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Use-Results Surveillance Study of Sovaldi® Plus Rebetol® in Japanese Patients With Chronic Genotype 2 Hepatitis C Virus Infection

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ClinicalTrials.gov Identifier: NCT02562742
Recruitment Status : Completed
First Posted : September 29, 2015
Last Update Posted : August 1, 2017
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Gilead Sciences

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.

Condition or disease Intervention/treatment
Hepatitis C Drug: SOF Drug: REB

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Study Type : Observational
Actual Enrollment : 554 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: A Prospective Observational Post-Marketing Study of Sovaldi® Plus Rebetol® in Japanese Patients With Chronic Genotype 2 Hepatitis C Virus Infection
Actual Study Start Date : November 12, 2015
Actual Primary Completion Date : June 12, 2017
Actual Study Completion Date : June 12, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
SOF+REB
Adult patients with 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.
Drug: SOF
SOF 400 mg tablets administered orally once daily
Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977

Drug: REB
REB capsules administered orally in a divided daily weight-based dose according to the package insert for the approved Rebetol® labeling in Japan (< 60 kg = 600 mg , > 60 kg to ≤ 80 kg = 800 mg, and > 80 kg = 1000 mg)
Other Names:
  • Rebetol®
  • Ribavirin




Primary Outcome Measures :
  1. Incidence of adverse drug reaction (ADR) under real world settings [ Time Frame: Up to 16 weeks ]

Secondary Outcome Measures :
  1. 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.

  2. Proportion of participants with HCV NS5B resistance associated variants among patients who do not achieve SVR at 12 weeks [ Time Frame: Approximately 12 weeks after treatment completion or discontinuation ]

Biospecimen Retention:   Samples With DNA
Whole blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02562742


Locations
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Japan
Ageo-shi, Japan
Bunkyo-ku, Japan
Chuo-shi, Japan
Fujioka-shi, Japan
Fukui-shi, Japan
Fukuoka-shi, Japan
Hakodate-shi, Japan
Handa-shi, Japan
Ichihara-shi, Japan
Inashiki-gun, Japan
Iruma-gun, Japan
Kamogawa-shi, Japan
Karatsu-shi, Japan
Kashiwa-shi, Japan
Katsushika-ku, Japan
Kawagoe-shi, Japan
Kawasaki-shi, Japan
Kitamoto-shi, Japan
Kobe-shi, Japan
Kodaira-shi, Japan
Koto-ku, Japan
Kurume-shi, Japan
Kyoto-shi, Japan
Matsue-shi, Japan
Matsuyama-shi, Japan
Minato-ku, Japan
Miyazaki-shi, Japan
Morioka-shi, Japan
Nagoya-shi, Japan
Osaka-shi, Japan
Osakasayama-shi, Japan
Saitama-shi, Japan
Sakai-shi, Japan
Sapporo-shi, Japan
Shibuya-ku, Japan
Shimotsuke-shi, Japan
Shinjuku-ku, Japan
Sumida-ku, Japan
Tagawa-shi, Japan
Tondabayashi-shi, Japan
Toyama-shi, Japan
Toyoake-shi, Japan
Utsunomiya-shi, Japan
Yanagawa-shi, Japan
Yokohama-shi, Japan
Sponsors and Collaborators
Gilead Sciences
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Gilead Study Director Gilead Sciences

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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02562742     History of Changes
Other Study ID Numbers: GS-US-334-1879
First Posted: September 29, 2015    Key Record Dates
Last Update Posted: August 1, 2017
Last Verified: July 2017

Keywords provided by Gilead Sciences:
Hepatitis C virus
observational
post-marketing
sofosbuvir
Infection

Additional relevant MeSH terms:
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Infection
Hepatitis
Hepatitis A
Hepatitis C
Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Sofosbuvir
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents