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

NCT ID: NCT03036839

Last Updated: 2020-03-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-27

Study Completion Date

2019-02-14

Brief Summary

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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 HCV infection who are on dialysis for ESRD.

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Detailed Description

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Conditions

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Hepatitis C Virus Infection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LDV/SOF for 8 weeks

Treatment-naive participants with genotype 1 without cirrhosis will receive LDV/SOF for 8 weeks

Group Type EXPERIMENTAL

LDV/SOF

Intervention Type DRUG

90/400 mg fixed- dose combination (FDC) tablet administered orally once daily

LDV/SOF for 12 weeks

Treatment-experienced participants with genotype 1 and treatment-naive or treatment-experienced participants with genotype 2 (Taiwan only), 4, 5 and 6 without cirrhosis will receive LDV/SOF for 12 weeks

Group Type EXPERIMENTAL

LDV/SOF

Intervention Type DRUG

90/400 mg fixed- dose combination (FDC) tablet administered orally once daily

LDV/SOF for 24 weeks

Participants with compensated cirrhosis will receive LDV/SOF for 24 weeks

Group Type EXPERIMENTAL

LDV/SOF

Intervention Type DRUG

90/400 mg fixed- dose combination (FDC) tablet administered orally once daily

Interventions

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LDV/SOF

90/400 mg fixed- dose combination (FDC) tablet administered orally once daily

Intervention Type DRUG

Other Intervention Names

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Harvoni® GS-5885/GS-7977

Eligibility Criteria

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Inclusion Criteria

* Chronic HCV infected genotype 1, 2 (Taiwan only), 4, 5, or 6 male and nonpregnant/ nonlactating females aged 18 years or older who are on dialysis for ESRD, including adults with HIV coinfection if they are suppressed on a stable, protocol-approved antiretroviral (ARV) regimens for ≥8 weeks prior to screening.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gilead Sciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gilead Study Director

Role: STUDY_DIRECTOR

Gilead Sciences

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Henry Ford Health System

Detroit, Michigan, United States

Site Status

James J. Peters VA Hospital

The Bronx, New York, United States

Site Status

The Liver Institute at Methodist Dallas Medical Center

Dallas, Texas, United States

Site Status

Texas Liver Institute/American Research Corporation

San Antonio, Texas, United States

Site Status

University of Washington/Harborview Medical Center

Seattle, Washington, United States

Site Status

CUB Hopital Erasme

Brussels, , Belgium

Site Status

Cliniques Universitaires UCL Saint-Luc

Brussels, , Belgium

Site Status

Klinikum der Johann Wolfgang Goethe-Universität

Frankfurt, , Germany

Site Status

Universitatsklinikum Hamburg-Eppendorf (UKE), Zentrum fur Innere Medizin - Studienambulanz Hepatol.

Hamburg, , Germany

Site Status

Ifi Studien und Projekt GmbH an der Asklepios Klinik St. Georg

Hamburg, , Germany

Site Status

Universitätsklinikum Leipzig

Leipzig, , Germany

Site Status

IRCCS Ospedale Casa Sollievo Della Sofferrenza

San Giovanni Rotondo, Foggia, Italy

Site Status

Ospedale Santa Maria Annunziata

Antella, , Italy

Site Status

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Milan, , Italy

Site Status

Azienda Ospedaliera Città della Salute e della Scienza di Torino

Torino, , Italy

Site Status

Changhua Christian Hospital

Changhua, , Taiwan

Site Status

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, , Taiwan

Site Status

Chang Gung Medical Foundation, Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

Site Status

China Medical University Hospital

Taichung, , Taiwan

Site Status

National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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United States Belgium Germany Italy Taiwan

References

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Chuang W-L, Hu T-H, Buggisch P, et al. Ledipasvir/sofosbuvir for 8, 12, or 24 weeks is safe and effective in patients undergoing dialysis. J Hepatol 2019;70 (Suppl 1S):e225.

Reference Type BACKGROUND

Chuang WL, Hu TH, Buggisch P, Moreno C, Su WW, Biancone L, Camargo M, Hyland R, Lu S, Kirby BJ, Dvory-Sobol H, Osinusi A, Gaggar A, Peng CY, Liu CH, Sise ME, Mangia A. Ledipasvir/Sofosbuvir for 8, 12, or 24 Weeks in Hepatitis C Patients Undergoing Dialysis for End-Stage Renal Disease. Am J Gastroenterol. 2021 Sep 1;116(9):1924-1928. doi: 10.14309/ajg.0000000000001281.

Reference Type DERIVED
PMID: 34465694 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2016-003489-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GS-US-337-4063

Identifier Type: -

Identifier Source: org_study_id

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