Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:47 AM
Study NCT ID:
NCT01884402
Status:
COMPLETED
Last Update Posted:
2014-09-04
First Post:
2013-06-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Observational,Prospective Study to Develop and Validate a Prognostic Tool to Optimize Therapy in Patients With HCV G1/4
Sponsor:
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Organization:
Study Overview
Official Title:
Observational,Post-authorization Prospective Study to Develop and Validate a Prognostic Tool for Optimizing Therapy in Patients With Hepatitis C Virus (HCV) Genotype 1 and 4.
Status:
COMPLETED
Status Verified Date:
2014-09
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:
OPTIM
Brief Summary:
Primary objective:
• Develop and validate a tool towards patients with chronic hepatitis C genotype 1 and 4 to allow optimize treatment.
• Develop and validate a tool towards patients with chronic hepatitis C genotype 1 and 4 to allow optimize treatment.
Detailed Description:
This Tool:
1. Predicting the overall impact of prognostic factors (including the new factor of genetic polymorphism of the IL28B) on Sustained Viral Response (SVR).
2. Identify those patients most likely to respond.
3. Therapy and therefore optimize resources
The validation tool will check into clinical practice its predictive power (it will consider its ability to calibrate and discriminate) and make correct inferences and interpretations of the scores obtained when applying.
1. Predicting the overall impact of prognostic factors (including the new factor of genetic polymorphism of the IL28B) on Sustained Viral Response (SVR).
2. Identify those patients most likely to respond.
3. Therapy and therefore optimize resources
The validation tool will check into clinical practice its predictive power (it will consider its ability to calibrate and discriminate) and make correct inferences and interpretations of the scores obtained when applying.
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?: