NCT00856804

Thalidomide Plus Peginterferon and Ribavirin in Patients With Interferon Resistance

Usefulness of Adding Thalidomide to Peginterferon and Ribavirin in Patients With Hepatitis C and Resistance to Interferon. Phase II

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Valme University Hospital · Academic / Other
• Sex: All
• Age: 45 Years – 80 Years
• Healthy volunteers: Not accepted

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

Conditions

• Hepatitis C

Interventions

Type	Name	Description
DRUG	thalidomide	Open-label pilot study analyzing the impact of adding thalidomide (200 mg/d)to SOC on 12 weeks virological response in patients with chronic hepatitis C and interferon resistance.

Timeline

• Start date: 2009-03-01
• Primary completion: 2009-06-01
• Completion: 2012-06-01
• First posted: 2009-03-06
• Last updated: 2009-03-06

Locations

1 site across 1 country: Spain