Ledipasvir/Sofosbuvir in Adults With Chronic Hepatitis C Virus (HCV) Infection Who Are on Dialysis for End Stage Renal Disease - Clinical Trial for Hepatitis C Virus Infection | NCT03036839

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

LDV/SOF

About this trial

This is an interventional treatment trial for Hepatitis C Virus Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key 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.

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

Sites / Locations

Massachusetts General Hospital
Henry Ford Health System
James J. Peters VA Hospital
The Liver Institute at Methodist Dallas Medical Center
Texas Liver Institute/American Research Corporation
University of Washington/Harborview Medical Center
CUB Hopital Erasme
Cliniques Universitaires UCL Saint-Luc
Klinikum der Johann Wolfgang Goethe-Universität
Universitatsklinikum Hamburg-Eppendorf (UKE), Zentrum fur Innere Medizin - Studienambulanz Hepatol.
Ifi Studien und Projekt GmbH an der Asklepios Klinik St. Georg
Universitätsklinikum Leipzig
IRCCS Ospedale Casa Sollievo Della Sofferrenza
Ospedale Santa Maria Annunziata
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Changhua Christian Hospital
Kaohsiung Medical University Chung-Ho Memorial Hospital
Chang Gung Medical Foundation, Kaohsiung Chang Gung Memorial Hospital
China Medical University Hospital
National Taiwan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

LDV/SOF for 8 weeks

LDV/SOF for 12 weeks

LDV/SOF for 24 weeks

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

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

Secondary Outcome Measures

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

SVR4 was defined as HCV RNA < LLOQ (ie, 15 IU/mL) at 4 weeks after stopping study treatment. The exact 95% CI for the percentage within treatment group was based on the Clopper-Pearson method.

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

SVR24 was defined as HCV RNA < LLOQ (ie, 15 IU/mL) at 24 weeks after stopping study treatment. The exact 95% CI for the percentage within treatment group was based on the Clopper-Pearson method.

Percentage of Participants With HCV RNA < LLOQ on Treatment

The total number of participants with HCV RNA < LLOQ was the sum of the number of participants with HCV RNA "< LLOQ detected" plus the number of participants with HCV RNA "< LLOQ target not detected (TND)". LLOQ was 15 IU/mL. The exact 95% CI for the percentage within treatment group was based on the Clopper-Pearson method.

HCV RNA

Change From Baseline in HCV RNA

Percentage of Participants With Virologic Failure

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.

Percentage of Participants Who Developed Resistance to LDV and SOF

Pharmacokinetics (PK) Parameter: AUCtau of LDV

AUCtau is defined as the population PK derived area under the concentration versus time curve of the drug over the dosing interval.

PK Parameter: AUCtau of SOF

AUCtau is defined as the population PK derived area under the concentration versus time curve of the drug over the dosing interval.

PK Parameter: AUCtau of GS-331007 (Metabolite of SOF)

AUCtau is defined as the population PK derived area under the concentration versus time curve of the drug over the dosing interval.

PK Parameter: Cmax of LDV

Cmax is defined as the population PK derived maximum concentration of the drug.

PK Parameter: Cmax of SOF

Cmax is defined as the population PK derived maximum concentration of the drug.

PK Parameter: Cmax of GS-331007 (Metabolite of SOF)

Cmax is defined as the population PK derived maximum concentration of the drug.

Full Information

NCT ID

NCT03036839

First Posted

January 27, 2017

Last Updated

February 18, 2020

Sponsor

Gilead Sciences

1. Study Identification

Unique Protocol Identification Number

NCT03036839

Brief Title

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

Acronym

ESRD

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Completed

Study Start Date

June 27, 2017 (Actual)

Primary Completion Date

November 22, 2018 (Actual)

Study Completion Date

February 14, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Gilead Sciences

4. Oversight

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

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis C Virus Infection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

95 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LDV/SOF for 8 weeks

Arm Type

Experimental

Arm Description

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

Arm Title

LDV/SOF for 12 weeks

Arm Type

Experimental

Arm Description

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

Arm Title

LDV/SOF for 24 weeks

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

LDV/SOF

Other Intervention Name(s)

Harvoni®, GS-5885/GS-7977

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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.

Time Frame

Posttreatment Week 12

Title

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

Time Frame

First dose date up to Week 24

Secondary Outcome Measure Information:

Title

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

Description

SVR4 was defined as HCV RNA < LLOQ (ie, 15 IU/mL) at 4 weeks after stopping study treatment. The exact 95% CI for the percentage within treatment group was based on the Clopper-Pearson method.

Time Frame

Posttreatment Week 4

Title

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

Description

SVR24 was defined as HCV RNA < LLOQ (ie, 15 IU/mL) at 24 weeks after stopping study treatment. The exact 95% CI for the percentage within treatment group was based on the Clopper-Pearson method.

Time Frame

Posttreatment Week 24

Title

Percentage of Participants With HCV RNA < LLOQ on Treatment

Description

The total number of participants with HCV RNA < LLOQ was the sum of the number of participants with HCV RNA "< LLOQ detected" plus the number of participants with HCV RNA "< LLOQ target not detected (TND)". LLOQ was 15 IU/mL. The exact 95% CI for the percentage within treatment group was based on the Clopper-Pearson method.

Time Frame

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

Title

HCV RNA

Time Frame

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

Title

Change From Baseline in HCV RNA

Time Frame

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

Title

Percentage of Participants With Virologic Failure

Description

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.

Time Frame

Baseline up to Posttreatment Week 24

Title

Percentage of Participants Who Developed Resistance to LDV and SOF

Time Frame

Baseline up to Posttreatment Week 24

Title

Pharmacokinetics (PK) Parameter: AUCtau of LDV

Description

AUCtau is defined as the population PK derived area under the concentration versus time curve of the drug over the dosing interval.

Time Frame