Clinical trial NCT02537379: Use-Results Surveillance Study of Sovaldi® Plus Copegus® in Japanese Patients With Chronic Genotype 2 Hepatitis C Virus Infection
Official title: A Prospective Observational Post-Marketing Study of Sovaldi® Plus Copegus® in Japanese Patients With Chronic Genotype 2 Hepatitis C Virus Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C Virus Infection
Keywords: Hepatitis C virus
observational
post-marketing
sofosbuvir
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
Collaborators: name: Chugai Pharmaceutical
First posted: 2015-09-01
Enrollment: 552
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+COPE as part of routine clinical care at a participating clinical site.

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 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+COPE

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: Amagasaki-shi
country: Japan
city: Asahi-shi
country: Japan
city: Asahikawa-shi
country: Japan
city: Beppu-shi
country: Japan
city: Chichibu-shi
country: Japan
city: Fujioka-shi
country: Japan
city: Fukui-shi
country: Japan
city: Hamamatsu-shi
country: Japan
city: Iizuka-shi
country: Japan
city: Inzai-shi
country: Japan
city: Ishinomaki-shi
country: Japan
city: Iwaki-shi
country: Japan
city: Izunokuni-shi
country: Japan
city: Kahoku-gun
country: Japan
city: Kanazawa-shi
country: Japan
city: Kirishima-shi
country: Japan
city: Kisarazu-shi
country: Japan
city: Kitamoto-shi
country: Japan
city: Kobe-shi
country: Japan
city: Koshigaya-shi
country: Japan
city: Kure-shi
country: Japan
city: Moriguchi-shi
country: Japan
city: Nagakute-shi
country: Japan
city: Nagaoka-shi
country: Japan
city: Nagasaki-shi
country: Japan
city: Nagoya-shi
country: Japan
city: Nakagami-gun
country: Japan
city: Nanto-shi
country: Japan
city: Nishinomiya-shi
country: Japan
city: Ogi-shi
country: Japan
city: Okayama-shi
country: Japan
city: Ome-shi
country: Japan
city: Osaka-shi
country: Japan
city: Ota-ku
country: Japan
city: Sapporo-shi
country: Japan
city: Sasebo-Shi
country: Japan
city: Sendai-shi
country: Japan
city: Shinagawa-ku
country: Japan
city: Shinjuku-ku
country: Japan
city: Tokorozawa-shi
country: Japan
city: Tokushima-shi
country: Japan
city: Wakayama-shi
country: Japan
city: Yachiyo-shi
country: Japan
city: Yokohama-shi
country: Japan
city: Yufu-shi
country: Japan
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: