Clinical trial NCT01591460: A Triple Combination Therapy Study of Boceprevir, Pegasys and Copegus in Previously Untreated Patients With Genotype 1 Chronic Hepatitis C
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis C, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-05-04
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Percentage of Participants With Sustained Virological Response (SVR) at 12 Weeks After End of Treatment (EOT)
timeFrame: At 12 weeks after EOT (up to 60 weeks)
Secondary outcomes:
measure: Percentage of Participants With SVR at 24 Weeks After EOT
timeFrame: At 24 weeks after EOT (up to 72 weeks)
measure: HCV RNA Levels
timeFrame: 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)
measure: Percentage of Participants With Virological Response
timeFrame: At Weeks 2, 4, 6, 8, 12, 16, 24, 28, and 36; and EOT (up to 48 weeks)
measure: Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA
timeFrame: At Weeks 2, 4, 6, 8, 12, 16, 24, and 28
measure: Percentage of Participants With Virological Relapse Following EOT Response
timeFrame: Up to 72 weeks (at 12 and 24 weeks after EOT)
measure: Percentage of Participants With Virological Breakthrough Following On-Treatment Response
timeFrame: Up to 48 weeks (at Baseline; Weeks 2, 4, 6, 8, 12, 16, 24, 28, and 36; and EOT)
measure: Percentage of Participants With Virological Rebound Following On-Treatment Decline in HCV RNA
timeFrame: Up to 48 weeks (at Baseline; Weeks 2, 4, 6, 8, 12, 16, 24, 28, and 36; and EOT)
measure: Percentage of Participants With Treatment Discontinued Based Upon Elevated (Week 12) or Detectable (Week 24) HCV RNA
timeFrame: At 12 and 24 weeks
measure: Duration of Treatment With PEG-IFN, RBV, and Boceprevir
timeFrame: Up to 48 weeks (from Baseline until EOT)
measure: Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason
timeFrame: Up to 48 weeks (from Baseline until EOT)
measure: Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir
timeFrame: Up to 48 weeks (from Baseline until EOT)
measure: Number of Participants With a Safety-Related Dose Modification
timeFrame: Up to 48 weeks (from Baseline until EOT)
measure: Time to Safety-Related Dose Modification
timeFrame: Up to 48 weeks (from Baseline until EOT)
measure: Percentage of Participants Using Concomitant Hematopoietic Stimulants During Treatment and Follow-Up
timeFrame: Up to 72 weeks (from Baseline until 24 weeks after EOT)
measure: Percentage of Participants With a Concomitant Disease Prior to or During the Study
timeFrame: Up to 76 weeks (from Screening until 24 weeks after EOT)
measure: Percentage of Participants Using Concomitant Medications During Treatment and Follow-Up
timeFrame: Up to 72 weeks (from Baseline until 24 weeks after EOT)
Other outcomes:
Locations:
city: Graz
country: Austria
city: Innsbruck
country: Austria
city: Linz
country: Austria
city: Wien
country: Austria
city: Wien
country: Austria
city: Wien
country: Austria
city: Dortmund
country: Germany
city: Frankfurt am Main
country: Germany
city: Hamburg
country: Germany
city: Hannover
country: Germany
city: Oberhausen
country: Germany
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Kaposvar
country: Hungary
city: Pecs
country: Hungary
city: Bialystok
country: Poland
city: Bydgoszcz
country: Poland
city: Chorzow
country: Poland
city: Lublin
country: Poland
city: Wrocław
country: Poland
city: Łodz
country: Poland
city: Bucharest
country: Romania
city: Bucharest
country: Romania
city: Bucharest
country: Romania
city: Constanta
country: Romania
city: Timisoara
country: Romania
city: Vigo
country: Spain
state: Pontevedra
city: Baracaldo
country: Spain
state: Vizcaya
city: Granada
country: Spain
city: Zaragoza
country: Spain
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.