Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-26 @ 2:09 PM
Study NCT ID:
NCT00856804
Status:
UNKNOWN
Last Update Posted:
2009-03-06
First Post:
2009-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thalidomide Plus Peginterferon and Ribavirin in Patients With Interferon Resistance
Sponsor:
Valme University Hospital
Organization:
Study Overview
Official Title:
Usefulness of Adding Thalidomide to Peginterferon and Ribavirin in Patients With Hepatitis C and Resistance to Interferon. Phase II
Status:
UNKNOWN
Status Verified Date:
2009-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRITAL
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: