Ignite Creation Date:
2024-05-06 @ 7:27 AM
Last Modification Date:
2024-10-26 @ 11:48 AM
Study NCT ID:
NCT02537379
Status:
COMPLETED
Last Update Posted:
2017-06-27
First Post:
2015-08-28
Brief Title:
Use-Results Surveillance Study of Sovaldi Plus Copegus in Japanese Patients With Chronic Genotype 2 Hepatitis C Virus Infection
Sponsor:
Gilead Sciences
Organization:
Gilead Sciences
Study Overview
Official Title:
A Prospective Observational Post-Marketing Study of Sovaldi Plus Copegus in Japanese Patients With Chronic Genotype 2 Hepatitis C Virus Infection
Status:
COMPLETED
Status Verified Date:
2017-06
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:
This post-marketing surveillance PMS study for Sovaldi tablets sofosbuvir SOF administered in combination with Copegus tablets ribavirin COPE will evaluate the safety and efficacy of SOF administered in combination with ribavirin under real world use in Japan Among adult patients with chronic genotype 2 hepatitis C virus HCV infection and treated with SOFribavirin in routine clinical use the primary objective of this study is to evaluate the incidence of adverse drug reactions ADRs under real world settings
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