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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03036852




Registration number
NCT03036852
Ethics application status
Date submitted
27/01/2017
Date registered
30/01/2017
Date last updated
11/12/2018

Titles & IDs
Public title
Sofosbuvir/Velpatasvir in Adults With Chronic Hepatitis C Virus Infection Who Are on Dialysis for End Stage Renal Disease
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
Secondary ID [1] 0 0
2016-003625-42
Secondary ID [2] 0 0
GS-US-342-4062
Universal Trial Number (UTN)
Trial acronym
SOF/VEL ESRD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis c 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Renal and Urogenital 0 0 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) - SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.
Timepoint [1] 0 0
Posttreatment Week 12
Primary outcome [2] 0 0
Proportion of Participants Who Permanently Discontinued the Study Drug Due to an Adverse Event
Timepoint [2] 0 0
Up to Week 12
Secondary outcome [1] 0 0
Proportion of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4) - SVR4 is defined as HCV RNA < LLOQ 4 weeks after the last dose of study drug.
Timepoint [1] 0 0
Posttreatment Week 4
Secondary outcome [2] 0 0
Proportion of Participants With Sustained Virologic Response 24 Weeks After Discontinuation of Therapy (SVR24) - SVR24 is defined as HCV RNA < LLOQ 24 weeks after the last dose of study drug.
Timepoint [2] 0 0
Posttreatment Week 24
Secondary outcome [3] 0 0
Proportion of participants with HCV RNA < LLOQ on treatment
Timepoint [3] 0 0
Up to Week 12
Secondary outcome [4] 0 0
Change From Baseline in HCV RNA
Timepoint [4] 0 0
Up to Week 12
Secondary outcome [5] 0 0
Proportion of Participants With Virologic Failure - Virologic failure is 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.
Timepoint [5] 0 0
Up to Posttreatment Week 24
Secondary outcome [6] 0 0
Proportion of Participants Who Develop Resistance to SOF and VEL During Treatment
Timepoint [6] 0 0
Up to Week 12
Secondary outcome [7] 0 0
Proportion of Participants Who Develop Resistance to SOF and VEL After Discontinuation of Therapy
Timepoint [7] 0 0
Up to Posttreatment Week 24
Secondary outcome [8] 0 0
Pharmacokinetic (PK) Parameter: AUCtau of SOF and its metabolites - AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval)
Timepoint [8] 0 0
Predose and up to 12 hours Postdose
Secondary outcome [9] 0 0
Pharmacokinetic (PK) Parameter: AUCtau of VEL - AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval)
Timepoint [9] 0 0
Predose and up to 12 hours Postdose
Secondary outcome [10] 0 0
Pharmacokinetic (PK) Parameter: Tmax of SOF and its metabolites - Tmax is defined as the time of Cmax (the maximum concentration of drug)
Timepoint [10] 0 0
Predose and up to 12 hours Postdose
Secondary outcome [11] 0 0
Pharmacokinetic (PK) Parameter: Tmax of VEL - Tmax is defined as the time of Cmax (the maximum concentration of drug)
Timepoint [11] 0 0
Predose and up to 12 hours Postdose

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/
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Alberta
Country [2] 0 0
Canada
State/province [2] 0 0
British Columbia
Country [3] 0 0
Canada
State/province [3] 0 0
Ontario
Country [4] 0 0
Canada
State/province [4] 0 0
Quebec
Country [5] 0 0
Israel
State/province [5] 0 0
Jerusalem
Country [6] 0 0
Israel
State/province [6] 0 0
Ramat Gan
Country [7] 0 0
Israel
State/province [7] 0 0
Tel Aviv
Country [8] 0 0
New Zealand
State/province [8] 0 0
Auckland
Country [9] 0 0
Spain
State/province [9] 0 0
Madrid
Country [10] 0 0
Spain
State/province [10] 0 0
Barcelona
Country [11] 0 0
Spain
State/province [11] 0 0
Majadahonda
Country [12] 0 0
Spain
State/province [12] 0 0
Sevilla
Country [13] 0 0
United Kingdom
State/province [13] 0 0
Glasgow
Country [14] 0 0
United Kingdom
State/province [14] 0 0
London
Country [15] 0 0
United Kingdom
State/province [15] 0 0
Nottingham
Country [16] 0 0
United Kingdom
State/province [16] 0 0
Plymouth

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Gilead Sciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary objectives of this study are to evaluate safety, efficacy and tolerability of
treatment with sofosbuvir (Sovaldi®)/velpatasvir (Epclusa®; SOF/VEL) for 12 weeks in adults
with chronic hepatitis C virus (HCV) infection who are on dialysis for End Stage Renal
Disease (ESRD).
Trial website
https://clinicaltrials.gov/show/NCT03036852
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gilead Study Director
Address 0 0
Gilead Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications