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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03036852
Ethics application status
Date submitted
27/01/2017
Date registered
30/01/2017

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
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
Timepoint [1] 0 0
Posttreatment Week 12
Primary outcome [2] 0 0
Percentage of Participants Who Permanently Discontinued the Study Drug Due to an Adverse Event
Timepoint [2] 0 0
First dose date up to Week 12
Secondary outcome [1] 0 0
Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4)
Timepoint [1] 0 0
Posttreatment Week 4
Secondary outcome [2] 0 0
Percentage of Participants With Sustained Virologic Response 24 Weeks After Discontinuation of Therapy (SVR24)
Timepoint [2] 0 0
Posttreatment Week 24
Secondary outcome [3] 0 0
Change From Baseline in HCV RNA
Timepoint [3] 0 0
Baseline; Weeks 2, 4, 6, 8, and 12
Secondary outcome [4] 0 0
Percentage of Participants With HCV RNA < LLOQ on Treatment
Timepoint [4] 0 0
Weeks 2, 4, 6, 8, and 12
Secondary outcome [5] 0 0
Percentage of Participants With Virologic Failure
Timepoint [5] 0 0
Baseline to Posttreatment Week 24
Secondary outcome [6] 0 0
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
Timepoint [6] 0 0
First dose date up to Posttreatment Week 24
Secondary outcome [7] 0 0
Pharmacokinetic (PK) Parameter: AUCtau of SOF
Timepoint [7] 0 0
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))
Secondary outcome [8] 0 0
PK Parameter: AUCtau of GS-331007 (Metabolite of SOF)
Timepoint [8] 0 0
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))
Secondary outcome [9] 0 0
PK Parameter: AUCtau of VEL
Timepoint [9] 0 0
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))
Secondary outcome [10] 0 0
PK Parameter: Cmax of SOF
Timepoint [10] 0 0
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))
Secondary outcome [11] 0 0
PK Parameter: Cmax of GS-331007 (Metabolite of SOF)
Timepoint [11] 0 0
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))
Secondary outcome [12] 0 0
PK Parameter: Cmax of VEL
Timepoint [12] 0 0
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))
Secondary outcome [13] 0 0
PK Parameter: Ctau of VEL
Timepoint [13] 0 0
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))

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
Sex
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
Not applicable
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
22/03/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
7/11/2018
Sample size
Target
Accrual to date
Final
59
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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
18 months after study completion
Available to whom?
A secured external environment with username, password, and RSA code.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy


What supporting documents are/will be available?




Results publications and other study-related documents

TypeCitations or Other Details
Journal Borgia SM, Dearden J, Lurie Y, Shafran SD, Brown A... [More Details]


Results are available at https://clinicaltrials.gov/study/NCT03036852