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A Prospective Observational Post-Marketing Study of Sovaldi® Plus Copegus® in Japanese Patients With Chronic Genotype 2 Hepatitis C Virus Infection
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 SOF+ribavirin in routine clinical use, the primary objective of this study is to evaluate the incidence of adverse drug reactions (ADRs) under real world settings.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Amagasaki-shi, Japan
Asahi-shi, Japan
Asahikawa-shi, Japan
Beppu-shi, Japan
Chichibu-shi, Japan
Fujioka-shi, Japan
Fukui-shi, Japan
Hamamatsu, Japan
Iizuka-shi, Japan
Inzai-shi, Japan
Start Date
September 15, 2015
Primary Completion Date
June 5, 2017
Completion Date
June 5, 2017
Last Updated
June 27, 2017
552
ACTUAL participants
SOF
DRUG
COPE
DRUG
Lead Sponsor
Gilead Sciences
Collaborators
NCT05361603
NCT05975216
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05071261