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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00922779
First received: June 16, 2009
Last updated: December 11, 2015
Last verified: December 2015

June 16, 2009
December 11, 2015
June 2002
June 2012   (final data collection date for primary outcome measure)
Number of Participants With Non-Serious Adverse Events (AEs) And Serious Adverse Events (SAEs) [ Time Frame: From signing of informed consent up to end of study (up to Week 72) ] [ Designated as safety issue: No ]
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.
Adverse events; laboratory parameters [ Time Frame: Throughout study; recorded at each clinic visit ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00922779 on ClinicalTrials.gov Archive Site
  • Percentage of Participants With Sustained Virological Response (SVR) at 24 Weeks After End of Therapy [ Time Frame: 24 weeks after end of therapy (Week 72) ] [ Designated as safety issue: No ]
    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 Initiation [ Time Frame: Weeks 12,24 and 48 After Therapy Initiation ] [ Designated as safety issue: No ]
    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 Level [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 24, 36, 48 and follow-up Weeks 4 (Week 52), 12 (Week 60), and 24 (Week 72) ] [ Designated as safety issue: No ]
    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.
Sustained viral response [ Time Frame: 24 weeks after end of therapy ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of Ribavirin in Combination With PEGASYS (Peginterferon Alfa-2a (40KD))in Patients With Chronic Hepatitis C
Safety and Tolerability of Ribavirin (RO 20-9963) in Combination With Peginterferon Alfa-2a (40 kD)in Patients With Chronic Hepatitis C
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.
Not Provided
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatitis C, Chronic
  • Drug: peginterferon alfa-2a [Pegasys]
    180micrograms sc weekly for 12-48 weeks
  • Drug: ribavirin
    800mg, or 1000-1200mg, po daily (dependent on HCV genotype and body weight)
Experimental: 1
Interventions:
  • Drug: peginterferon alfa-2a [Pegasys]
  • Drug: ribavirin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6661
June 2012
June 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Russian Federation
 
NCT00922779
ML16709
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
December 2015

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