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

February 4, 2019 updated by: Gilead Sciences

A Prospective Observational Post-Marketing Study of Harvoni in Japanese Patients With Genotype 1 Chronic Hepatitis C Infection

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

3294

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Ageo-shi, Japan
      • Akita-shi, Japan
      • Amagasaki-shi, Japan
      • Aomori-shi, Japan
      • Arao-shi, Japan
      • Asahi-shi, Japan
      • Asahikawa-shi, Japan
      • Asakura-shi, Japan
      • Bunkyo-ku, Japan
      • Chiba-shi, Japan
      • Chichibu-shi, Japan
      • Chuo-shi, Japan
      • Fujioka-shi, Japan
      • Fukui-shi, Japan
      • Fukuoka-shi, Japan
      • Gifu-shi, Japan
      • Hakodate-shi, Japan
      • Hamamatsu-shi, Japan
      • Handa-shi, Japan
      • Hashima-shi, Japan
      • Hatsukaichi-shi, Japan
      • Higashiibaraki-gun, Japan
      • Hirosaki-shi, Japan
      • Hiroshima-shi, Japan
      • Hitachi-shi, Japan
      • Hukui-shi, Japan
      • Ichikawa-shi, Japan
      • Iizuka-shi, Japan
      • Ikeda-shi, Japan
      • Inashiki-gun, Japan
      • Inzai-shi, Japan
      • Iruma-gun, Japan
      • Ise-shi, Japan
      • Iwaki-shi, Japan
      • Izumo-shi, Japan
      • Izunokuni-shi, Japan
      • Kagoshima-shi, Japan
      • Kamogawa-shi, Japan
      • Kanazawa-shi, Japan
      • Karatsu-shi, Japan
      • Kashihara-shi, Japan
      • Kashiwa-shi, Japan
      • Kasukabe-shi, Japan
      • Kawagoe-shi, Japan
      • Kawaguchi-shi, Japan
      • Kawasaki-shi, Japan
      • Kirishima-shi, Japan
      • Kitakyushu-shi, Japan
      • Kitamoto-shi, Japan
      • Kobe-shi, Japan
      • Kodaira-shi, Japan
      • Kofu-shi, Japan
      • Komae-shi, Japan
      • Komaki-shi, Japan
      • Koriyama-shi, Japan
      • Koshigaya-shi, Japan
      • Koto-ku, Japan
      • Kuga-gun, Japan
      • Kuki-shi, Japan
      • Kumamoto-shi, Japan
      • Kurashiki-shi, Japan
      • Kure-shi, Japan
      • Kurume-shi, Japan
      • Kyoto-shi, Japan
      • Maebashi-shi, Japan
      • Matsumoto-shi, Japan
      • Matsuyama-shi, Japan
      • Minato-ku, Japan
      • Miyazaki-shi, Japan
      • Moriguchi-shi, Japan
      • Morioka-shi, Japan
      • Nagakute-shi, Japan
      • Nagasaki-shi, Japan
      • Nagoya-shi, Japan
      • Nakagami-gun, Japan
      • Nerima-ku, Japan
      • Niigata-shi, Japan
      • Nishinomiya-shi, Japan
      • Noshiro-shi, Japan
      • Obihiro-shi, Japan
      • Ogi-shi, Japan
      • Oita-shi, Japan
      • Okayama-shi, Japan
      • Omihachiman-shi, Japan
      • Osaka-shi, Japan
      • Osakasayama-shi, Japan
      • Ota-ku, Japan
      • Otsu-shi, Japan
      • Oume-shi, Japan
      • Saga-shi, Japan
      • Saitama-shi, Japan
      • Sakai-shi, Japan
      • Sano-shi, Japan
      • Sapporo-shi, Japan
      • Sasebo-Shi, Japan
      • Sendai-shi, Japan
      • Shimonoseki-shi, Japan
      • Shimotsuga-gun, Japan
      • Shimotsuke-shi, Japan
      • Shinagawa-ku, Japan
      • Shinjuku-ku, Japan
      • Shirakawa-shi, Japan
      • Shizuoka-shi, Japan
      • Shunan-shi, Japan
      • Sumida-ku, Japan
      • Tagawa-shi, Japan
      • Takamatsu-shi, Japan
      • Takasaki-shi, Japan
      • Toda-shi, Japan
      • Tokorozawa-shi, Japan
      • Tokushima-shi, Japan
      • Tonami-shi, Japan
      • Toyama-shi, Japan
      • Toyoake-shi, Japan
      • Ureshino-shi, Japan
      • Utsunomiya-shi, Japan
      • Wakayama-shi, Japan
      • Yachiyo-shi, Japan
      • Yamagata-shi, Japan
      • Yanagawa-shi, Japan
      • Yatsushiro-shi, Japan
      • Yokkaichi-shi, Japan
      • Yokohama-shi, Japan
      • Yonago-shi, Japan
      • Yoshida-gun, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Drug: Harvoni
Harvoni (90/400 mg) FDC tablet administered orally once daily
Other Names:
  • GS-5885/GS-7977
  • LDV/SOF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse drug reaction (ADR) under real world settings
Time Frame: Up to 16 weeks
Up to 16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants with sustained virologic response (SVR) 12 and 24 weeks after discontinuation of therapy (SVR12 and SVR24)
Time Frame: Posttreatment Weeks 12 and 24
SVR12 and SVR24 are defined as HCV RNA < the lower limit of quantification (LLOQ) 12 and 24 weeks following the last dose of study drug, respectively.
Posttreatment Weeks 12 and 24
Proportion of participants with HCV NS5A and NS5B resistance associated variants among patients who do not achieve SVR at 12 weeks
Time Frame: Approximately 12 weeks after treatment completion or discontinuation
Approximately 12 weeks after treatment completion or discontinuation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2015

Primary Completion (Actual)

November 1, 2017

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

October 28, 2015

First Submitted That Met QC Criteria

October 28, 2015

First Posted (Estimate)

October 29, 2015

Study Record Updates

Last Update Posted (Actual)

February 6, 2019

Last Update Submitted That Met QC Criteria

February 4, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-US-337-1498

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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