Study of ABT-267 in Treatment Naive Hepatitis C Virus (HCV) Genotype 1 Infected Subjects
NCT ID: NCT01314261
Last Updated: 2018-07-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
37 participants
INTERVENTIONAL
2011-03-31
2013-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ABT-267 (5 mg) once daily + pegIFN/RBV
Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
ABT-267
5 mg or 25 mg tablets
Pegylated interferon (pegIFN)
Syringe, 180 µg/0.5 mL for subcutaneous injections administered weekly
Ribavirin (RBV)
200 mg tablet dosed at 1000 or 1200 mg daily divided twice a day
ABT-267 (50 mg) once daily + pegIFN/RBV
Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
ABT-267
5 mg or 25 mg tablets
Pegylated interferon (pegIFN)
Syringe, 180 µg/0.5 mL for subcutaneous injections administered weekly
Ribavirin (RBV)
200 mg tablet dosed at 1000 or 1200 mg daily divided twice a day
ABT-267 (200 mg) once daily + pegIFN/RBV
Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
ABT-267
5 mg or 25 mg tablets
Pegylated interferon (pegIFN)
Syringe, 180 µg/0.5 mL for subcutaneous injections administered weekly
Ribavirin (RBV)
200 mg tablet dosed at 1000 or 1200 mg daily divided twice a day
Placebo + pegIFN/RBV
Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
Pegylated interferon (pegIFN)
Syringe, 180 µg/0.5 mL for subcutaneous injections administered weekly
Ribavirin (RBV)
200 mg tablet dosed at 1000 or 1200 mg daily divided twice a day
Placebo for ABT-267
Participants received matching placebo tablet at each dose level for ABT-267.
Interventions
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ABT-267
5 mg or 25 mg tablets
Pegylated interferon (pegIFN)
Syringe, 180 µg/0.5 mL for subcutaneous injections administered weekly
Ribavirin (RBV)
200 mg tablet dosed at 1000 or 1200 mg daily divided twice a day
Placebo for ABT-267
Participants received matching placebo tablet at each dose level for ABT-267.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Females must be either postmenopausal for at least 2 years or surgically sterile
* Males must be surgically sterile or practicing specific forms of birth control
* Chronic hepatitis C virus (HCV), genotype-1 infected participants
* Documented FibroTest score in combination with an Aspartate Aminotransferase to Platelet Ratio Index (APRI), or a liver biopsy within the last 12 months to document absence of cirrhosis
Exclusion Criteria
* Use of any medications contraindicated for use with pegylated interferon(pegIFN) or ribavirin (RBV) 2 weeks prior to study drug administration or 10 half-lives, whichever is longer
* Clinically significant cardiac, respiratory (except mild asthma), renal, gastrointestinal, hematologic, neurologic disease, or any uncontrolled medical illness or psychiatric disease or disorder
* Current or past clinical evidence of cirrhosis or bridging fibrosis
* Abnormal screening laboratory results
18 Years
65 Years
ALL
No
Sponsors
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AbbVie (prior sponsor, Abbott)
INDUSTRY
Responsible Party
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Principal Investigators
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Armen Asatryan, MD
Role: STUDY_DIRECTOR
AbbVie
Locations
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Site Reference ID/Investigator# 56623
Birmingham, Alabama, United States
Site Reference ID/Investigator# 48476
Los Angeles, California, United States
Site Reference ID/Investigator# 51345
Orlando, Florida, United States
Site Reference ID/Investigator# 51498
Honolulu, Hawaii, United States
Site Reference ID/Investigator# 48473
Indianapolis, Indiana, United States
Site Reference ID/Investigator# 52782
Kansas City, Missouri, United States
Site Reference ID/Investigator# 48471
Houston, Texas, United States
Site Reference ID/Investigator# 48474
San Antonio, Texas, United States
Site Reference ID/Investigator# 48477
Fairfax, Virginia, United States
Site Reference ID/Investigator# 48472
Seattle, Washington, United States
Site Reference ID/Investigator# 48483
San Juan, , Puerto Rico
Countries
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References
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Mensing S, Polepally AR, Konig D, Khatri A, Liu W, Podsadecki TJ, Awni WM, Menon RM, Dutta S. Population Pharmacokinetics of Paritaprevir, Ombitasvir, Dasabuvir, Ritonavir, and Ribavirin in Patients with Hepatitis C Virus Genotype 1 Infection: Combined Analysis from 9 Phase 1b/2 Studies. AAPS J. 2016 Jan;18(1):270-80. doi: 10.1208/s12248-015-9846-1. Epub 2015 Nov 23.
Related Links
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Related Info
Other Identifiers
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M12-114
Identifier Type: -
Identifier Source: org_study_id
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