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Trial record 31 of 540 for:    IFNA2 AND RBV AND IFN alfa-2

A Study of Combination Therapy With PEGASYS (Pegylated Interferon Alfa-2a (40KD)) and Copegus (Ribavirin) in Patients With Chronic Hepatitis C Genotype 2 or 3 Who Do Not Achieve a Rapid Viral Response

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ClinicalTrials.gov Identifier: NCT00623428
Recruitment Status : Completed
First Posted : February 26, 2008
Results First Posted : June 24, 2013
Last Update Posted : July 22, 2013
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This study will evaluate the efficacy and safety of peginterferon alfa-2a 40KD + ribavirin combination therapy given for 24 weeks versus 48 weeks in patients with chronic hepatitis C, genotype 2/3.

Condition or disease Intervention/treatment Phase
Hepatitis C, Chronic Drug: peginterferon alfa-2a Drug: Ribavirin Phase 3

Detailed Description:

During a pre-study run-in phase patients with chronic hepatitis C genotype 2/3, who had started therapy with PEG-IFN alfa-2a plus ribavirin according to local standard of care and did not achieve a rapid viral response (RVR) (defined as Hepatitis C virus (HCV) RNA <15 IU/mL at Week 4 of treatment measured with the Roche COBAS AmpliPrep / COBAS TaqMan® HCV Test) were eligible for the study and entered the screening phase between treatment Week 4 and 8 as soon as the result of the Week 4 HCV RNA test was available.

Eligible patients entered the study and continued with the dose regimens of PEG-IFN alfa-2a and ribavirin they were taking prior to enrolment into the trial up to Week 24 of treatment. Patients who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24, were randomized at treatment Week 24 to one of the two study groups. Upon randomization, participants either stopped treatment (equaling 24 weeks of treatment) or continued treatment for another 24 weeks (equaling 48 weeks of treatment). A treatment free follow-up period of 24 weeks (for participants in the 48-week treatment group) or 48 weeks (participants in the 24-week treatment group) completed the study.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 235 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label Study of the Effects of 24 vs 48 Weeks of Combination Therapy With PEGASYS (Peginterferon Alfa-2a 40KD) Plus COPEGUS (Ribavirin) on Sustained Virological Response in Patients With Chronic Hepatitis C, Genotype 2 or 3 Who do Not Achieve a Rapid Viral Response
Study Start Date : June 2008
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PEG-IFN alfa-2a + Ribavirin for 24 weeks
After 24 weeks of treatment with pegylated interferon alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period.
Drug: peginterferon alfa-2a
Other Names:
  • Pegasys®
  • PEG-IFN alfa-2a

Drug: Ribavirin
Other Name: Copegus®

Active Comparator: PEG-IFN alfa-2a + Ribavirin for 48 weeks
After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.
Drug: peginterferon alfa-2a
Other Names:
  • Pegasys®
  • PEG-IFN alfa-2a

Drug: Ribavirin
Other Name: Copegus®




Primary Outcome Measures :
  1. Percentage of Participants With a Sustained Virologic Response 24 Weeks After Scheduled Completion of Treatment [ Time Frame: 24 weeks after scheduled treatment completion (approximately Week 48 for participants in the 24-week treatment group and Week 72 for participants in the 48-week treatment group. ]

    Sustained virological response (SVR) is defined as a single last HCV RNA measurement <15 IU/ml (measured using the Roche COBAS AmpliPrep / COBAS TaqMan HCV Test) 24 weeks after scheduled treatment completion, defined as Week 44 or later for participants randomized to the 24-week treatment period or Week 68 or later for participants randomized to the 48-week treatment period.

    Participants without measurements at the end of the 24-week untreated follow-up period were considered non-responders in the analysis.


  2. Percentage of Participants With a Sustained Virologic Response 24 Weeks After Actual End of Treatment [ Time Frame: 24 weeks after actual end of treatment (range from Week 48 to Week 72). ]
    Sustained virological response (SVR) is defined as a single last HCV RNA measurement <15 IU/ml (measured using the Roche COBAS AmpliPrep / COBAS TaqMan HCV Test) at 24 weeks after actual end of study treatment. For participants in the 48-week treatment group who stopped study treatment prior to Week 48 for any reason, the HCV RNA measurements 24 weeks after actual end of treatment were used in the analysis. Participants without a 24-week post treatment measurement are considered non-responders.


Secondary Outcome Measures :
  1. Percentage of Participants With Virological Response 72 Weeks After Treatment Initiation [ Time Frame: Week 72 ]

    Virological response 72 weeks after treatment initiation is defined as the percentage of participants with HCV RNA <15 IU/mL as measured by the Roche COBAS AmpliPrep / COBAS TaqMan® HCV Test at 48 weeks post completion of the 24 week treatment period and 24 weeks post completion of the 48 week treatment period.

    Participants without Week 72 measurements were considered non-responders in the analysis.


  2. Percentage of Participants With Virological Response at End of Treatment [ Time Frame: End of Treatment (Week 24 and Week 48 for each treatment group respectively). ]
    Virological response at the end of treatment was defined as the percentage of participants with HCV RNA <15 IU/mL as measured by the Roche COBAS AmpliPrep / COBAS TaqMan® HCV Test after the last dose of study medication.

  3. Percentage of Participants With Virological Relapse [ Time Frame: End of treatment (Weeks 24 or 48) and 24 weeks after the end of treatment (weeks 48 and 72 in each treatment group respectively). ]

    Virological relapse defined as the percentage of participants with a virological response at end of treatment but who did not have a sustained virological response 24 weeks after the end of treatment.

    Virological response at end of treatment is defined as a single last HCV RNA measurement <15 IU/ml measured using the Roche COBAS AmpliPrep / COBAS TaqMan HCV Test at the day of last dose of study medication.

    Sustained virological response 24 weeks after the actual treatment end (SVR24) is defined as a single last HCV RNA measurement <15 IU/ml at least 20 weeks after treatment end.


  4. Percentage of Participants With a Sustained Virologic Response 12 Weeks After Actual End of Treatment [ Time Frame: 12 weeks after actual end of treatment (range from Week 36 to Week 60) ]
    Sustained virological response (SVR) is defined as a single last HCV RNA measurement <15 IU/ml (measured using the Roche COBAS AmpliPrep / COBAS TaqMan HCV Test) at 12 weeks after actual end of study treatment. For participants in the 48-week treatment group who stopped study treatment prior to Week 48 for any reason, the HCV RNA measurements 12 weeks after actual end of treatment were used in the analysis. Participants without a 12-week post treatment measurement are considered non-responders.

  5. Number of Participants With Adverse Events (AEs) [ Time Frame: From Week 1 through Week 72. ]
    An AE was defined as a sign or symptom, including intercurrent illness, that occurred during the course of the clinical study after treatment had started. A related AE is an event assessed by the Investigator to be remotely, possibly, or probably related to study treatment according to criteria provided in the protocol. A severe AE was an event graded by the Investigator as "incapacitating with inability to work or perform normal daily activity". A serious AE (SAE) was defined as any experience that suggests a significant hazard, contraindication, side effect or precaution. This includes any experience which was fatal; was life-threatening; required inpatient hospitalization or prolongation of an existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/ birth defect; was medically significant or required intervention to prevent one or other of the outcomes listed above.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • serological evidence of chronic hepatitis C (CHC);
  • CHC genotype 2 or 3;
  • receiving PEGASYS + Copegus according to local standard of care and no rapid viral response (RVR);
  • compensated liver disease.

Exclusion Criteria:

  • pegylated interferon, standard interferon or ribavirin therapy at any time prior to initiation of current therapy with PEGASYS + Copegus;
  • coinfection with hepatitis A or B, or human immunodeficiency virus (HIV);
  • history or other evidence of decompensated liver disease.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00623428


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Locations
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United States, Alabama
Birmingham, Alabama, United States, 35294
United States, California
La Jolla, California, United States, 92037-1030
Lancaster, California, United States, 93534
Long Beach, California, United States, 90822
Los Angeles, California, United States, 90048
Los Angeles, California, United States, 90057
Sacramento, California, United States, 95816
Sacramento, California, United States, 95817
San Diego, California, United States, 92103-8465
Torrance, California, United States, 90505
United States, Colorado
Aurora, Colorado, United States, 80045
United States, Florida
Jacksonville, Florida, United States, 32256
Orlando, Florida, United States, 32803
United States, Georgia
Atlanta, Georgia, United States, 30308
Marietta, Georgia, United States, 30060
United States, Hawaii
Honolulu, Hawaii, United States, 96813
United States, Louisiana
Baton Rouge, Louisiana, United States, 70890
Opelousas, Louisiana, United States, 70520
United States, Massachusetts
Boston, Massachusetts, United States, 02114
United States, Mississippi
Tupelo, Mississippi, United States, 38801
United States, Missouri
St Louis, Missouri, United States, 63104
St Louis, Missouri, United States, 63110
United States, New Jersey
Egg Harbour Township, New Jersey, United States, 08234
Hackensack, New Jersey, United States, 07601
United States, New Mexico
Albuquerque, New Mexico, United States, 87131
United States, New York
New York, New York, United States, 10016
Syracuse, New York, United States, 13210
United States, North Carolina
Asheville, North Carolina, United States, 28801
Chapel Hill, North Carolina, United States, 27599-7080
Winston-salem, North Carolina, United States, 27103
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73112-4481
United States, Oregon
Portland, Oregon, United States, 97239
United States, Tennessee
Kingsport, Tennessee, United States, 37660
United States, Texas
Fort Sam Houston, Texas, United States, 78234-3879
United States, Utah
Salt Lake City, Utah, United States, 84132
United States, Virginia
Charlottesville, Virginia, United States, 22908
Fairfax, Virginia, United States, 22031
Richmond, Virginia, United States, 23249
Australia
Darlinghurst, Australia, 2010
Fremantle, Australia, 6160
Melbourne, Australia, 3186
Nedlands, Australia, 6009
Sydney, Australia, 2139
Austria
Graz, Austria, 8036
Innsbruck, Austria, 6020
Linz, Austria, 4010
Oberndorf, Austria, 5110
Wien, Austria, 1090
Wien, Austria, 1160
Belgium
Antwerpen, Belgium, 2650
Bruxelles, Belgium, 1000
Bruxelles, Belgium, 1020
Bruxelles, Belgium, 1070
Gent, Belgium, 9000
Kortrijk, Belgium, 8500
Liege, Belgium, 4000
Brazil
Brasilia, Brazil, 70335-000
Campinas, Brazil, 13012-970
Campinas, Brazil, 13081-970
Porto Alegre, Brazil, 90020-090
Porto Alegre, Brazil, 90035-003
Ribeirao Preto, Brazil, 14049-900
Rio de Janeiro, Brazil, 20020-022
Santo Andre, Brazil, 09060-650
Sao Luis, Brazil, 78048-790
Sao Paulo, Brazil, 04040-003
Sorocaba, Brazil, 18047-600
Vitoria, Brazil, 29043-260
Canada, Alberta
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
Vancouver, British Columbia, Canada, V6Z 2K5
Canada, Ontario
Hamilton, Ontario, Canada, L8N 4A6
Mississauga, Ontario, Canada, L5M 4N4
Germany
Berlin, Germany, 10969
Berlin, Germany, 13353
Bonn, Germany, 53127
Düsseldorf, Germany, 40225
Düsseldorf, Germany, 40237
Frankfurt Am Main, Germany, 60590
Freiburg, Germany, 79106
Giessen, Germany, 35392
Hamburg, Germany, 20099
Heidelberg, Germany, 69120
Jena, Germany, 07747
Kiel, Germany, 24105
Köln, Germany, 50937
Mainz, Germany, 55101
München, Germany, 81675
Offenburg, Germany, 77654
Tübingen, Germany, 72076
ULM, Germany, 89081
Mexico
Guadalajara, Mexico, 44160
Guadalajara, Mexico, 44670
Mexicali, Mexico, 21000
Mexico City, Mexico, 14050
Mexico Df, Mexico, 11649
Puebla, Mexico, 72560
Puerto Rico
Santurce, Puerto Rico, 00909
Switzerland
Lausanne, Switzerland, 1005
Lugano, Switzerland, 6903
St. Gallen, Switzerland, 9007
Zürich, Switzerland, 8091
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00623428     History of Changes
Other Study ID Numbers: MV21371
2007-004993-15
First Posted: February 26, 2008    Key Record Dates
Results First Posted: June 24, 2013
Last Update Posted: July 22, 2013
Last Verified: July 2013
Additional relevant MeSH terms:
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Interferons
Ribavirin
Interferon-alpha
Interferon alpha-2
Peginterferon alfa-2a
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs