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

Hepatitis C, Chronic Clinical Trial

Official title:

Safety and Tolerability of Ribavirin (RO 20-9963) in Combination With Peginterferon Alfa-2a (40 kD)in Patients With Chronic Hepatitis C

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00922779
• Other study ID #: ML16709
• Status: Completed
• Phase: Phase 4
• First received: June 16, 2009
• Last updated: December 11, 2015
• Start date: June 2002
• Est. completion date: June 2012

Study information

• Verified date: December 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6661
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• peginterferon alfa-2a [Pegasys]
180micrograms sc weekly for 12-48 weeks
• ribavirin
800mg, or 1000-1200mg, po daily (dependent on HCV genotype and body weight)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Non-Serious Adverse Events (AEs) And Serious Adverse Events (SAEs)	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.	From signing of informed consent up to end of study (up to Week 72)	No
Secondary	Percentage of Participants With Sustained Virological Response (SVR) at 24 Weeks After End of Therapy	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.	24 weeks after end of therapy (Week 72)	No
Secondary	Percentage of Participants With Undetectable HCV RNA at 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.	Weeks 12,24 and 48 After Therapy Initiation	No
Secondary	Percentage of Participants With Change in Hemoglobin Level	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.	Baseline, Weeks 2, 4, 8, 12, 24, 36, 48 and follow-up Weeks 4 (Week 52), 12 (Week 60), and 24 (Week 72)	No