SYREN Study: A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus Copegus (Ribavirin) in Non-Responder Patients With Chronic Hepatitis C (CHC) Genotype 1.

Hepatitis C, Chronic Clinical Trial

Official title:

Antiviral Effect of 4 Regimens of PEGASYS Plus Copegus in Patients With Genotype 1 Chronic Hepatitis C Non-responder to Previous Peginterferon Alfa-2a Plus Ribavirin Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00412334
• Other study ID #: ML20399
• Status: Completed
• Phase: Phase 4
• First received: December 15, 2006
• Last updated: April 2, 2016
• Start date: January 2007
• Est. completion date: September 2010

Study information

• Verified date: April 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: AFSSAPS (Agence francaise de securite sanitaire des produits de sante)
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the efficacy and safety of 4 regimens of PEGASYS plus Copegus, in patients with chronic hepatitis C (CHC) genotype 1 who have failed to respond to previous treatment with standard doses of PEGASYS plus ribavirin. Patients will be randomized to one of 4 groups, to receive a)PEGASYS 360 micrograms/week plus Copegus 1000-1200mg/day, b)PEGASYS 180 micrograms twice weekly plus Copegus 1000-1200mg/day, c)PEGASYS 360micrograms/week plus Copegus 1200-1600mg/day, or d)PEGASYS 180 micrograms twice weekly plus Copegus 1200-1600mg/day. Following 48 weeks treatment, there will be a 24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patients >=18 years of age, with CHC genotype 1;

• patients who have failed to respond to previous treatment with PEGASYS plus ribavirin for >=12 weeks;

• patients who have discontinued PEGASYS/ribavirin >=4 weeks prior to enrollment;

• compensated liver disease.

Exclusion Criteria:

• other forms of liver disease;

• infection with HIV, HAV, HBV;

• hepatocellular cancer.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• Copegus
1200-1600mg/day po
• Copegus
1000-1200mg/day po
• peginterferon alfa-2a [Pegasys]
360 micrograms sc weekly
• peginterferon alfa-2a [Pegasys]
180 micrograms sc twice weekly

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained viral response		Week 72	No
Secondary	Percentage of patients with >=2log drop of HCV-RNA		Week 4, 12, 24.	No
Secondary	Percentage of patients with non-detectable HCV-RNA		Week 48	No
Secondary	Relapse rate		Throughout study.	No