Peak Study - A Study of Pegasys (Peginterferon Alfa-2a (40KD)) in Combination With Copegus (Ribavirin) in Interferon-Naive Patients With Chronic Hepatitis C (CHC).
NCT ID: NCT00087607
Last Updated: 2016-07-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
385 participants
INTERVENTIONAL
2004-01-31
2006-04-30
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
NONE
Study Groups
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Peginterferon Alfa-2a + Ribavirin
Participants received Peginterferon alfa-2a (40 kD) \[Pegasys\] at a dosage of 180 microgram (μg), subcutaneously (SC), once a week plus Ribavirin \[Copegus\] 1000 or 1200 milligram (mg)/day), orally, \[according to body weight, lesser than or greater than/equal to (\< or \>/=) 75 kilogram (kg), respectively\] twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (\< or \>/=75 kg body weight, respectively twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
Ribavirin
1000/1200mg/day po
Peginterferon alfa-2a [Pegasys]
180 micrograms sc weekly
Peginterferon Alfa-2b + Ribavirin
Participants received Peginterferon alfa-2b (12 kD) \[PEG-Intron\] at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin \[Rebetol\] 1000 or 1200 mg/day orally (\< or \>/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (\< or \>/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
Peginterferon alfa-2b (PEG-Intron)
1.5 micrograms/kg sc weekly
Ribavirin
1000/1200mg/day po
Interventions
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Ribavirin
1000/1200mg/day po
Peginterferon alfa-2b (PEG-Intron)
1.5 micrograms/kg sc weekly
Ribavirin
1000/1200mg/day po
Peginterferon alfa-2a [Pegasys]
180 micrograms sc weekly
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* CHC infection, genotype 1
* use of 2 forms of contraception during study in both men and women
Exclusion Criteria
* medical condition associated with chronic liver disease (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposure)
* decompensated liver disease
* women who are pregnant or breastfeeding
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Birmingham, Alabama, United States
Little Rock, Arkansas, United States
Sacramento, California, United States
San Diego, California, United States
San Diego, California, United States
San Francisco, California, United States
San Mateo, California, United States
San Rafael, California, United States
Farmington, Connecticut, United States
Hartford, Connecticut, United States
Bradenton, Florida, United States
Miami, Florida, United States
Wellington, Florida, United States
Kansas City, Kansas, United States
New Orleans, Louisiana, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Burlington, Massachusetts, United States
Detroit, Michigan, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
East Orange, New Jersey, United States
Egg Harbour Township, New Jersey, United States
Vineland, New Jersey, United States
New York, New York, United States
New York, New York, United States
Poughkeepsie, New York, United States
The Bronx, New York, United States
Fayetteville, North Carolina, United States
Statesville, North Carolina, United States
Portland, Oregon, United States
Columbia, South Carolina, United States
Austin, Texas, United States
Dallas, Texas, United States
Fairfax, Virginia, United States
Norfolk, Virginia, United States
Roanoke, Virginia, United States
Tacoma, Washington, United States
Racine, Wisconsin, United States
Countries
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References
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Chung RT, Poordad FF, Hassanein T, Zhou X, Lentz E, Prabhakar A, Di Bisceglie AM. Association of host pharmacodynamic effects with virologic response to pegylated interferon alfa-2a/ribavirin in chronic hepatitis C. Hepatology. 2010 Dec;52(6):1906-14. doi: 10.1002/hep.23947. Epub 2010 Nov 9.
Di Bisceglie AM, Ghalib RH, Hamzeh FM, Rustgi VK. Early virologic response after peginterferon alpha-2a plus ribavirin or peginterferon alpha-2b plus ribavirin treatment in patients with chronic hepatitis C. J Viral Hepat. 2007 Oct;14(10):721-9. doi: 10.1111/j.1365-2893.2007.00862.x.
Other Identifiers
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ML17756
Identifier Type: -
Identifier Source: org_study_id
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