Sofosbuvir/Velpatasvir in Adults With Chronic Hepatitis C Virus Infection Who Are on Dialysis for End Stage Renal Disease - Clinical Trial for Chronic Hepatitis C | NCT03036852

Back to results

Primary Purpose

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

SOF/VEL

About this trial

This is an interventional treatment trial for Chronic Hepatitis C

Eligibility Criteria

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

Key Inclusion Criteria:

Chronic HCV infected, 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) regimen for ≥8 weeks prior to screening.

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

Sites / Locations

Royal Adelaide Hospital
Kaye Edmonton Clinic
Gordon and Leslie Diamond Health Care Center, Vancouver General Hospital, UBC Division of Gastroenterology
William Osler Health System- Brampton Civic Hospital
Hamilton Health Sciences - McMaster University Medical Centre Site
Ottawa Hospital Research Institute
Centre de Recherche du Centre Hospitalier de l'Universite de Montreal (CRCHUM)
Shaare Zedek Medical Center
The Chaim Sheba Medical Centre
Tel Aviv Sourasky Medical Center
Auckland City Hospital
Hospital Universitario Fundación Alcorcón
Hospital Universitari Vall d'Hebron
Hospital Universitario Puerta de Hierro - Majadahonda
Hospital Universitario Virgen del Rocío
Gartnavel General Hospital
Barts Health NHS Trust
King's College Hospital
Chelsea and Westminster Hospital
Imperial College Healthcare NHS Trust
Nottingham University Hospitals NHS Trust
Derriford Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SOF/VEL

Arm Description

SOF/VEL for 12 weeks

Outcomes

Primary Outcome Measures

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

SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) 12 weeks after stopping the study treatment.

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

Secondary Outcome Measures

Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4)

SVR4 was defined as HCV RNA < LLOQ 4 weeks after stopping study treatment.

Percentage of Participants With Sustained Virologic Response 24 Weeks After Discontinuation of Therapy (SVR24)

SVR24 was defined as HCV RNA < LLOQ 24 weeks after stopping study treatment.

Change From Baseline in HCV RNA

Percentage of Participants With HCV RNA < LLOQ on Treatment

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

Number of Participants Who Develop Viral Resistance (as Assessed by Presence of HCV NS5A and NS5B Genes) to SOF and VEL During Treatment and After Discontinuation of Treatment

Baseline deep sequencing of the HCV NS5A and NS5B genes was performed for all participants. For all participants with virologic failure, deep sequencing was performed at the first time point after virologic failure if the plasma or serum sample was available and HCV RNA was > 1000 IU/mL.

Pharmacokinetic (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: AUCtau of VEL

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

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.

PK Parameter: Cmax of VEL

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

PK Parameter: Ctau of VEL

Ctau is defined as the population PK derived concentration of the drug at the end of a 24 hour dosing interval. The 24 hour Ctau is estimated based on the combination of sparse PK samples collected at random times across the dosing interval as well as intensive PK samples collected for up to 12 hours post-dose.

Full Information

NCT ID

NCT03036852

First Posted

January 27, 2017

Last Updated

February 18, 2020

Sponsor

Gilead Sciences

1. Study Identification

Unique Protocol Identification Number

NCT03036852

Brief Title

Sofosbuvir/Velpatasvir in Adults With Chronic Hepatitis C Virus Infection Who Are on Dialysis for End Stage Renal Disease

Acronym

SOF/VEL ESRD

Official Title

A Phase 2, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir for 12 Weeks in Subjects With 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

March 22, 2017 (Actual)

Primary Completion Date

August 13, 2018 (Actual)

Study Completion Date

November 7, 2018 (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 safety, efficacy, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) for 12 weeks in adults on dialysis for end stage renal disease (ESRD) with chronic hepatitis C virus (HCV) infection of any genotype.

6. Conditions and Keywords

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

Chronic Hepatitis C

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

59 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SOF/VEL

Arm Type

Experimental

Arm Description

SOF/VEL for 12 weeks

Intervention Type

Drug

Intervention Name(s)

SOF/VEL

Other Intervention Name(s)

GS-7977/GS-5816, Epclusa®

Intervention Description

400/100 mg fixed-dose combination (FDC) tablet(s) administered orally once daily

Primary Outcome Measure Information:

Title

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

Description

SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) 12 weeks after stopping the study treatment.

Time Frame

Posttreatment Week 12

Title

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

Time Frame

First dose date up to Week 12

Secondary Outcome Measure Information:

Title

Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4)

Description

SVR4 was defined as HCV RNA < LLOQ 4 weeks after stopping study treatment.

Time Frame

Posttreatment Week 4

Title

Percentage of Participants With Sustained Virologic Response 24 Weeks After Discontinuation of Therapy (SVR24)

Description

SVR24 was defined as HCV RNA < LLOQ 24 weeks after stopping study treatment.

Time Frame

Posttreatment Week 24

Title

Change From Baseline in HCV RNA

Time Frame

Baseline; Weeks 2, 4, 6, 8, and 12

Title

Percentage of Participants With HCV RNA < LLOQ on Treatment

Time Frame

Weeks 2, 4, 6, 8, and 12

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 to Posttreatment Week 24

Title

Number of Participants Who Develop Viral Resistance (as Assessed by Presence of HCV NS5A and NS5B Genes) to SOF and VEL During Treatment and After Discontinuation of Treatment

Description

Baseline deep sequencing of the HCV NS5A and NS5B genes was performed for all participants. For all participants with virologic failure, deep sequencing was performed at the first time point after virologic failure if the plasma or serum sample was available and HCV RNA was > 1000 IU/mL.

Time Frame

First dose date up to Posttreatment Week 24

Title

Pharmacokinetic (PK) Parameter: AUCtau of SOF

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