A Triple Combination Therapy Study of Boceprevir, Pegasys and Copegus in Previously Untreated Patients With Genotype 1 Chronic Hepatitis C

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01591460
First received: May 2, 2012
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

This open-label, multicenter, treatment response guided study will evaluate the sustained virological response and safety of the triple combination therapy boce previr, Pegasys (peginterferon alfa-2a) and Copegus (Ribavirin) in previously un treated patients with genotype 1 chronic hepatitis C. In the lead-in phase, pati ents 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 P egasys 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.


Condition Intervention Phase
Hepatitis C, Chronic
Drug: boceprevir
Drug: peginterferon alfa-2a [Pegasys]
Drug: ribavirin (Copegus]
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Sustained virological response 12 weeks after treatment end (SVR12) [ Time Frame: Up to 60 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sustained virological response 24 weeks after treatment end [ Time Frame: Up to 72 weeks ] [ Designated as safety issue: No ]
  • Level of hepatitis C virus RNA [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
  • End of treatment response [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Virological Relapse rate [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Safety: incidence of adverse events [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]

Enrollment: 165
Study Start Date: August 2012
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dual Combination Therapy Drug: peginterferon alfa-2a [Pegasys]
180 mcg subcutaneously once a week for 4 weeks
Drug: ribavirin (Copegus]
1000 mg or 1200 mg orally once a day for 4 weeks
Experimental: Triple Combination Therapy Drug: boceprevir
800 mg three times daily for 24, 32 or 44 weeks
Drug: peginterferon alfa-2a [Pegasys]
180 mcg subcutaneously once a week for 24, 32 or 44 weeks
Drug: ribavirin (Copegus]
1000 mg or 1200 mg orally once a day for 24, 32 or 44 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01591460

Locations
Austria
Graz, Austria, 8036
Innsbruck, Austria, 6020
Linz, Austria, 4010
Wien, Austria, 1090
Wien, Austria, 1160
Wien, Austria, 1100
Germany
Dortmund, Germany, 44263
Frankfurt am Main, Germany, 60594
Hamburg, Germany, 20099
Hannover, Germany, 30625
Oberhausen, Germany, 46145
Hungary
Budapest, Hungary, 1126
Budapest, Hungary, 1088
Budapest, Hungary, 1097
Debrecen, Hungary, 4032
Kaposvar, Hungary, 7400
Pecs, Hungary, 7624
Poland
Bialystok, Poland, 15-540
Bydgoszcz, Poland, 85-030
Chorzow, Poland, 41-500
Lodz, Poland, 91-347
Lublin, Poland, 20-081
Wroclaw, Poland, 50-349
Romania
Bucharest, Romania, 022328
Bucharest, Romania, 021105
Bucharest, Romania, 030303
Constanta, Romania, 900635
Timisoara, Romania, 300167
Spain
Vigo, Pontevedra, Spain, 36200
Baracaldo, Vizcaya, Spain, 48903
Granada, Spain, 18012
Zaragoza, Spain, 50009
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01591460     History of Changes
Other Study ID Numbers: MV28073, 2011-004810-41
Study First Received: May 2, 2012
Last Updated: July 7, 2014
Health Authority: Austria: Bundesamt für Sicherheit im Gesundheitswesen AGES Pharm Med

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Peginterferon alfa-2a
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 20, 2014