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Ledipasvir/Sofosbuvir Fixed-Dose Combination in Adults With Nosocomial Genotype 1 HCV Infection

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ClinicalTrials.gov Identifier: NCT01924949
Recruitment Status : Completed
First Posted : August 19, 2013
Results First Posted : May 29, 2015
Last Update Posted : November 19, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
This study is to evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in adults with nosocomial genotype 1 hepatitis C virus (HCV) infection.

Condition or disease Intervention/treatment Phase
Hepatitis C Drug: LDV/SOF Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Study of Sofosbuvir/Ledipasvir Fixed-Dose Combination for 12 Weeks in Subjects With Nosocomial Genotype 1 HCV Infection
Study Start Date : July 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Sofosbuvir

Arm Intervention/treatment
Experimental: LDV/SOF
Participants will receive LDV/SOF FDC for 12 weeks.
Drug: LDV/SOF
Ledipasvir (LDV)/sofosbuvir (SOF) 90/400 mg FDC tablet administered orally once daily
Other Names:
  • Harvoni®
  • GS-5885/GS-7977




Primary Outcome Measures :
  1. Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12) [ Time Frame: Posttreatment Week 12 ]
    SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.

  2. Percentage of Participants Permanently Discontinuing Study Drug Due to an Adverse Event [ Time Frame: Up to 12 weeks ]

Secondary Outcome Measures :
  1. Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) [ Time Frame: Posttreatment Weeks 4 and 24 ]
    SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.

  2. Percentage of Participants With HCV RNA < LLOQ on Treatment [ Time Frame: Up to 12 weeks ]
  3. HCV RNA Change From Baseline [ Time Frame: Baseline; Weeks 1, 4, and 8 ]
  4. Percentage of Participants Experiencing Virologic Failure [ Time Frame: Baseline to posttreatment Week 24 ]

    Virologic failure was defined as

    On-treatment virologic failure:

    • Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
    • Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
    • Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)

    Virologic relapse:

    • Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.



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

Inclusion Criteria:

  • Body mass index (BMI) greater than or equal to 18 kg/m^2.
  • HCV RNA greater than or equal to 1000 IU/mL at screening.
  • Documented acquisition of nosocomial genotype 1 HCV infection within 36 months from the screening visit.
  • Screening laboratory values within predefined thresholds.
  • Use of two effective contraception methods if female of childbearing potential or sexually active male.
  • Healthy according to medical history and physical examination with the exception of HCV diagnosis.

Exclusion Criteria:

  • Unstable cardiac disease including subjects with active angina pectoris and/or hospitalization for a cardiac condition within 24 weeks prior to screening.
  • Prior exposure to an HCV NS5a inhibitor.
  • Pregnant or nursing female.
  • Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).
  • History of solid organ transplantation.
  • Current or prior history of clinical hepatic decompensation.
  • History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment, or compliance with the protocol.
  • Known hypersensitivity to LDV, SOF, or formulation excipients.

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): NCT01924949


Locations
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United States, Massachusetts
Boston, Massachusetts, United States
Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Luisa Stamm, MD, PhD Gilead Sciences

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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01924949     History of Changes
Other Study ID Numbers: GS-US-337-0125
First Posted: August 19, 2013    Key Record Dates
Results First Posted: May 29, 2015
Last Update Posted: November 19, 2018
Last Verified: May 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: 18 months after study completion
Access Criteria: A secured external environment with username, password, and RSA code.
URL: http://www.gilead.com/research/disclosure-and-transparency
Keywords provided by Gilead Sciences:
7977
5885
GS-7977
GS-5885
SOF
LDV
Sofosbuvir
Ledipasvir
FDC
Additional relevant MeSH terms:
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Virus Diseases
RNA Virus Infections
Ledipasvir
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Flaviviridae Infections
Sofosbuvir
Antiviral Agents
Anti-Infective Agents