A Triple Combination Therapy Study of Boceprevir, Pegasys and Copegus in Previously Untreated Patients With Genotype 1 Chronic Hepatitis C
NCT ID: NCT01591460
Last Updated: 2016-11-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
165 participants
INTERVENTIONAL
2012-08-31
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Dual Combination Therapy
peginterferon alfa-2a [Pegasys]
180 mcg subcutaneously once a week for 4 weeks
ribavirin (Copegus]
1000 mg or 1200 mg orally once a day for 4 weeks
Triple Combination Therapy
boceprevir
800 mg three times daily for 24, 32 or 44 weeks
peginterferon alfa-2a [Pegasys]
180 mcg subcutaneously once a week for 24, 32 or 44 weeks
ribavirin (Copegus]
1000 mg or 1200 mg orally once a day for 24, 32 or 44 weeks
Interventions
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boceprevir
800 mg three times daily for 24, 32 or 44 weeks
peginterferon alfa-2a [Pegasys]
180 mcg subcutaneously once a week for 24, 32 or 44 weeks
peginterferon alfa-2a [Pegasys]
180 mcg subcutaneously once a week for 4 weeks
ribavirin (Copegus]
1000 mg or 1200 mg orally once a day for 24, 32 or 44 weeks
ribavirin (Copegus]
1000 mg or 1200 mg orally once a day for 4 weeks
Eligibility Criteria
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Inclusion Criteria
* Chronic liver disease consistent with chronic hepatitis C, genotype 1 infection
* Serum HCV RNA quantifiable at screening
* Patients who have not been previously treated with pegylated interferon (IFN), standard IFN, RBV or any direct acting anti-viral agent
* Compensated liver disease (Child-Pugh Grade A clinical classification for patients with cirrhosis: total score \</=6)
* Negative urine or blood pregnancy test (for women of childbearing potential)
Exclusion Criteria
* Male partners of women who are pregnant
* Therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment \</=6 months prior to the first dose of study drug
* Any investigational drug \</=6 weeks prior to the first dose of study drug
* History or other evidence of decompensated liver disease
* History or other evidence of a medical condition associated with chronic liver disease other than chronic hepatitis C
* Signs or symptoms of hepatocellular carcinoma
* Co-infection with HCV genotypes other than genotype 1
* Co-infection with hepatitis A, hepatitis B, and/or human immunodeficiency virus (HIV)
* Any patient with an increased risk for anemia
* History of severe psychiatric disease
* History of immunologically mediated, chronic pulmonary, or severe cardiac disease
* Current diseases that are not adequately controlled
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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Graz, , Austria
Innsbruck, , Austria
Linz, , Austria
Vienna, , Austria
Vienna, , Austria
Vienna, , Austria
Dortmund, , Germany
Frankfurt am Main, , Germany
Hamburg, , Germany
Hanover, , Germany
Oberhausen, , Germany
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Debrecen, , Hungary
Kaposvár, , Hungary
Pécs, , Hungary
Bialystok, , Poland
Bydgoszcz, , Poland
Chorzów, , Poland
Lodz, , Poland
Lublin, , Poland
Wroclaw, , Poland
Bucharest, , Romania
Bucharest, , Romania
Bucharest, , Romania
Constanța, , Romania
Timișoara, , Romania
Granada, Granada, Spain
Vigo, Pontevedra, Spain
Barakaldo, Vizcaya, Spain
Zaragoza, Zaragoza, Spain
Countries
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References
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Ferenci P, Caruntu FA, Lengyel G, Messinger D, Bakalos G, Flisiak R. Boceprevir Plus Peginterferon Alfa-2a/Ribavirin in Treatment-Naive Hepatitis C Virus Genotype 1 Patients: International Phase IIIb/IV TriCo Trial. Infect Dis Ther. 2016 Jun;5(2):113-24. doi: 10.1007/s40121-016-0110-5. Epub 2016 May 26.
Other Identifiers
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2011-004810-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MV28073
Identifier Type: -
Identifier Source: org_study_id