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

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ClinicalTrials.gov Identifier: NCT02537379
Recruitment Status : Completed
First Posted : September 1, 2015
Last Update Posted : June 27, 2017
Sponsor:
Collaborator:
Chugai Pharmaceutical
Information provided by (Responsible Party):
Gilead Sciences

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.

Condition or disease Intervention/treatment
Hepatitis C Virus Infection Drug: SOF Drug: COPE

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Study Type : Observational
Actual Enrollment : 552 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: A Prospective Observational Post-Marketing Study of Sovaldi® Plus Copegus® in Japanese Patients With Chronic Genotype 2 Hepatitis C Virus Infection
Actual Study Start Date : September 15, 2015
Actual Primary Completion Date : June 5, 2017
Actual Study Completion Date : June 5, 2017

Resource links provided by the National Library of Medicine


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

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

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): NCT02537379


Locations
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Japan
Amagasaki-shi, Japan
Asahi-shi, Japan
Asahikawa-shi, Japan
Beppu-shi, Japan
Chichibu-shi, Japan
Fujioka-shi, Japan
Fukui-shi, Japan
Hamamatsu-shi, Japan
Iizuka-shi, Japan
Inzai-shi, Japan
Ishinomaki-shi, Japan
Iwaki-shi, Japan
Izunokuni-shi, Japan
Kahoku-gun, Japan
Kanazawa-shi, Japan
Kirishima-shi, Japan
Kisarazu-shi, Japan
Kitamoto-shi, Japan
Kobe-shi, Japan
Koshigaya-shi, Japan
Kure-shi, Japan
Moriguchi-shi, Japan
Nagakute-shi, Japan
Nagaoka-shi, Japan
Nagasaki-shi, Japan
Nagoya-shi, Japan
Nakagami-gun, Japan
Nanto-shi, Japan
Nishinomiya-shi, Japan
Ogi-shi, Japan
Okayama-shi, Japan
Ome-shi, Japan
Osaka-shi, Japan
Ota-ku, Japan
Sapporo-shi, Japan
Sasebo-Shi, Japan
Sendai-shi, Japan
Shinagawa-ku, Japan
Shinjuku-ku, Japan
Tokorozawa-shi, Japan
Tokushima-shi, Japan
Wakayama-shi, Japan
Yachiyo-shi, Japan
Yokohama-shi, Japan
Yufu-shi, Japan
Sponsors and Collaborators
Gilead Sciences
Chugai Pharmaceutical
Investigators
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Study Director: Gilead Study Director Gilead Sciences
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02537379    
Other Study ID Numbers: GS-US-334-1444 / COPE1501
First Posted: September 1, 2015    Key Record Dates
Last Update Posted: June 27, 2017
Last Verified: June 2017
Keywords provided by Gilead Sciences:
Hepatitis C virus
observational
post-marketing
sofosbuvir
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Hepatitis A
Hepatitis C
Hepatitis
Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents