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A Study of Combination Therapy With PEGASYS (Peginterferon Alfa-2a (40KD)) and Copegus (Ribavirin) in Patients With Chronic Hepatitis C Genotype 2 or 3 Who Do Not Achieve a Rapid Viral Response.
This study is currently recruiting participants.
Study NCT00623428   Information provided by Hoffmann-La Roche
First Received: February 18, 2008   Last Updated: November 20, 2009   History of Changes

February 18, 2008
November 20, 2009
April 2008
 
SVR [ Time Frame: 24 weeks post-treatment (week 48 for Group 1, and week 72 for Group 2). ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00623428 on ClinicalTrials.gov Archive Site
  • Percentage of patients with non-detectable HCV-RNA [ Time Frame: End of treatment (week 24 for Group 1 and week 48 for Group 2) ] [ Designated as safety issue: No ]
  • Percentage of patients with >=2 log10 drop in HCV-RNA [ Time Frame: Treatment week 12 ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Same as current
 
A Study of Combination Therapy With PEGASYS (Peginterferon Alfa-2a (40KD)) and Copegus (Ribavirin) in Patients With Chronic Hepatitis C Genotype 2 or 3 Who Do Not Achieve a Rapid Viral Response.
A Randomized, Open-label Study of the Effects of 24 vs 48 Weeks of Combination Therapy With PEGASYS (Peginterferon Alfa-2a 40KD) Plus COPEGUS (Ribavirin) on Sustained Virological Response in Patients With Chronic Hepatitis C, Genotype 2 or 3 Who do Not Achieve a Rapid Viral Response.

This study will evaluate the efficacy and safety of PEGASYS + Copegus combination therapy given for 24 weeks versus 48 weeks in patients with chronic hepatitis C, genotype 2/3. Patients receiving PEGASYS (180 micrograms sc weekly) + Copegus (800-1200mg po daily) who do not achieve a rapid viral response at week 4 will enter the study between treatment week 6 and 8, and will receive study medication. Those who have an early virological response at week 12, and are still taking medication at week 24, will then be randomized to one of 2 study groups. Group 1 will stop treatment at this point and will have a 48 week post-treatment observation period, and Group 2 will stay on medication for a further 24 weeks, followed by a 24 week post-treatment observation period. The anticipated time on study treatment is 6-12 months, and the target sample size is 100-500 individuals.

 
Phase III
Interventional
Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Hepatitis C, Chronic
  • Drug: peginterferon alfa-2a (40KD) [PEGASYS]
  • Drug: peginterferon alfa-2a [PEGASYS]
  • Drug: Copegus
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
400
August 2011
 

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • serological evidence of chronic hepatitis C (CHC);
  • CHC genotype 2 or 3;
  • receiving PEGASYS + Copegus according to local standard of care and no RVR;
  • compensated liver disease.

Exclusion Criteria:

  • pegylated interferon, standard interferon or ribavirin therapy at any time prior to initiation of current therapy with PEGASYS + Copegus;
  • coinfection with hepatitis A or B, or HIV;
  • history or other evidence of decompensated liver disease.
Both
18 Years and older
No
Contact: Please reference Study ID Number: MV21371 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com
United States,   Australia,   Austria,   Belgium,   Brazil,   Canada,   Germany,   Mexico,   Puerto Rico,   Switzerland
 
NCT00623428
Disclosures Group, Hoffmann-La Roche
MV21371, 2007-004993-15
Hoffmann-La Roche
 
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2009

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