Hepatitis C Clinical Trial
Official title:
Usefulness of Adding Thalidomide to Peginterferon and Ribavirin in Patients With Hepatitis C and Resistance to Interferon. Phase II
INDICATION:
Patients with chronic hepatitis C, genotype 1 and non-responders to standard treatment for
hepatitis C.
OBJECTIVES:
1. ascertain the rate of sustained response in patients with hepatitis C, genotype 1 with
peginterferon + ribavirin resistance.
2. To know the response rate in 12 weeks
3. Describe the tolerance and safety of thalidomide in combination with peginterferon and
ribavirin.
DESIGN OF TEST Pilot Study:
The single arm study will:
1. Thalidomide 200 mg and peg-interferon alfa 2b (based on weight: 50-120 mcg / week) +
ribavirin (based on weight: 1000-1200mg / day)
Be tracked for 24 weeks after treatment.
Suspended treatment of 12 weeks in patients who have failed a drop of HCV RNA> 2 log.
Patients who have been suspended for any reason, the treatment will be followed during 24
weeks, to assess safety parameters.
SUBJECT NUMBER: 10
n/a
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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