Clinical trial NCT02591277: Use-Results Surveillance Study of Harvoni® in Japanese Patients With Chronic Genotype 1 Hepatitis C Virus Infection
Official title: A Prospective Observational Post-Marketing Study of Harvoni in Japanese Patients With Genotype 1 Chronic Hepatitis C Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C
Keywords: Hepatitis C virus
observational
post-marketing
ledipasvir/sofosbuvir
Japan
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2015-10-29
Enrollment: 3294
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 chronic genotype 1 HCV infection with or without compensated cirrhosis who take Harvoni as part of routine clinical care at a participating clinic/hospital.

Brief summary: This study will evaluate the safety and efficacy of Harvoni® (ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC)) treatment under real world use in Japan. Among adult patients with chronic genotype 1 hepatitis C virus (HCV) infection and treated with Harvoni 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 chronic genotype 1 HCV infection with or without compensated cirrhosis
* Patients who are prescribed Harvoni

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 NS5A and 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: Akita-shi
country: Japan
city: Amagasaki-shi
country: Japan
city: Aomori-shi
country: Japan
city: Arao-shi
country: Japan
city: Asahi-shi
country: Japan
city: Asahikawa-shi
country: Japan
city: Asakura-shi
country: Japan
city: Bunkyo-ku
country: Japan
city: Chiba-shi
country: Japan
city: Chichibu-shi
country: Japan
city: Chuo-shi
country: Japan
city: Fujioka-shi
country: Japan
city: Fukui-shi
country: Japan
city: Fukuoka-shi
country: Japan
city: Gifu-shi
country: Japan
city: Hakodate-shi
country: Japan
city: Hamamatsu-shi
country: Japan
city: Handa-shi
country: Japan
city: Hashima-shi
country: Japan
city: Hatsukaichi-shi
country: Japan
city: Higashiibaraki-gun
country: Japan
city: Hirosaki-shi
country: Japan
city: Hiroshima-shi
country: Japan
city: Hitachi-shi
country: Japan
city: Hukui-shi
country: Japan
city: Ichikawa-shi
country: Japan
city: Iizuka-shi
country: Japan
city: Ikeda-shi
country: Japan
city: Inashiki-gun
country: Japan
city: Inzai-shi
country: Japan
city: Iruma-gun
country: Japan
city: Ise-shi
country: Japan
city: Iwaki-shi
country: Japan
city: Izumo-shi
country: Japan
city: Izunokuni-shi
country: Japan
city: Kagoshima-shi
country: Japan
city: Kamogawa-shi
country: Japan
city: Kanazawa-shi
country: Japan
city: Karatsu-shi
country: Japan
city: Kashihara-shi
country: Japan
city: Kashiwa-shi
country: Japan
city: Kasukabe-shi
country: Japan
city: Kawagoe-shi
country: Japan
city: Kawaguchi-shi
country: Japan
city: Kawasaki-shi
country: Japan
city: Kirishima-shi
country: Japan
city: Kitakyushu-shi
country: Japan
city: Kitamoto-shi
country: Japan
city: Kobe-shi
country: Japan
city: Kodaira-shi
country: Japan
city: Kofu-shi
country: Japan
city: Komae-shi
country: Japan
city: Komaki-shi
country: Japan
city: Koriyama-shi
country: Japan
city: Koshigaya-shi
country: Japan
city: Koto-ku
country: Japan
city: Kuga-gun
country: Japan
city: Kuki-shi
country: Japan
city: Kumamoto-shi
country: Japan
city: Kurashiki-shi
country: Japan
city: Kure-shi
country: Japan
city: Kurume-shi
country: Japan
city: Kyoto-shi
country: Japan
city: Maebashi-shi
country: Japan
city: Matsumoto-shi
country: Japan
city: Matsuyama-shi
country: Japan
city: Minato-ku
country: Japan
city: Miyazaki-shi
country: Japan
city: Moriguchi-shi
country: Japan
city: Morioka-shi
country: Japan
city: Nagakute-shi
country: Japan
city: Nagasaki-shi
country: Japan
city: Nagoya-shi
country: Japan
city: Nakagami-gun
country: Japan
city: Nerima-ku
country: Japan
city: Niigata-shi
country: Japan
city: Nishinomiya-shi
country: Japan
city: Noshiro-shi
country: Japan
city: Obihiro-shi
country: Japan
city: Ogi-shi
country: Japan
city: Oita-shi
country: Japan
city: Okayama-shi
country: Japan
city: Omihachiman-shi
country: Japan
city: Osaka-shi
country: Japan
city: Osakasayama-shi
country: Japan
city: Ota-ku
country: Japan
city: Otsu-shi
country: Japan
city: Oume-shi
country: Japan
city: Saga-shi
country: Japan
city: Saitama-shi
country: Japan
city: Sakai-shi
country: Japan
city: Sano-shi
country: Japan
city: Sapporo-shi
country: Japan
city: Sasebo-Shi
country: Japan
city: Sendai-shi
country: Japan
city: Shimonoseki-shi
country: Japan
city: Shimotsuga-gun
country: Japan
city: Shimotsuke-shi
country: Japan
city: Shinagawa-ku
country: Japan
city: Shinjuku-ku
country: Japan
city: Shirakawa-shi
country: Japan
city: Shizuoka-shi
country: Japan
city: Shunan-shi
country: Japan
city: Sumida-ku
country: Japan
city: Tagawa-shi
country: Japan
city: Takamatsu-shi
country: Japan
city: Takasaki-shi
country: Japan
city: Toda-shi
country: Japan
city: Tokorozawa-shi
country: Japan
city: Tokushima-shi
country: Japan
city: Tonami-shi
country: Japan
city: Toyama-shi
country: Japan
city: Toyoake-shi
country: Japan
city: Ureshino-shi
country: Japan
city: Utsunomiya-shi
country: Japan
city: Wakayama-shi
country: Japan
city: Yachiyo-shi
country: Japan
city: Yamagata-shi
country: Japan
city: Yanagawa-shi
country: Japan
city: Yatsushiro-shi
country: Japan
city: Yokkaichi-shi
country: Japan
city: Yokohama-shi
country: Japan
city: Yonago-shi
country: Japan
city: Yoshida-gun
country: Japan
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References:
citation: Mizokami M, Liu LJ, Fujiyama N, Littman M, Yuan J, Sekiya T, Hedskog C, Ng LJ. Real-world safety and effectiveness of ledipasvir/sofosbuvir for the treatment of chronic hepatitis C virus genotype 1 in Japan. J Viral Hepat. 2021 Jan;28(1):129-141. doi: 10.1111/jvh.13395. Epub 2020 Sep 16.