The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02728206




Registration number
NCT02728206
Ethics application status
Date submitted
31/03/2016
Date registered
5/04/2016
Date last updated
6/02/2019

Titles & IDs
Public title
Sofosbuvir/Velpatasvir Fixed-Dose Combination in HCV-Infected Adults Who Are Undergoing Liver Transplantation
Scientific title
A Phase 2, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir Fixed Dose Combination Administered for Four Weeks in Patients Infected With Chronic HCV in the Peri-Operative Liver Transplantation Setting
Secondary ID [1] 0 0
GS-US-342-2083
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C Virus Infection 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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SOF/VEL

Experimental: SOF/VEL - SOF/VEL FDC for 4 weeks starting on the day of or day after the participant's liver transplant


Treatment: Drugs: SOF/VEL
400/100 mg FDC tablet 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 (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) - SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Timepoint [1] 0 0
Posttreatment Week 12
Primary outcome [2] 0 0
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Timepoint [2] 0 0
Up to Week 4
Secondary outcome [1] 0 0
Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) - SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.
Timepoint [1] 0 0
Posttreatment Week 4
Secondary outcome [2] 0 0
Percentage of Participants With HCV RNA < LLOQ On Treatment
Timepoint [2] 0 0
Days 3, 5, 7, 14, 21, and 28
Secondary outcome [3] 0 0
Percentage of Participants With Overall Virologic Failure - Virologic failure was defined as 1) End of Treatment Virologic Failure: HCV RNA = 15 IU/mL at last observed HCV RNA measurement on or prior to last dose date of SOF/VEL + 3 days after completion of 28 ± 3 days of SOF/VEL treatment, or 2) Relapse: HCV RNA = 15 IU/mL during the posttreatment follow-up period having achieved HCV RNA < 15 IU/mL at the end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement.
Timepoint [3] 0 0
Up to Posttreatment Week 12

Eligibility
Key inclusion criteria
Key

- HCV-infected, male and non-pregnant/non-lactating females, who are undergoing liver
transplantation

Key
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Receiving an HCV-infected liver

- HIV or hepatitis B virus (HBV) co-infected

Note: Other protocol defined Inclusion/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)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

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 the antiviral efficacy, safety, and
tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) in hepatitis C
virus (HCV)-infected adults who are undergoing liver transplantation.
Trial website
https://clinicaltrials.gov/show/NCT02728206
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