A Triple Combination Therapy Study of Boceprevir, Pegasys and Copegus in Previously Untreated Patients With Genotype 1 Chronic Hepatitis C
This study is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01591460
First received: May 2, 2012
Last updated: May 7, 2013
Last verified: May 2013
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Purpose
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.
| 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 ]
| Estimated Enrollment: | 150 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | November 2014 |
| Estimated Primary Completion Date: | November 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01591460
Contacts
| Contact: Please reference Study ID Number: MV28073 www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. Only) | genentechclinicaltrials@druginfo.com |
Locations
| Austria | |
| Active, not recruiting | |
| Graz, Austria, 8036 | |
| Active, not recruiting | |
| Innsbruck, Austria, 6020 | |
| Active, not recruiting | |
| Linz, Austria, 4010 | |
| Active, not recruiting | |
| Wien, Austria, 1090 | |
| Recruiting | |
| Wien, Austria, 1160 | |
| Active, not recruiting | |
| Wien, Austria, 1100 | |
| Germany | |
| Active, not recruiting | |
| Dortmund, Germany, 44263 | |
| Active, not recruiting | |
| Frankfurt Am Main, Germany, 60596 | |
| Active, not recruiting | |
| Hamburg, Germany, 20099 | |
| Recruiting | |
| Hannover, Germany, 30625 | |
| Completed | |
| Oberhausen, Germany, 46145 | |
| Hungary | |
| Active, not recruiting | |
| Budapest, Hungary, 1126 | |
| Active, not recruiting | |
| Budapest, Hungary, 1088 | |
| Active, not recruiting | |
| Budapest, Hungary, 1097 | |
| Active, not recruiting | |
| Debrecen, Hungary, 4032 | |
| Active, not recruiting | |
| Kaposvar, Hungary, 7400 | |
| Active, not recruiting | |
| Pecs, Hungary, 7624 | |
| Poland | |
| Active, not recruiting | |
| Bialystok, Poland, 15-540 | |
| Active, not recruiting | |
| Bydgoszcz, Poland, 85-030 | |
| Active, not recruiting | |
| Chorzow, Poland, 41-500 | |
| Active, not recruiting | |
| Lublin, Poland, 20-081 | |
| Active, not recruiting | |
| ODZ, Poland, 91-347 | |
| Active, not recruiting | |
| Wroclaw, Poland, 51-149 | |
| Romania | |
| Active, not recruiting | |
| Bucharest, Romania, 022328 | |
| Active, not recruiting | |
| Bucharest, Romania, 021105 | |
| Active, not recruiting | |
| Bucharest, Romania, 030303 | |
| Active, not recruiting | |
| Constanta, Romania, 900635 | |
| Active, not recruiting | |
| Timisoara, Romania, 300167 | |
| Spain | |
| Active, not recruiting | |
| Baracaldo, Spain, 48903 | |
| Active, not recruiting | |
| Granada, Spain, 18012 | |
| Active, not recruiting | |
| Vigo, Spain, 36200 | |
| Active, not recruiting | |
| 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: | May 7, 2013 |
| 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 May 19, 2013