Hepatitis C Virus Infection Clinical Trial
Official title:
14 vs 24 Weeks HCV Treatment to Genotype 2/3 Patients With Rapid Virological Response
Patients with HCV genotype 2 or 3 infection who have a rapid virological response to treatment are randomised to either 14 or 24 weeks HCV treatment. Our hypothesis is that there is no important difference in effect between the two treatment effect.
Patients with HCV genotype 2 or 3 infection are currently recommended 6 months treatment
with pegylated interferon alfa (2a or 2b) and ribavirin.Approximately 80% obtain sustained
virological response (HCV RNA undetectable 6 months after treatment) to this approach.
However, the treatment is associated with many and sometimes serious side effects. In
addition, the treatment is costly also in econimical terms. Increasing the treatment
duration beyond 6 months does not increase the response rate. Shorter treatment has only
been assessed in small trials, but the results have been encouraging.
In this randomised, open label,multicenter phase 3 trial with acitive controls patients are
treated with pegylated interferon alfa 2a (PegIntron (R), Schering Plough NJ)(1,5 mcg/kg)and
ribavirin (Rebetol (R), Schering Plough, NJ) (800-1400mg based on weight)for 4 weeks. Those
who are HCV RNA negative at week 4 (<50 IU; Cobas Amplicor Monitor Test, Roche Diagnostic)
are defined as rapid virological responders and randomised to either an additional 10 or 20
weeks combination treatment. Patients who are HCV RNA positive are all treated for 20 more
weeks. The endpoint is sustained virological response defined as undetectable HCV RNA 24
weeks after end of treatment.
Our hypothesis is that there is no important difference in the effect in the two groups.
This is a non-inferiority trial. The smallest difference considered to be clinically
important is 10%. Thus to state "non-inferiority" the 95% confidence interval of the
observed difference between the groups shall not overlap 10%. Both intention to treat and
and per protocol analyses will be published. Conclusion will be conservative and based on
the analysis who detect the biggest difference.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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