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A Study of Ribavirin in Combination With PEGASYS (Peginterferon Alfa-2a (40KD))in Patients With Chronic Hepatitis C

Phase 4
Completed
Conditions
Hepatitis C, Chronic
Interventions
Drug: peginterferon alfa-2a [Pegasys]
Registration Number
NCT00922779
Lead Sponsor
Hoffmann-La Roche
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
6661
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
1peginterferon alfa-2a [Pegasys]-
1ribavirin-
Primary Outcome Measures
NameTimeMethod
Number of Participants With Non-Serious Adverse Events (AEs) And Serious Adverse Events (SAEs)From signing of informed consent up to end of study (up to Week 72)

An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants with non-serious AEs were exclusive of serious AEs.

Secondary Outcome Measures
NameTimeMethod
Percentage of Participants With Sustained Virological Response (SVR) at 24 Weeks After End of Therapy24 weeks after end of therapy (Week 72)

SVR at 24 weeks after end of therapy was defined as a negative result of HCV Ribonucleic Acid (HCV RNA) qualitative assay 24 weeks after end of therapy. Percentage of participants with SVR was calculated as \[number of participants with negative results of HCV RNA qualitative assay 24 weeks after end of therapy divided by the total number of participants analyzed\] multiplied by 100. The participants who failed to undergo tests at 24 weeks after completion of therapy were considered not amenable to therapy.

Percentage of Participants With Undetectable HCV RNA at Weeks 12, 24 and 48 After Therapy InitiationWeeks 12,24 and 48 After Therapy Initiation

HCV RNA levels of \< 50 International Units per milliliter (IU/mL) were defined as undetectable HCV RNA. The percentage of participants with undetectable HCV RNA was calculated as \[number of participants with undetectable HCV RNA divided by the total number of participants analyzed\] multiplied by 100 for Weeks 12, 24 and 48.

Percentage of Participants With Change in Hemoglobin LevelBaseline, Weeks 2, 4, 8, 12, 24, 36, 48 and follow-up Weeks 4 (Week 52), 12 (Week 60), and 24 (Week 72)

Change in hemoglobin level (compared to baseline) was reported as "significant decrease", "Normal" (no change), "Increase", "Decrease", and "Missing". Significant decrease was defined as per Investigator's discretion.

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