Clinical trial NCT00800748: A Study of Combination Treatment With Peginterferon Alfa-2a (Pegasys) Plus Ribavirin (Copegus) in Participants With Chronic Hepatitis C
Official title: An Open, Phase IV, Multicentric Study, Evaluating Safety and Efficacy of Ribavirin (Copegus®) and Peginterferon Alfa-2a (Pegasys®) Combination in Specific Groups
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis C, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-12-02
Enrollment: 372
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Percentage of Participants With Sustained Virological Response
timeFrame: Up to 72 weeks
Secondary outcomes:
measure: Percentage of Participants With End-of-Treatment Virological Response
timeFrame: Up to 48 weeks
measure: Percentage of Participants With Early-Treatment Virological Response
timeFrame: Up to 12 weeks
measure: Percentage of Participants With Adverse Events
timeFrame: Up to 72 weeks
Other outcomes:
Locations:
city: Beroun
country: Czechia
city: Brno
country: Czechia
city: Ceska Lipa
country: Czechia
city: Ceské Budejovice
country: Czechia
city: Chomutov
country: Czechia
city: Decin
country: Czechia
city: Havirov
country: Czechia
city: Havlickuv Brod
country: Czechia
city: Hradec Kralove
country: Czechia
city: Hradec Kralove
country: Czechia
city: Jablonec/nisou
country: Czechia
city: Jihlava
country: Czechia
city: Karlovy Vary
country: Czechia
city: Kolin
country: Czechia
city: Liberec
country: Czechia
city: Melnik
country: Czechia
city: Most
country: Czechia
city: Olomouc
country: Czechia
city: Opava
country: Czechia
city: Ostrava
country: Czechia
city: Pardubice
country: Czechia
city: Praha 2
country: Czechia
city: Praha
country: Czechia
city: Praha
country: Czechia
city: Praha
country: Czechia
city: Praha
country: Czechia
city: Prostejov
country: Czechia
city: Usti Nad Labem
country: Czechia
city: Banska Bystrica
country: Slovakia
city: Bratislava
country: Slovakia
city: Bratislava
country: Slovakia
city: Kosice
country: Slovakia
city: Kosice
country: Slovakia
city: Martin
country: Slovakia
city: Trencin
country: Slovakia
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: