A Randomized Study to Evaluate the Safety, Tolerability and Antiviral Activity of ABT-450, ABT-333 and ABT-072
NCT ID: NCT01074008
Last Updated: 2015-01-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
74 participants
INTERVENTIONAL
2010-03-31
2012-01-31
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-450/r (50/100 mg) once daily (QD) + pegIFN/RBV
Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-450
50 mg capsules co-administered with ritonavir
Ritonavir
100 mg capsules co-administered with ABT-450
Peginterferon alpha-2a
Syringe, 180 µg/0.5 mL for subcutaneous injections
Ribavirin
200 mg tablet dosed at 1000 or 1200 mg daily divided twice a day
ABT-450/r (100/100 mg) once daily (QD) + pegIFN/RBV
Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-450
50 mg capsules co-administered with ritonavir
Ritonavir
100 mg capsules co-administered with ABT-450
Peginterferon alpha-2a
Syringe, 180 µg/0.5 mL for subcutaneous injections
Ribavirin
200 mg tablet dosed at 1000 or 1200 mg daily divided twice a day
ABT-450/r (200/100 mg) once daily (QD) + pegIFN/RBV
Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-450
50 mg capsules co-administered with ritonavir
Ritonavir
100 mg capsules co-administered with ABT-450
Peginterferon alpha-2a
Syringe, 180 µg/0.5 mL for subcutaneous injections
Ribavirin
200 mg tablet dosed at 1000 or 1200 mg daily divided twice a day
ABT-072 (100 mg) once daily (QD) + pegIFN/RBV
Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072
50 mg tablet
Peginterferon alpha-2a
Syringe, 180 µg/0.5 mL for subcutaneous injections
Ribavirin
200 mg tablet dosed at 1000 or 1200 mg daily divided twice a day
ABT-072 (300 mg) once daily (QD) + pegIFN/RBV
Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072
50 mg tablet
Peginterferon alpha-2a
Syringe, 180 µg/0.5 mL for subcutaneous injections
Ribavirin
200 mg tablet dosed at 1000 or 1200 mg daily divided twice a day
ABT-072 (600 mg) once daily (QD) + pegIFN/RBV
Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072
50 mg tablet
Peginterferon alpha-2a
Syringe, 180 µg/0.5 mL for subcutaneous injections
Ribavirin
200 mg tablet dosed at 1000 or 1200 mg daily divided twice a day
ABT-333 (400 mg) twice a day (BID) + pegIFN/RBV
Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-333
400 mg tablet
Peginterferon alpha-2a
Syringe, 180 µg/0.5 mL for subcutaneous injections
Ribavirin
200 mg tablet dosed at 1000 or 1200 mg daily divided twice a day
ABT-333 (800 mg) twice daily (BID) + pegIFN/RBV
Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-333
400 mg tablet
Peginterferon alpha-2a
Syringe, 180 µg/0.5 mL for subcutaneous injections
Ribavirin
200 mg tablet dosed at 1000 or 1200 mg daily divided twice a day
Placebo + pegIFN/RBV
Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Peginterferon alpha-2a
Syringe, 180 µg/0.5 mL for subcutaneous injections
Ribavirin
200 mg tablet dosed at 1000 or 1200 mg daily divided twice a day
Placebo
Matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level
Interventions
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ABT-450
50 mg capsules co-administered with ritonavir
ABT-072
50 mg tablet
ABT-333
400 mg tablet
Ritonavir
100 mg capsules co-administered with ABT-450
Peginterferon alpha-2a
Syringe, 180 µg/0.5 mL for subcutaneous injections
Ribavirin
200 mg tablet dosed at 1000 or 1200 mg daily divided twice a day
Placebo
Matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Liver biopsy within 3 years with histology consistent with HCV-induced liver damage, with no evidence of cirrhosis or liver pathology due to any cause other than chronic HCV
* Treatment naïve male or female between the ages of 18 and 65
* Females must be post-menopausal for more than 2 years or surgically sterile
* Negative screen for drugs and alcohol
* Negative hepatitis B surface antigen (HBsAg) and anti-human immunodeficiency virus antibodies (anti-HIV Ab)
* No use of cytochrome P450 3A (CYP3A) and cytochrome P450 2C8 (CYP2C8) enzyme inducers or inhibitors within 1 month of dosing
* Be in a condition of general good health, as perceived by the investigator, other than HCV infection
Exclusion Criteria
* Use of herbal supplements within 2 weeks prior to study drug dosing
* History of major depression within 2 years
* Prior treatment with any investigational or commercially available anti-HCV agents
* Abnormal laboratory tests
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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Daniel Cohen
Role: STUDY_DIRECTOR
AbbVie
Locations
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Site Reference ID/Investigator# 23392
Phoenix, Arizona, United States
Site Reference ID/Investigator# 23370
Anaheim, California, United States
Site Reference ID/Investigator# 23387
La Jolla, California, United States
Site Reference ID/Investigator# 23388
Los Angeles, California, United States
Site Reference ID/Investigator# 23371
Aurora, Colorado, United States
Site Reference ID/Investigator# 23369
Orlando, Florida, United States
Site Reference ID/Investigator# 26362
Orlando, Florida, United States
Site Reference ID/Investigator# 23373
Chicago, Illinois, United States
Site Reference ID/Investigator# 24908
Chicago, Illinois, United States
Site Reference ID/Investigator# 23381
Indianapolis, Indiana, United States
Site Reference ID/Investigator# 23372
Baton Rouge, Louisiana, United States
Site Reference ID/Investigator# 24710
New Orleans, Louisiana, United States
Site Reference ID/Investigator# 23391
Baltimore, Maryland, United States
Site Reference ID/Investigator# 23377
Detroit, Michigan, United States
Site Reference ID/Investigator# 24909
Saint Paul, Minnesota, United States
Site Reference ID/Investigator# 35842
New York, New York, United States
Site Reference ID/Investigator# 23379
New York, New York, United States
Site Reference ID/Investigator# 23375
Chapel Hill, North Carolina, United States
Site Reference ID/Investigator# 23385
Durham, North Carolina, United States
Site Reference ID/Investigator# 23376
Dallas, Texas, United States
Site Reference ID/Investigator# 24891
Houston, Texas, United States
Site Reference ID/Investigator# 23382
San Antonio, Texas, United States
Site Reference ID/Investigator# 24715
Salt Lake City, Utah, United States
Site Reference ID/Investigator# 25463
Seattle, Washington, United States
Site Reference ID/Investigator# 23383
Madison, Wisconsin, United States
Site Reference ID/Investigator# 23363
Ponce, , Puerto Rico
Countries
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References
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Pilot-Matias T, Tripathi R, Cohen D, Gaultier I, Dekhtyar T, Lu L, Reisch T, Irvin M, Hopkins T, Pithawalla R, Middleton T, Ng T, McDaniel K, Or YS, Menon R, Kempf D, Molla A, Collins C. In vitro and in vivo antiviral activity and resistance profile of the hepatitis C virus NS3/4A protease inhibitor ABT-450. Antimicrob Agents Chemother. 2015 Feb;59(2):988-97. doi: 10.1128/AAC.04227-14. Epub 2014 Dec 1.
Related Links
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Related Info
Other Identifiers
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M11-602
Identifier Type: -
Identifier Source: org_study_id
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