A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Multiple Doses of ABT-333 Alone and in Combination With Pegylated Interferon (pegIFN) and Ribavirin (RBV) in Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
NCT ID: NCT00851890
Last Updated: 2018-07-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
30 participants
INTERVENTIONAL
2009-03-31
2009-07-31
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
DOUBLE
Study Groups
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ABT-333 (300 mg) twice daily (BID) + pegIFN/RBV
Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-333
50 mg capsules
Pegylated interferon
Syringe, 180 µg/0.5 mL for subcutaneous injections administered weekly
Ribavirin
200 mg tablet dosed at 1000 or 1200 mg daily divided twice a day
ABT-333 (600 mg) twice daily (BID) + pegIFN/RBV
Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-333
50 mg capsules
Pegylated interferon
Syringe, 180 µg/0.5 mL for subcutaneous injections administered weekly
Ribavirin
200 mg tablet dosed at 1000 or 1200 mg daily divided twice a day
ABT-333 (1200 mg) once daily (QD) + pegIFN/RBV
Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-333
50 mg capsules
Pegylated interferon
Syringe, 180 µg/0.5 mL for subcutaneous injections administered weekly
Ribavirin
200 mg tablet dosed at 1000 or 1200 mg daily divided twice a day
Placebo + pegIFN/RBV
Hepatitis C virus (HCV) positive, treatment-naïve participants received matching placebo once daily (QD) or twice daily (BID) for 2 days followed by placebo QD or BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Placebo for ABT-333
Capsule
Pegylated interferon
Syringe, 180 µg/0.5 mL for subcutaneous injections administered weekly
Ribavirin
200 mg tablet dosed at 1000 or 1200 mg daily divided twice a day
Interventions
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ABT-333
50 mg capsules
Placebo for ABT-333
Capsule
Pegylated interferon
Syringe, 180 µg/0.5 mL for subcutaneous injections administered weekly
Ribavirin
200 mg tablet dosed at 1000 or 1200 mg daily divided twice a day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* If female, participant is postmenopausal or surgically sterile.
* If male, must be practicing two effective methods of birth control.
* Participant is hepatitis C virus (HCV) genotype 1 with HCV ribonucleic acid levels \>50,000 IU/mL.
* Participants must demonstrate chronic hepatitis C infection for at least 6 months prior to study enrollment.
* Participants must have a liver biopsy with histology consistent with HCV-induced liver damage, and with no evidence of cirrhosis or liver pathology due to any cause other than chronic HCV.
* Condition of general good health other then HCV infection.
* Participants with a history of thyroid disease must have a thyroid stimulating hormone (TSH) value in the normal range.
Exclusion Criteria
* Positive test result for hepatitis A virus immunoglobulin M (HAV-IgM), hepatitis B surface antigen (HBsAg), or human immunodeficiency virus antibody (HIV Ab).
* Pregnant or breastfeeding females or male partners of women who are pregnant.
* History of seizures or cancer.
* History of major depressive disorder within 2 years.
* Any current or past history of cirrhosis.
* Any cause of liver disease other than chronic HCV infection.
18 Years
70 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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Daniel Cohen, MD
Role: STUDY_DIRECTOR
AbbVie
Locations
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Site Reference ID/Investigator# 16103
Anaheim, California, United States
Site Reference ID/Investigator# 16124
Los Angeles, California, United States
Site Reference ID/Investigator# 16102
Orlando, Florida, United States
Site Reference ID/Investigator# 16105
Baton Rouge, Louisiana, United States
Site Reference ID/Investigator# 16106
Chapel Hill, North Carolina, United States
Site Reference ID/Investigator# 16107
Dallas, Texas, United States
Site Reference ID/Investigator# 16123
San Antonio, Texas, United States
Site Reference ID/Investigator# 16182
Santurce, , 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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M10-380
Identifier Type: -
Identifier Source: org_study_id
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