Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-24 @ 7:58 PM
NCT ID:
NCT00856804
Brief 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
Study:
NCT00856804
Study Brief:
Protocol Section:
NCT00856804