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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00412334
First received: December 15, 2006
Last updated: April 7, 2014
Last verified: April 2014

December 15, 2006
April 7, 2014
January 2007
September 2010   (final data collection date for primary outcome measure)
Sustained viral response [ Time Frame: Week 72 ] [ Designated as safety issue: No ]
Sustained viral response at week 72.
Complete list of historical versions of study NCT00412334 on ClinicalTrials.gov Archive Site
  • Percentage of patients with >=2log drop of HCV-RNA [ Time Frame: Week 4, 12, 24. ] [ Designated as safety issue: No ]
  • Percentage of patients with non-detectable HCV-RNA [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  • Relapse rate [ Time Frame: Throughout study. ] [ Designated as safety issue: No ]
Efficacy: percentage of patients with >=2 log drop in HCV-RNA at weeks 4, 12 & 24; percentage of patients with undetectable HCV-RNA at end of treatment; relapse rate. Safety: AEs, lab parameters. QoL: HQLW, fatigue syndrome scale.
Not Provided
Not Provided
 
SYREN Study: A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus Copegus (Ribavirin) in Non-Responder Patients With Chronic Hepatitis C (CHC) Genotype 1.
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatitis C, Chronic
  • Drug: Copegus
    1200-1600mg/day po
  • Drug: peginterferon alfa-2a [Pegasys]
    360 micrograms sc weekly
  • Drug: Copegus
    1000-1200mg/day po
  • Drug: peginterferon alfa-2a [Pegasys]
    180 micrograms sc twice weekly
  • Experimental: 1
    Interventions:
    • Drug: peginterferon alfa-2a [Pegasys]
    • Drug: Copegus
  • Experimental: 2
    Interventions:
    • Drug: Copegus
    • Drug: peginterferon alfa-2a [Pegasys]
  • Experimental: 3
    Interventions:
    • Drug: Copegus
    • Drug: peginterferon alfa-2a [Pegasys]
  • Experimental: 4
    Interventions:
    • Drug: Copegus
    • Drug: peginterferon alfa-2a [Pegasys]
Chevaliez S, Hézode C, Soulier A, Costes B, Bouvier-Alias M, Rouanet S, Foucher J, Bronowicki JP, Tran A, Rosa I, Mathurin P, Alric L, Leroy V, Couzigou P, Mallat A, Charaf-Eddine M, Babany G, Pawlotsky JM. High-dose pegylated interferon-α and ribavirin in nonresponder hepatitis C patients and relationship with IL-28B genotype (SYREN trial). Gastroenterology. 2011 Jul;141(1):119-27. doi: 10.1053/j.gastro.2011.03.039. Epub 2011 Mar 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
104
September 2010
September 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00412334
ML20399
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
April 2014

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