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Ledipasvir/Sofosbuvir in Adults With Chronic HCV Infection Who Are on Dialysis for End Stage Renal Disease (ESRD)

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ClinicalTrials.gov Identifier: NCT03036839
Recruitment Status : Completed
First Posted : January 30, 2017
Last Update Posted : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Description
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Brief Summary:
The primary objectives of this study are to evaluate the safety, efficacy and tolerability of treatment with ledipasvir/sofosbuvir (LDV/SOF) in adults with chronic hepatitis C virus (HCV) infection who are on dialysis for End Stage Renal Disease (ESRD).

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 95 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Ledipasvir/Sofosbuvir in Subjects With Genotype 1, 4, 5 and 6 Chronic HCV Infection Who Are on Dialysis for End Stage Renal Disease
Actual Study Start Date : June 27, 2017
Actual Primary Completion Date : November 22, 2018
Actual Study Completion Date : February 14, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Sofosbuvir

Arms and Interventions
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Arm Intervention/treatment
Experimental: LDV/SOF for 8 weeks
Treatment-naive participants with genotype 1 without cirrhosis will receive LDV/SOF for 8 weeks
 Drug: LDV/SOF
90/400 mg fixed- dose combination (FDC) tablet administered orally once daily
Other Names:
  • Harvoni®
  • GS-5885/GS-7977
Experimental: LDV/SOF for 12 weeks
Treatment-experienced participants with genotype 1 and treatment-naive or treatment-experienced participants with genotype 4, 5, 6 without cirrhosis will receive LDV/SOF for 12 weeks
 Drug: LDV/SOF
90/400 mg fixed- dose combination (FDC) tablet administered orally once daily
Other Names:
  • Harvoni®
  • GS-5885/GS-7977
Experimental: LDV/SOF for 24 weeks
Participants with compensated cirrhosis will receive LDV/SOF for 24 weeks
 Drug: LDV/SOF
90/400 mg fixed- dose combination (FDC) tablet administered orally once daily
Other Names:
  • Harvoni®
  • GS-5885/GS-7977


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) [ Time Frame: Posttreatment Week 12 ]
    SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.

  2. Proportion of Participants Who Permanently Discontinued the Study Drug Due to an Adverse Event [ Time Frame: Up to Week 24 ]

Secondary Outcome Measures :
  1. Proportion of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4) [ Time Frame: Posttreatment Week 4 ]
    SVR4 is defined as HCV RNA < LLOQ 4 weeks after the last dose of study drug.

  2. Proportion of Participants With Sustained Virologic Response 24 Weeks After Discontinuation of Therapy (SVR24) [ Time Frame: Posttreatment Week 24 ]
    SVR24 is defined as HCV RNA < LLOQ 24 weeks after the last dose of study drug.

  3. Proportion of participants with HCV RNA < LLOQ on treatment [ Time Frame: Up to Week 24 ]
  4. Change From Baseline in HCV RNA [ Time Frame: Up to Week 24 ]
  5. Proportion of Participants With Virologic Failure [ Time Frame: Up to Posttreatment Week 24 ]

    Virologic failure is 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.

  6. Proportion of Participants Who Develop Resistance to LDV and SOF During Treatment [ Time Frame: Up to Week 24 ]
  7. Proportion of Participants Who Develop Resistance to LDV and SOF After Discontinuation of Therapy [ Time Frame: Up to Posttreatment Week 24 ]
  8. Pharmacokinetic (PK) Parameter: AUCtau of LDV [ Time Frame: Predose and up to 12 hours Postdose ]
  9. Pharmacokinetic (PK) Parameter: AUCtau of SOF and its metabolites [ Time Frame: Predose and up to 12 hours Postdose ]
  10. Pharmacokinetic (PK) Parameter: Tmax of LDV [ Time Frame: Predose and up to 12 hours Postdose ]
  11. Pharmacokinetic (PK) Parameter: Tmax of SOF and its metabolites [ Time Frame: Predose and up to 12 hours Postdose ]

Eligibility Criteria
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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

Key Inclusion Criteria:

  • Chronic HCV infected genotype 1, 4, 5, or 6 male and non-pregnant/ non-lactating females aged 18 years or older who are on dialysis for ESRD, including adults with HIV co-infection if they are suppressed on a stable, protocol-approved antiretroviral (ARV) regimens for ≥8 weeks prior to screening.

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Contacts and Locations
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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): NCT03036839


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, New York
James J. Peters VA Hospital
Bronx, New York, United States, 10468
United States, Texas
The Liver Institute at Methodist Dallas Medical Center
Dallas, Texas, United States, 75203
Texas Liver Institute/American Research Corporation
San Antonio, Texas, United States, 78215
United States, Washington
University of Washington/Harborview Medical Center
Seattle, Washington, United States, 98104
Belgium
CUB Hopital Erasme
Brussels, Belgium, 1070
Cliniques Universitaires UCL Saint-Luc
Brussels, Belgium, 1200
Germany
Klinikum der Johann Wolfgang Goethe-Universität
Frankfurt, Germany, 60590
Universitatsklinikum Hamburg-Eppendorf (UKE), Zentrum fur Innere Medizin - Studienambulanz Hepatol.
Hamburg, Germany, 20246
Ifi Studien und Projekt GmbH an der Asklepios Klinik St. Georg
Hamburg, Germany, 20251
Universitätsklinikum Leipzig
Leipzig, Germany, 04103
Italy
IRCCS Ospedale Casa Sollievo Della Sofferrenza
San Giovanni Rotondo, Foggia, Italy, 71013
Ospedale Santa Maria Annunziata
Antella, Italy, 50011
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, Italy, 20122
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Torino, Italy, 10126
Taiwan
Changhua Christian Hospital
Changhua, Taiwan, 500
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, Taiwan, 80756
Chang Gung Medical Foundation, Kaohsiung Chang Gung Memorial Hospital
Kaohsiung, Taiwan, 83301
China Medical University Hospital
Taichung, Taiwan, 40447
National Taiwan University Hospital
Taipei, Taiwan, 10002
Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences
More Information
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT03036839     History of Changes
Other Study ID Numbers: GS-US-337-4063
2016-003489-25 ( EudraCT Number )
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019
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 https://www.gilead.com/about/ethics-and-code-of-conduct/policies.
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: https://www.gilead.com/about/ethics-and-code-of-conduct/policies

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Kidney Diseases
Kidney Failure, Chronic
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis
 Liver Diseases
Digestive System Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Sofosbuvir
Ledipasvir
Ledipasvir, sofosbuvir drug combination
Antiviral Agents
Anti-Infective Agents