Thalidomide Plus Peginterferon and Ribavirin in Patients With Interferon Resistance (TRITAL)
Recruitment status was Recruiting
Patients with chronic hepatitis C, genotype 1 and non-responders to standard treatment for hepatitis C.
- ascertain the rate of sustained response in patients with hepatitis C, genotype 1 with peginterferon + ribavirin resistance.
- To know the response rate in 12 weeks
- 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 Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Usefulness of Adding Thalidomide to Peginterferon and Ribavirin in Patients With Hepatitis C and Resistance to Interferon. Phase II|
- Virological response at week 12 [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
- Sustained virological response 24 weeks after the end of therapy [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
- Safety of using thalidomide together with SOC. [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2009|
|Estimated Study Completion Date:||June 2012|
|Estimated Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
thalidomide added to peg-interferon + ribavirina
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.
Other Name: thalidomide adding to peginterferon + ribavirin
|Contact: Manuel Romero-Gomez, M.D.Ph.D||+34 955 firstname.lastname@example.org|
|Hospital de Valme||Recruiting|
|Sevilla, Spain, 41014|
|Contact: Manuel Romero-Gomez, M.D. Ph.D +34 955015761 email@example.com|
|Principal Investigator:||Manuel Romero-Gomez, Prof.||Valme University Hospital|