Thalidomide Plus Peginterferon and Ribavirin in Patients With Interferon Resistance

Summary

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

Timeline

Start

2009-03

Primary completion

2009-06

Completion

2012-06

Drugs

Indications