Ignite Creation Date:
2024-05-05 @ 6:51 PM
Last Modification Date:
2024-10-26 @ 9:37 AM
Study NCT ID:
NCT00553930
Status:
COMPLETED
Last Update Posted:
2010-05-18
First Post:
2007-11-03
Brief Title:
Low Dose Peginterferon-α 2a for Chronic Hepatitis C Genotypes 2 or 3 in HIV-coinfected Patients
Sponsor:
Sociedad Andaluza de Enfermedades Infecciosas
Organization:
Sociedad Andaluza de Enfermedades Infecciosas
Study Overview
Official Title:
Efficacy of Low Dose Pegylated Interferon-α 2a Plus Ribavirin for the Treatment of Chronic Hepatitis C Genotypes 2 or 3 in HIV-coinfected Patients
Status:
COMPLETED
Status Verified Date:
2010-05
Last Known Status:
None
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:
SAEI_IFN_1
Brief Summary:
Hypothesis A regimen of low dose of peginterferon alfa-2a plus ribavirin may be as effective as currently recommended regimen for chronic hepatitis C in HIV-coinfected patients
Objective To evaluate the efficacy of lower dose of pegylated interferon-α 2a 135 µg weekly plus ribavirin and a shorter duration of treatment 20 weeks after achieving an undetectable plasmatic HCV-RNAthan the current recommended in patients with chronic hepatitis or compensated cirrhosis by hepatitis C virus genotypes 2 or 3 in HIV-coinfected patients in real use conditions
Method Phase IV postautorization open labelled multicenter trial with a planned duration of 118 weeks in which 71 patients from several hospitals of the Servicio Andaluz de Salud will be enrolled The usual clinical and analytical follow up will be performed but additional blood samples will be obtained for determination of interferon and ribavirin plasma levels The primary end point wall be a sustained virologic response defined as an undetectable serum HCV-RNA after 24 weeks after the cessation of treatment Likewise rapid virological response at 4 weeks of treatment early virological response at 12 weeks and end of treatment response rates will be evaluated as well as their relationships with the plasma interferon an ribavirin concentrations determined by ELISA and HPLC respectively The safety and tolerability of the studied medications will be evaluated by means of clinical adverse events physical examination and laboratory results
Objective To evaluate the efficacy of lower dose of pegylated interferon-α 2a 135 µg weekly plus ribavirin and a shorter duration of treatment 20 weeks after achieving an undetectable plasmatic HCV-RNAthan the current recommended in patients with chronic hepatitis or compensated cirrhosis by hepatitis C virus genotypes 2 or 3 in HIV-coinfected patients in real use conditions
Method Phase IV postautorization open labelled multicenter trial with a planned duration of 118 weeks in which 71 patients from several hospitals of the Servicio Andaluz de Salud will be enrolled The usual clinical and analytical follow up will be performed but additional blood samples will be obtained for determination of interferon and ribavirin plasma levels The primary end point wall be a sustained virologic response defined as an undetectable serum HCV-RNA after 24 weeks after the cessation of treatment Likewise rapid virological response at 4 weeks of treatment early virological response at 12 weeks and end of treatment response rates will be evaluated as well as their relationships with the plasma interferon an ribavirin concentrations determined by ELISA and HPLC respectively The safety and tolerability of the studied medications will be evaluated by means of clinical adverse events physical examination and laboratory results
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None