Use-Results Surveillance Study of Harvoni® in Japanese Patients With Chronic Genotype 1 Hepatitis C Virus Infection

NCT ID: NCT02591277

Last Updated: 2019-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3294 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-30

Study Completion Date

2017-11-01

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatitis C

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

PROSPECTIVE

Study Groups

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Harvoni

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.

Harvoni

Intervention Type DRUG

Harvoni (90/400 mg) FDC tablet administered orally once daily

Interventions

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Harvoni

Harvoni (90/400 mg) FDC tablet administered orally once daily

Intervention Type DRUG

Other Intervention Names

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LDV/SOF GS-5885/GS-7977

Eligibility Criteria

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Inclusion Criteria

* Adult patients with chronic genotype 1 HCV infection with or without compensated cirrhosis
* Patients who are prescribed Harvoni

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gilead Sciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gilead Study Director

Role: STUDY_DIRECTOR

Gilead Sciences

Locations

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Ageo-shi, , Japan

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Akita, , Japan

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Amagasaki-shi, , Japan

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Aomori, , Japan

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Arao-shi, , Japan

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Asahi-shi, , Japan

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Asahikawa-shi, , Japan

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Asakura-shi, , Japan

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Bunkyō City, , Japan

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Chiba, , Japan

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Chichibu-shi, , Japan

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Chuo-shi, , Japan

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Fujioka-shi, , Japan

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Fukui-shi, , Japan

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Fukuoka, , Japan

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Gifu, , Japan

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Hakodate-shi, , Japan

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Hamamatsu, , Japan

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Handa-shi, , Japan

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Hashima-shi, , Japan

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Hatsukaichi-shi, , Japan

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Higashiibaraki-gun, , Japan

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Hirosaki-shi, , Japan

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Hiroshima, , Japan

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Hitachi-shi, , Japan

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Hukui-shi, , Japan

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Ichikawa-shi, , Japan

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Iizuka-shi, , Japan

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Ikeda-shi, , Japan

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Inashiki-gun, , Japan

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Inzai-shi, , Japan

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Iruma-gun, , Japan

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Ise-shi, , Japan

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Iwaki, , Japan

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Izumo-shi, , Japan

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Izunokuni-shi, , Japan

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Kagoshima, , Japan

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Kamogawa-shi, , Japan

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Kanazawa, , Japan

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Karatsu-shi, , Japan

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Kashihara-shi, , Japan

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Kashiwa-shi, , Japan

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Kasukabe-shi, , Japan

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Kawagoe-shi, , Japan

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Kawaguchi-shi, , Japan

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Kawasaki-shi, , Japan

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Kirishima-shi, , Japan

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Kitakyushu-shi, , Japan

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Kitamoto-shi, , Japan

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Kobe, , Japan

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Kodaira-shi, , Japan

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Kofu, , Japan

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Komae-shi, , Japan

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Komaki-shi, , Japan

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Koriyama-shi, , Japan

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Koshigaya-shi, , Japan

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Kōtoku, , Japan

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Kuga-gun, , Japan

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Kuki-shi, , Japan

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Kumamoto, , Japan

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Kurashiki-shi, , Japan

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Kure-shi, , Japan

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Kurume-shi, , Japan

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Kyoto, , Japan

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Maebashi, , Japan

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Matsumoto-shi, , Japan

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Matsuyama, , Japan

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Minatoku, , Japan

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Miyazaki, , Japan

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Moriguchi-shi, , Japan

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Morioka, , Japan

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Nagakute-shi, , Japan

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Nagasaki, , Japan

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Nagoya, , Japan

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Nakagami-gun, , Japan

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Nerima-ku, , Japan

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Niigata, , Japan

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Nishinomiya-shi, , Japan

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Noshiro, , Japan

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Obihiro-shi, , Japan

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Ofukeshi, , Japan

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Okayama, , Japan

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Osaka, , Japan

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Osakasayama-shi, , Japan

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Oume-shi, , Japan

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Ōita, , Japan

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Ōmihachiman, , Japan

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Ōta-ku, , Japan

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Ōtsu, , Japan

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Saga, , Japan

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Saitama-shi, , Japan

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Sakaishi, , Japan

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Sano-shi, , Japan

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Sapporo, , Japan

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Sasebo-Shi, , Japan

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Sendai, , Japan

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Shimonoseki-shi, , Japan

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Shimotsuga-gun, , Japan

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Shimotsuke-shi, , Japan

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Shinagawa-ku, , Japan

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Shinjuku-ku, , Japan

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Shirakawa-shi, , Japan

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Shizuoka, , Japan

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Shunan-shi, , Japan

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Sumida-ku, , Japan

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Tagawa-shi, , Japan

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Takamatsu, , Japan

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Takasaki-shi, , Japan

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Toda-shi, , Japan

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Tokorozawa-shi, , Japan

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Tokushima, , Japan

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Tonami-shi, , Japan

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Toyama, , Japan

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Toyoake-shi, , Japan

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Ureshino-shi, , Japan

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Utsunomiya, , Japan

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Wakayama, , Japan

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Yachiyo-shi, , Japan

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Yamagata, , Japan

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Yanagawa-shi, , Japan

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Yatsushiro-shi, , Japan

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Yokkaichi-shi, , Japan

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Yokohama, , Japan

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Yonago-shi, , Japan

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Yoshida-gun, , Japan

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Countries

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Japan

References

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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.

Reference Type DERIVED
PMID: 32869924 (View on PubMed)

Other Identifiers

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GS-US-337-1498

Identifier Type: -

Identifier Source: org_study_id

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