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

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ClinicalTrials.gov Identifier: NCT00922779
Recruitment Status : Completed
First Posted : June 17, 2009
Results First Posted : January 20, 2016
Last Update Posted : January 20, 2016
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hepatitis C, Chronic Drug: peginterferon alfa-2a [Pegasys] Drug: ribavirin Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6661 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2002
Primary Completion Date : June 2012
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 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)

Primary Outcome Measures :
  1. 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) ]
    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 :
  1. 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) ]
    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.

  2. 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 ]
    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.

  3. 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) ]
    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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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00922779

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Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00922779     History of Changes
Other Study ID Numbers: ML16709
First Posted: June 17, 2009    Key Record Dates
Results First Posted: January 20, 2016
Last Update Posted: January 20, 2016
Last Verified: December 2015

Additional relevant MeSH terms:
Hepatitis C, Chronic
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Peginterferon alfa-2a
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs