Ignite Creation Date:
2024-05-06 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 12:01 PM
Study NCT ID:
NCT02758509
Status:
COMPLETED
Last Update Posted:
2018-05-21
First Post:
2016-04-26
Brief Title:
Impact of Antiviral Therapy on Gastroesophageal Varices
Sponsor:
Parc de Salut Mar
Organization:
Parc de Salut Mar
Study Overview
Official Title:
Efficacy and Safety of Interferon Based Therapy and Interferon-free Direct-acting Antivirals in Cirrhotic Patients With Hepatitis C Impact of Antiviral Therapy on Gastroesophageal Varices
Status:
COMPLETED
Status Verified Date:
2018-05
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:
None
Brief Summary:
Hepatitis C virus HCV chronic infection affects 200 million people worldwide HCV antiviral treatment has evolved rapidly since 2011 The use of pegylated interferon PEG-INF with ribavirin RBV has supposed high serious adverse events SAEs and low efficacy especially in patients with cirrhosis The introduction of 1st generation protease inhibitors PIs in genotype-1 GT1 HCV such as boceprevir BOC and telaprevir TVR improved the efficacy but increased the SAEs Currently interferon-free direct-acting antivirals IF-DAAs achieve great effectiveness with minimum SAEs However studies evaluating efficacy and safety of DAAs in cirrhotic patients are limited in real clinical practice The aim of our study is to evaluate in HCV-cirrhotic patients the efficacy and safety of 3 treatment strategies PEG-IFNRBV PEG-IFNRBVPIs and IF-DAAs in routine practice according to European guidelines from 2010 to 2015 The secondary aim is to evaluate the impact of sustained virological response on gastroesophageal varices GOV
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