Clinical trial NCT00922779: A Study of Ribavirin in Combination With PEGASYS (Peginterferon Alfa-2a (40KD))in Patients With Chronic Hepatitis C
Official title: Safety and Tolerability of Ribavirin (RO 20-9963) in Combination With Peginterferon Alfa-2a (40 kD)in Patients With Chronic Hepatitis C
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis C, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2009-06-17
Enrollment: 6661
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This single arm study will evaluate the safety and tolerability of ribavirin in combination with PEGASYS in patients with chronic hepatitis C. Patients will receive ribavirin 800mg, or 1000-1200mg po daily, according to HCV genotype and body weight (\< and \>75kg)in combination with PEGASYS 180micrograms sc weekly. The anticipated time on study treatment is 3-12 months, and the target sample size is \>500 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, \>=18 years of age;
* serological evidence of chronic hepatitis C;
* detectable serum HCV-RNA;
* liver biopsy findings consistent with a diagnosis of chronic hepatitis C.

Exclusion Criteria:

* history or other evidence of a medical condition associated with chronic liver disease other than HCV;
* co-infection with active hepatitis A or B;
* hepatocellular carcinoma;
* patients with severe cardiovascular disease whose condition may worsen due to acute anemia.

Primary outcomes:
measure: Number of Participants With Non-Serious Adverse Events (AEs) And Serious Adverse Events (SAEs)
timeFrame: From signing of informed consent up to end of study (up to Week 72)
Secondary outcomes:
measure: Percentage of Participants With Sustained Virological Response (SVR) at 24 Weeks After End of Therapy
timeFrame: 24 weeks after end of therapy (Week 72)
measure: Percentage of Participants With Undetectable HCV RNA at Weeks 12, 24 and 48 After Therapy Initiation
timeFrame: Weeks 12,24 and 48 After Therapy Initiation
measure: Percentage of Participants With Change in Hemoglobin Level
timeFrame: Baseline, Weeks 2, 4, 8, 12, 24, 36, 48 and follow-up Weeks 4 (Week 52), 12 (Week 60), and 24 (Week 72)
Other outcomes:
Locations:
city: Arkhangelsk
country: Russian Federation
city: Barnaul
country: Russian Federation
city: Barnaul
country: Russian Federation
city: Blagoveshchensk
country: Russian Federation
city: Cheboksary
country: Russian Federation
city: Chelyabinsk
country: Russian Federation
city: Chelyabinsk
country: Russian Federation
city: Chelyabinsk
country: Russian Federation
city: Cherepovets
country: Russian Federation
city: Chita
country: Russian Federation
city: Ekaterinburg
country: Russian Federation
city: Ekaterinburg
country: Russian Federation
city: Ekaterinburg
country: Russian Federation
city: Irkutsk
country: Russian Federation
city: Irkutsk
country: Russian Federation
city: Irkutsk
country: Russian Federation
city: Izhevsk
country: Russian Federation
city: Kazan
country: Russian Federation
city: Kemerovo
country: Russian Federation
city: Kemerovo
country: Russian Federation
city: Kemerovo
country: Russian Federation
city: Khabarovsk
country: Russian Federation
city: Khabarovsk
country: Russian Federation
city: Khabarovsk
country: Russian Federation
city: Kirov
country: Russian Federation
city: Krasnodar
country: Russian Federation
city: Krasnodar
country: Russian Federation
city: Krasnodar
country: Russian Federation
city: Krasnoyarsk
country: Russian Federation
city: Krasnoyarsk
country: Russian Federation
city: Lipetsk
country: Russian Federation
city: Makhachkala
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Nizhny Novgorod
country: Russian Federation
city: Novokuznetsk
country: Russian Federation
city: Novokuznetsk
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: Novouralsk
country: Russian Federation
city: Omsk
country: Russian Federation
city: Orenburg
country: Russian Federation
city: Petropavlovsk-Kamchatskiy
country: Russian Federation
city: Rostov-na-donu
country: Russian Federation
city: Salekhard
country: Russian Federation
city: Samara
country: Russian Federation
city: Samara
country: Russian Federation
city: Saratov
country: Russian Federation
city: Saratov
country: Russian Federation
city: Saratov
country: Russian Federation
city: Soshi
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Stavropol
country: Russian Federation
city: Surgut
country: Russian Federation
city: Tjumen
country: Russian Federation
city: Tomsk
country: Russian Federation
city: Tumen
country: Russian Federation
city: Tumen
country: Russian Federation
city: Tumen
country: Russian Federation
city: UFA
country: Russian Federation
city: UFA
country: Russian Federation
city: Ulan-ude
country: Russian Federation
city: Vladivostok
country: Russian Federation
city: Vladivostok
country: Russian Federation
city: Volgograd
country: Russian Federation
city: Volgograd
country: Russian Federation
city: Yakutsk
country: Russian Federation
city: Yujno-sakhalinsk
country: Russian Federation
city: Yujno-sakhalinsk
country: Russian Federation
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: