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

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	Complete list of historical versions of study NCT00800748 on ClinicalTrials.gov Archive Site
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 Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	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	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	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	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	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	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	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