Clinical trial NCT02562742: Use-Results Surveillance Study of Sovaldi® Plus Rebetol® in Japanese Patients With Chronic Genotype 2 Hepatitis C Virus Infection
Official title: A Prospective Observational Post-Marketing Study of Sovaldi® Plus Rebetol® in Japanese Patients With Chronic Genotype 2 Hepatitis C Virus Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C
Keywords: Hepatitis C virus
observational
post-marketing
sofosbuvir
Infection
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2015-09-29
Enrollment: 554
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with serogroup 2 (genotype 2) chronic HCV infection with or without compensated cirrhosis who take SOF+REB as part of routine clinical care at a participating clinical site.

Brief summary: This use-results post-marketing surveillance (PMS) study for Sovaldi® tablets (sofosbuvir, SOF) administered in combination with Rebetol® capsules (ribavirin, REB) 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.


Eligibility criteria: Key Inclusion Criteria:

* Adult patients with serogroup 2 (genotype 2) chronic HCV infection with or without compensated cirrhosis
* Patients who are prescribed SOF+REB

Key Exclusion Criteria:

* None

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Incidence of adverse drug reaction (ADR) under real world settings
timeFrame: Up to 16 weeks
Secondary outcomes:
measure: Proportion of participants with sustained virologic response (SVR) 12 and 24 weeks after discontinuation of therapy (SVR12 and SVR24)
timeFrame: Posttreatment Weeks 12 and 24
measure: Proportion of participants with HCV NS5B resistance associated variants among patients who do not achieve SVR at 12 weeks
timeFrame: Approximately 12 weeks after treatment completion or discontinuation
Other outcomes:
Locations:
city: Ageo-shi
country: Japan
city: Bunkyo-ku
country: Japan
city: Chuo-shi
country: Japan
city: Fujioka-shi
country: Japan
city: Fukui-shi
country: Japan
city: Fukuoka-shi
country: Japan
city: Hakodate-shi
country: Japan
city: Handa-shi
country: Japan
city: Ichihara-shi
country: Japan
city: Inashiki-gun
country: Japan
city: Iruma-gun
country: Japan
city: Kamogawa-shi
country: Japan
city: Karatsu-shi
country: Japan
city: Kashiwa-shi
country: Japan
city: Katsushika-ku
country: Japan
city: Kawagoe-shi
country: Japan
city: Kawasaki-shi
country: Japan
city: Kitamoto-shi
country: Japan
city: Kobe-shi
country: Japan
city: Kodaira-shi
country: Japan
city: Koto-ku
country: Japan
city: Kurume-shi
country: Japan
city: Kyoto-shi
country: Japan
city: Matsue-shi
country: Japan
city: Matsuyama-shi
country: Japan
city: Minato-ku
country: Japan
city: Miyazaki-shi
country: Japan
city: Morioka-shi
country: Japan
city: Nagoya-shi
country: Japan
city: Osaka-shi
country: Japan
city: Osakasayama-shi
country: Japan
city: Saitama-shi
country: Japan
city: Sakai-shi
country: Japan
city: Sapporo-shi
country: Japan
city: Shibuya-ku
country: Japan
city: Shimotsuke-shi
country: Japan
city: Shinjuku-ku
country: Japan
city: Sumida-ku
country: Japan
city: Tagawa-shi
country: Japan
city: Tondabayashi-shi
country: Japan
city: Toyama-shi
country: Japan
city: Toyoake-shi
country: Japan
city: Utsunomiya-shi
country: Japan
city: Yanagawa-shi
country: Japan
city: Yokohama-shi
country: Japan
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: