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Trial record 52 of 115 for:    "Viral Infectious Disease" | "Ledipasvir"

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

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ClinicalTrials.gov Identifier: NCT02591277
Recruitment Status : Completed
First Posted : October 29, 2015
Last Update Posted : February 6, 2019
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

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.

Condition or disease Intervention/treatment
Hepatitis C Drug: Harvoni

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Study Type : Observational
Actual Enrollment : 3294 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: A Prospective Observational Post-Marketing Study of Harvoni in Japanese Patients With Genotype 1 Chronic Hepatitis C Infection
Actual Study Start Date : November 30, 2015
Actual Primary Completion Date : November 1, 2017
Actual Study Completion Date : November 1, 2017

Resource links provided by the National Library of Medicine


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:
  • LDV/SOF
  • GS-5885/GS-7977




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 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 ]

Biospecimen Retention:   Samples With DNA
Whole blood


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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 chronic genotype 1 HCV infection with or without compensated cirrhosis who take Harvoni as part of routine clinical care at a participating clinic/hospital.
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.


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): NCT02591277


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Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences

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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02591277     History of Changes
Other Study ID Numbers: GS-US-337-1498
First Posted: October 29, 2015    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gilead Sciences:
Hepatitis C virus
observational
post-marketing
ledipasvir/sofosbuvir
Japan
Additional relevant MeSH terms:
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Virus Diseases
RNA Virus Infections
Ledipasvir, sofosbuvir drug combination
Hepatitis A
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Flaviviridae Infections
Antiviral Agents
Anti-Infective Agents