ID/Investigator# 43587, St. Paul, Minnesota 55114, United States

Site Reference ID/Investigator# 43661, Jackson, Mississippi 39202, United States

Site Reference ID/Investigator# 43569, Kansas City, Missouri 64131, United States

Site Reference ID/Investigator# 44608, St. Louis, Missouri 63104, United States

Site Reference ID/Investigator# 55526, Egg Harbor Township, New Jersey 08234, United States

Site Reference ID/Investigator# 43566, Manhasset, New York 11030, United States

Site Reference ID/Investigator# 59133, Monticello, New York 12701, United States

Site Reference ID/Investigator# 43573, New York, New York 10021, United States

Site Reference ID/Investigator# 43586, New York, New York 10016, United States

Site Reference ID/Investigator# 55532, Poughkeepsie, New York 12601, United States

Site Reference ID/Investigator# 55386, Rochester, New York 14625, United States

Site Reference ID/Investigator# 55538, Charlotte, North Carolina 28207, United States

Site Reference ID/Investigator# 55522, Fayetteville, North Carolina 28304, United States

Site Reference ID/Investigator# 55542, Statesville, North Carolina 28677, United States

Site Reference ID/Investigator# 43665, Cincinnati, Ohio 45267-0595, United States

Site Reference ID/Investigator# 55533, Cincinnati, Ohio 45242, United States

Site Reference ID/Investigator# 43585, Medford, Oregon 97504, United States

Site Reference ID/Investigator# 55539, Portland, Oregon 97225, United States

Site Reference ID/Investigator# 56622, Philadelphia, Pennsylvania 19106, United States

Site Reference ID/Investigator# 43592, Germantown, Tennessee 38138, United States

Site Reference ID/Investigator# 55723, Germantown, Tennessee 38138, United States

Site Reference ID/Investigator# 43659, Nashville, Tennessee 37203, United States

Site Reference ID/Investigator# 59132, Houston, Texas 77005, United States

Site Reference ID/Investigator# 43577, San Antonio, Texas 78215, United States

Site Reference ID/Investigator# 43662, Annandale, Virginia 22003, United States

Site Reference ID/Investigator# 43666, Newport News, Virginia 23602, United States

Site Reference ID/Investigator# 43574, Seattle, Washington 98101, United States

Site Reference ID/Investigator# 43578, Madison, Wisconsin 53792-5124, United States

Site Reference ID/Investigator# 55387, Milwaukee, Wisconsin 53215, United States

Additional Information

Starting date: October 2011
Last updated: April 2, 2015

Page last updated: August 23, 2015

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