A Triple Combination Therapy Study of Boceprevir, Pegasys and Copegus in Previously Untreated Patients With Genotype 1 Chronic Hepatitis C
An International, Multicenter, Open-Label Study Evaluating Sustained Virological Response and Safety With Boceprevir in Triple Combination Therapy With Peginterferon Alfa-2a (40KD) and Ribavirin in Treatment-Naïve Patients With Genotype 1 Chronic Hepatitis C
2 other identifiers
interventional
165
6 countries
32
Brief Summary
This open-label, multicenter, treatment response guided study will evaluate the sustained virological response and safety of the triple combination therapy boceprevir, Pegasys (peginterferon alfa-2a) and Copegus (Ribavirin) in previously untreated patients with genotype 1 chronic hepatitis C. In the lead-in phase, patients will receive a dual combination therapy of Pegasys and Copegus for 4 weeks. In the following triple combination therapy phase, 800 mg boceprevir, 180 mcg Pegasys and 1000-1200 mg Copegus will be administered for 24, 32 or 44 weeks; the duration depending on the patient's treatment response. The anticipated time on study treatment is up to 48 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Aug 2012
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 2, 2012
CompletedFirst Posted
Study publicly available on registry
May 4, 2012
CompletedStudy Start
First participant enrolled
August 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedResults Posted
Study results publicly available
August 7, 2015
CompletedNovember 2, 2016
November 1, 2016
1.8 years
May 2, 2012
July 10, 2015
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Sustained Virological Response (SVR) at 12 Weeks After End of Treatment (EOT)
SVR at 12 weeks after EOT was defined as an undetectable HCV RNA viral load obtained 12 weeks following completion of treatment. HCV RNA viral load was measured using the Roche COBAS TaqMan 2.0 HCV Test, with a lower limit of detection (LOD) of 10 to 15 international units per milliliter (IU/mL). The percentage of participants with SVR was calculated as \[number of participants with undetectable HCV RNA at 12 weeks after EOT divided by the number of participants analyzed\] multiplied by 100.
At 12 weeks after EOT (up to 60 weeks)
Secondary Outcomes (16)
Percentage of Participants With SVR at 24 Weeks After EOT
At 24 weeks after EOT (up to 72 weeks)
HCV RNA Levels
At Baseline; Weeks 2, 4, 6, 8, 12, 16, 24, 28, and 36; EOT; and 12 and 24 weeks after EOT (up to 72 weeks)
Percentage of Participants With Virological Response
At Weeks 2, 4, 6, 8, 12, 16, 24, 28, and 36; and EOT (up to 48 weeks)
Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA
At Weeks 2, 4, 6, 8, 12, 16, 24, and 28
Percentage of Participants With Virological Relapse Following EOT Response
Up to 72 weeks (at 12 and 24 weeks after EOT)
- +11 more secondary outcomes
Study Arms (2)
Dual Combination Therapy
EXPERIMENTALTriple Combination Therapy
EXPERIMENTALInterventions
180 mcg subcutaneously once a week for 24, 32 or 44 weeks
1000 mg or 1200 mg orally once a day for 24, 32 or 44 weeks
Eligibility Criteria
You may qualify if:
- Adult patients \>/=18 years of age
- 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)
You may not qualify if:
- Women with ongoing pregnancy or breast feeding
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
Unknown Facility
Graz, 8036, Austria
Unknown Facility
Innsbruck, 6020, Austria
Unknown Facility
Linz, 4010, Austria
Unknown Facility
Vienna, 1090, Austria
Unknown Facility
Vienna, 1100, Austria
Unknown Facility
Vienna, 1160, Austria
Unknown Facility
Dortmund, 44263, Germany
Unknown Facility
Frankfurt am Main, 60594, Germany
Unknown Facility
Hamburg, 20099, Germany
Unknown Facility
Hanover, 30625, Germany
Unknown Facility
Oberhausen, 46145, Germany
Unknown Facility
Budapest, 1088, Hungary
Unknown Facility
Budapest, 1097, Hungary
Unknown Facility
Budapest, 1126, Hungary
Unknown Facility
Debrecen, 4032, Hungary
Unknown Facility
Kaposvár, 7400, Hungary
Unknown Facility
Pécs, 7624, Hungary
Unknown Facility
Bialystok, 15-540, Poland
Unknown Facility
Bydgoszcz, 85-030, Poland
Unknown Facility
Chorzów, 41-500, Poland
Unknown Facility
Lodz, 91-347, Poland
Unknown Facility
Lublin, 20-081, Poland
Unknown Facility
Wroclaw, 50-349, Poland
Unknown Facility
Bucharest, 021105, Romania
Unknown Facility
Bucharest, 022328, Romania
Unknown Facility
Bucharest, 030303, Romania
Unknown Facility
Constanța, 900635, Romania
Unknown Facility
Timișoara, 300167, Romania
Unknown Facility
Granada, Granada, 18012, Spain
Unknown Facility
Vigo, Pontevedra, 36200, Spain
Unknown Facility
Barakaldo, Vizcaya, 48903, Spain
Unknown Facility
Zaragoza, Zaragoza, 50009, Spain
Related Publications (1)
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.
PMID: 27228998DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-LaRoche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 2, 2012
First Posted
May 4, 2012
Study Start
August 1, 2012
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
November 2, 2016
Results First Posted
August 7, 2015
Record last verified: 2016-11