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A Study of Combination Treatment With Peginterferon Alfa-2a (Pegasys) Plus Ribavirin (Copegus) in Participants With Chronic Hepatitis C

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ClinicalTrials.gov Identifier: NCT00800748
Recruitment Status : Completed
First Posted : December 2, 2008
Last Update Posted : May 22, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE December 1, 2008
First Posted Date  ICMJE December 2, 2008
Last Update Posted Date May 22, 2017
Actual Study Start Date  ICMJE February 1, 2006
Actual Primary Completion Date January 9, 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 19, 2017)
Percentage of Participants With Sustained Virological Response [ Time Frame: Up to 72 weeks ]
Sustained virological response is defined as having no hepatitis C (HCV) virus detectable in the blood 24 weeks after end of treatment.
Original Primary Outcome Measures  ICMJE
 (submitted: December 1, 2008)
Occurrence rate and intensity of adverse events [ Time Frame: Throughout study ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 19, 2017)
  • Percentage of Participants With End-of-Treatment Virological Response [ Time Frame: Up to 48 weeks ]
    End-of-treatment virological response is defined as having no HCV virus detectable in the blood immediately after end of treatment.
  • Percentage of Participants With Early-Treatment Virological Response [ Time Frame: Up to 12 weeks ]
    Early-treatment virological response is defined as having no HCV virus detectable in the blood or a 2-log (100-fold) decrease in HCV virus concentration in the blood after 12 weeks of study treatment.
  • Percentage of Participants With Adverse Events [ Time Frame: Up to 72 weeks ]
    An adverse event is considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsen during the study are reported as adverse events.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 1, 2008)
  • Sustained viral response [ Time Frame: End of treatment (weeks 24 or 48) ]
  • Viral response rate [ Time Frame: At week 12, and at end of treatment (weeks 24 or 48) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Combination Treatment With Peginterferon Alfa-2a (Pegasys) Plus Ribavirin (Copegus) in Participants With Chronic Hepatitis C
Official Title  ICMJE An Open, Phase IV, Multicentric Study, Evaluating Safety and Efficacy of Ribavirin (Copegus®) and Peginterferon Alfa-2a (Pegasys®) Combination in Specific Groups
Brief Summary This 3-arm study assessed the safety and efficacy of combination treatment with peginterferon alfa-2a + ribavirin in participants with chronic hepatitis C. Three groups of participants were studied; 1) those with elevated alanine transaminase (ALT) levels, 2) those with normal ALT levels, and 3) those with human immunodeficiency virus (HIV) co-infection. Participants with genotype 1, 4, 5 or 6 received peginterferon alfa-2a 180 micrograms (mcg) subcutaneous (SC) once weekly (qw) + ribavirin 1000-1200 milligrams (mg) orally (PO) daily (dependent on body weight) for 48 weeks. Those with genotype 2 or 3 received peginterferon alfa-2a 180 mcg SC qw + ribavirin 800 mg PO daily for 24 weeks, and all participants with HIV co-infection received peginterferon alfa-2a 180 mcg SC qw + ribavirin 800 mg PO daily for 48 weeks.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hepatitis C, Chronic
Intervention  ICMJE
  • Drug: Peginterferon alfa-2a
    Peginterferon alfa-2a was administered at a dose of 180 mcg SC weekly for 48 weeks to participants with genotype 1, 4, 5, 6 and to participants with HIV co-infection, or for 24 weeks to participants with genotype 2 and 3.
    Other Name: Pegasys
  • Drug: Ribavirin
    Ribavirin was administered at a dose of 1000-1200 mg PO daily for 48 weeks to participants with genotype 1, 4, 5, 6 or 800 mg PO daily for 24 weeks to participants with genotype 2 and 3.
    Other Name: Copegus
Study Arms  ICMJE
  • Experimental: Group A
    Participants with genotype 1, 4, 5 or 6 received peginterferon alfa-2a 180 mcg SC qw + ribavirin 1000-1200 mg PO daily (dependent on body weight) for 48 weeks.
    Interventions:
    • Drug: Peginterferon alfa-2a
    • Drug: Ribavirin
  • Experimental: Group B
    Participants with genotype 2 or 3 received peginterferon alfa-2a 180 mcg SC qw + ribavirin 800 mg PO daily for 24 weeks.
    Interventions:
    • Drug: Peginterferon alfa-2a
    • Drug: Ribavirin
  • Experimental: Group C
    Participants with HIV co-infection received peginterferon alfa-2a 180 mcg SC qw + ribavirin 800 mg PO daily for 48 weeks.
    Interventions:
    • Drug: Peginterferon alfa-2a
    • Drug: Ribavirin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 19, 2017)
372
Original Estimated Enrollment  ICMJE
 (submitted: December 1, 2008)
400
Actual Study Completion Date  ICMJE January 9, 2009
Actual Primary Completion Date January 9, 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adult participants at least 18 years of age
  • Chronic hepatitis C, with detectable serum hepatitis C virus (HCV) ribonucleic acid (RNA)
  • Scheduled for treatment with peginterferon alfa-2a
  • Compensated liver disease
  • Women in fertile age must be informed about obligation of using adequate contraception during and 6 months post treatment with ribavirin (Copegus®)
  • Men with a sexual partner in fertile age must be informed about obligatory contraception preventing pregnancy during the course of treatment with ribavirin (Copegus®) as well as 6 months after treatment cessation
  • Female participants in the study must have a negative pregnancy test performed not sooner than within 2 weeks preceding the planned inclusion to the study
  • Men with a sexual partner in fertile age must produce a negative result of the partner's pregnancy test performed not sooner than within 2 weeks preceding the planned partner's inclusion to the study

Exclusion Criteria:

  • Chronic liver disease other than chronic hepatitis C
  • Active hepatitis A virus or hepatitis B virus infection
  • Therapy with any systemic antiviral, antineoplastic or immunomodulatory treatment less than or equal to (<=) 6 months prior to first dose of study drug
  • Hemoglobin <120 grams per liter (g/L) in female participants or <130 g/L in male participants (the result must not be older than 2 weeks prior to inclusion to the study)
  • Platelet count <90 x 10^9/liter (the result must not be older than 2 weeks prior to inclusion to the study
  • Neutrofil count <1.5 x 10^9/liter (the result must not be older than 2 weeks prior to inclusion to the study)
  • Participants with increased risk of anaemia, or participants at risk of serious health problems resulting from anaemia or decrease of hemoglobin (e.g., participants with serious cardiovascular or cerebrovascular disease)
  • History or presence of a serious mental disease, especially depression, which, in the investigator's opinion, does not allow administration of peginterferon alfa-2a (Pegasys®)
  • History or presence of a disease consequent to immunodeficiency (e.g., inflammatory diseases of intestine, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, rheumatoid arthritis)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czechia,   Slovakia
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT00800748
Other Study ID Numbers  ICMJE ML19387
2005-003932-23 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP