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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03036852
Registration number
NCT03036852
Ethics application status
Date submitted
27/01/2017
Date registered
30/01/2017
Date last updated
6/03/2020
Titles & IDs
Public title
Sofosbuvir/Velpatasvir in Adults With Chronic Hepatitis C Virus Infection Who Are on Dialysis for End Stage Renal Disease
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Scientific 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
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Secondary ID [1]
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2016-003625-42
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Secondary ID [2]
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GS-US-342-4062
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Universal Trial Number (UTN)
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Trial acronym
SOF/VEL ESRD
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis C
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Condition category
Condition code
Infection
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Other infectious diseases
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Renal and Urogenital
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Kidney disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - SOF/VEL
Experimental: SOF/VEL - SOF/VEL for 12 weeks
Treatment: Drugs: SOF/VEL
400/100 mg fixed-dose combination (FDC) tablet(s) administered orally once daily
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
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Assessment method [1]
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SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) 12 weeks after stopping the study treatment.
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Timepoint [1]
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Posttreatment Week 12
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Primary outcome [2]
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Percentage of Participants Who Permanently Discontinued the Study Drug Due to an Adverse Event
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Assessment method [2]
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Timepoint [2]
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First dose date up to Week 12
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Secondary outcome [1]
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Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4)
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Assessment method [1]
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SVR4 was defined as HCV RNA < LLOQ 4 weeks after stopping study treatment.
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Timepoint [1]
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Posttreatment Week 4
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Secondary outcome [2]
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Percentage of Participants With Sustained Virologic Response 24 Weeks After Discontinuation of Therapy (SVR24)
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Assessment method [2]
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SVR24 was defined as HCV RNA < LLOQ 24 weeks after stopping study treatment.
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Timepoint [2]
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Posttreatment Week 24
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Secondary outcome [3]
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Change From Baseline in HCV RNA
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Assessment method [3]
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Timepoint [3]
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Baseline; Weeks 2, 4, 6, 8, and 12
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Secondary outcome [4]
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Percentage of Participants With HCV RNA < LLOQ on Treatment
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Assessment method [4]
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Timepoint [4]
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Weeks 2, 4, 6, 8, and 12
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Secondary outcome [5]
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Percentage of Participants With Virologic Failure
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Assessment method [5]
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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
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Timepoint [5]
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Baseline to Posttreatment Week 24
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Secondary outcome [6]
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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
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Assessment method [6]
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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.
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Timepoint [6]
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First dose date up to Posttreatment Week 24
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Secondary outcome [7]
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Pharmacokinetic (PK) Parameter: AUCtau of SOF
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Assessment method [7]
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AUCtau is defined as the population PK derived area under the concentration versus time curve of the drug over the dosing interval.
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Timepoint [7]
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Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
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Secondary outcome [8]
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PK Parameter: AUCtau of GS-331007 (Metabolite of SOF)
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Assessment method [8]
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AUCtau is defined as the population PK derived area under the concentration versus time curve of the drug over the dosing interval.
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Timepoint [8]
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Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
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Secondary outcome [9]
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PK Parameter: AUCtau of VEL
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Assessment method [9]
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AUCtau is defined as the population PK derived area under the concentration verses time curve of the drug over the dosing interval.
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Timepoint [9]
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Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
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Secondary outcome [10]
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PK Parameter: Cmax of SOF
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Assessment method [10]
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Cmax is defined as the population PK derived maximum concentration of the drug.
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Timepoint [10]
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Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
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Secondary outcome [11]
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PK Parameter: Cmax of GS-331007 (Metabolite of SOF)
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Assessment method [11]
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Cmax is defined as the population PK derived maximum concentration of the drug.
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Timepoint [11]
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Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
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Secondary outcome [12]
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PK Parameter: Cmax of VEL
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Assessment method [12]
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Cmax is defined as the population PK derived maximum concentration of the drug.
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Timepoint [12]
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Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
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Secondary outcome [13]
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PK Parameter: Ctau of VEL
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Assessment method [13]
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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.
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Timepoint [13]
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Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
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Eligibility
Key inclusion criteria
Key
- 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/
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
22/03/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
7/11/2018
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Sample size
Target
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Accrual to date
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Final
59
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
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Royal Adelaide Hospital - Adelaide
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Recruitment outside Australia
Country [1]
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Canada
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State/province [1]
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Alberta
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Country [2]
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Canada
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State/province [2]
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British Columbia
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Country [3]
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Canada
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State/province [3]
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Ontario
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Country [4]
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Canada
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State/province [4]
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Quebec
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Country [5]
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Israel
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State/province [5]
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Jerusalem
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Country [6]
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Israel
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State/province [6]
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Ramat Gan
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Country [7]
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Israel
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State/province [7]
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Tel Aviv
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Country [8]
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New Zealand
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State/province [8]
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Auckland
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Country [9]
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Spain
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State/province [9]
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Madrid
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Country [10]
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Spain
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State/province [10]
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Barcelona
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Country [11]
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Spain
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State/province [11]
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Majadahonda
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Country [12]
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Spain
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State/province [12]
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Sevilla
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Country [13]
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United Kingdom
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State/province [13]
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Glasgow
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Country [14]
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United Kingdom
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State/province [14]
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London
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Country [15]
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United Kingdom
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State/province [15]
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Nottingham
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Country [16]
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United Kingdom
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State/province [16]
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Plymouth
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Gilead Sciences
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03036852
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Gilead Study Director
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Address
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Gilead Sciences
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03036852
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