NCT03036839

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 HCV infection who are on dialysis for ESRD.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2017

Geographic Reach
5 countries

21 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 30, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

June 27, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2019

Completed
10 months until next milestone

Results Posted

Study results publicly available

December 9, 2019

Completed
Last Updated

March 2, 2020

Status Verified

November 1, 2019

Enrollment Period

1.4 years

First QC Date

January 27, 2017

Results QC Date

November 15, 2019

Last Update Submit

February 18, 2020

Conditions

Hepatitis C Virus Infection

Outcome Measures

Primary Outcomes (2)

  • Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)

    SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. The exact 95% confidence interval (CI) for the percentage within treatment group was based on the Clopper-Pearson method.

    Posttreatment Week 12

  • Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event

    First dose date up to Week 24

Secondary Outcomes (13)

  • Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)

    Posttreatment Week 4

  • Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)

    Posttreatment Week 24

  • Percentage of Participants With HCV RNA < LLOQ on Treatment

    Weeks 2, 4, 6, 8, 12, 16, 20, 24

  • HCV RNA

    Weeks 2, 4, 6, 8, 12, 16, 20, 24

  • Change From Baseline in HCV RNA

    Weeks 2, 4, 6, 8, 12, 16, 20, 24

  • +8 more secondary outcomes

Study Arms (3)

LDV/SOF for 8 weeks

EXPERIMENTAL

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

Drug: LDV/SOF

LDV/SOF for 12 weeks

EXPERIMENTAL

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

Drug: LDV/SOF

LDV/SOF for 24 weeks

EXPERIMENTAL

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

Drug: LDV/SOF

Interventions

LDV/SOFDRUG

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

Also known as: Harvoni®, GS-5885/GS-7977
LDV/SOF for 12 weeksLDV/SOF for 24 weeksLDV/SOF for 8 weeks

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

James J. Peters VA Hospital

The Bronx, New York, 10468, United States

Location

The Liver Institute at Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

Texas Liver Institute/American Research Corporation

San Antonio, Texas, 78215, United States

Location

University of Washington/Harborview Medical Center

Seattle, Washington, 98104, United States

Location

CUB Hopital Erasme

Brussels, 1070, Belgium

Location

Cliniques Universitaires UCL Saint-Luc

Brussels, 1200, Belgium

Location

Klinikum der Johann Wolfgang Goethe-Universität

Frankfurt, 60590, Germany

Location

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

Hamburg, 20246, Germany

Location

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

Hamburg, 20251, Germany

Location

Universitätsklinikum Leipzig

Leipzig, 04103, Germany

Location

IRCCS Ospedale Casa Sollievo Della Sofferrenza

San Giovanni Rotondo, Foggia, 71013, Italy

Location

Ospedale Santa Maria Annunziata

Antella, 50011, Italy

Location

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

Azienda Ospedaliera Città della Salute e della Scienza di Torino

Torino, 10126, Italy

Location

Changhua Christian Hospital

Changhua, 500, Taiwan

Location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 80756, Taiwan

Location

Chang Gung Medical Foundation, Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 83301, Taiwan

Location

China Medical University Hospital

Taichung, 40447, Taiwan

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Related Publications (2)

  • 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.

    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.

    PMID: 34465694DERIVED

MeSH Terms

Conditions

Hepatitis C

Interventions

ledipasvir, sofosbuvir drug combination

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Results Point of Contact

Title
Gilead Clinical Study Information Center
Organization
Gilead Sciences
GileadClinicalTrials@gilead.com
1-833-445-3230 (GILEAD-0)

Study Officials

  • Gilead Study Director

    Gilead Sciences

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2017

First Posted

January 30, 2017

Study Start

June 27, 2017

Primary Completion

November 22, 2018

Study Completion

February 14, 2019

Last Updated

March 2, 2020

Results First Posted

December 9, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will share

Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
18 months after study completion
Access Criteria
A secured external environment with username, password, and RSA code.
More information

Locations

BE(2)TW(5)DE(4)IT(4)US(6)