Sofosbuvir/Velpatasvir Fixed Dose Combination in Participants With Chronic Hepatitis C Virus Infection Who Have Received a Liver Transplant
Primary Purpose
Hepatitis C Virus Infection
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
SOF/VEL
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C Virus Infection
Eligibility Criteria
Key Inclusion Criteria:
- History of chronic HCV infection (≥ 6 months)
- HCV genotype 1, 2, 3, 4, 5, 6, or indeterminate
- Liver transplant ≥ 3 months prior to screening
- Male and nonpregnant/ non-lactating female individuals without cirrhosis or with compensated cirrhosis
Key Exclusion Criteria:
- History of clinically significant illness or any other medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol,
- Co-infection with HIV or hepatitis B virus
- Known hypersensitivity to study medication,
- Use of any prohibited concomitant medications as within with window before the Day 1 visit.
- De novo or recurrent hepatocellular carcinoma posttransplant
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Sites / Locations
- Hospital Clínic de Barcelona
- Hospital Universitari Vall d'Hebron
- Reina Sofía University Hospital
- Hospital General Universitario Gregorio Maranon
- Hospital Ramón Y Cajal
- Hospital Universitario Virgen del Rocío
- La Fe Hospital
- Hospital Clinico Zaragoza
- Universität Bern
- University Hospital Zurich
- Cambridge University Hospitals NHS Foundation Trust
- Royal Infirmary of Edinburgh
- St James University Hospital
- Kings College Hospital
- Royal Free Hampstead NHS Trust
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SOF/VEL
Arm Description
SOF/VEL FDC for 12 weeks
Outcomes
Primary Outcome Measures
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Cessation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment.
Percentage of Participants Who Prematurely Discontinued Study Drug Due to Any Adverse Event
Secondary Outcome Measures
Percentage of Participants With Sustained Virologic Response 4 Weeks After Cessation of Therapy (SVR4)
SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.
Percentage of Participants With HCV RNA < LLOQ at Week 2
Percentage of Participants With HCV RNA < LLOQ at Week 4
Percentage of Participants With HCV RNA < LLOQ at Week 8
Percentage of Participants With HCV RNA < LLOQ at Week 12
HCV RNA at Week 2
HCV RNA at Week 4
HCV RNA at Week 8
HCV RNA at Week 12
Change From Baseline in HCV RNA at Week 2
Change From Baseline in HCV RNA at Week 4
Change From Baseline in HCV RNA at Week 8
Change From Baseline in HCV RNA at Week 12
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 on 2 consecutive measurements 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 12 weeks of treatment)
Virologic relapse:
HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02781571
Brief Title
Sofosbuvir/Velpatasvir Fixed Dose Combination in Participants With Chronic Hepatitis C Virus Infection Who Have Received a Liver Transplant
Official Title
A Phase 2, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination in Subjects With Chronic HCV Infection Who Have Received a Liver Transplant
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
July 27, 2016 (Actual)
Primary Completion Date
July 28, 2017 (Actual)
Study Completion Date
July 28, 2017 (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
No
5. Study Description
Brief Summary
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir /velpatasvir (SOF/VEL) fixed-dose combination (FDC) in participants with chronic hepatitis C virus (HCV) who have received a liver transplant.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C Virus Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
79 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SOF/VEL
Arm Type
Experimental
Arm Description
SOF/VEL FDC for 12 weeks
Intervention Type
Drug
Intervention Name(s)
SOF/VEL
Other Intervention Name(s)
Epclusa®, GS-7977/GS-5816
Intervention Description
400/100 mg tablet administered orally once daily
Primary Outcome Measure Information:
Title
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Cessation of Therapy (SVR12)
Description
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment.
Time Frame
Posttreatment Week 12
Title
Percentage of Participants Who Prematurely Discontinued Study Drug Due to Any Adverse Event
Time Frame
Up to 12 weeks
Secondary Outcome Measure Information:
Title
Percentage of Participants With Sustained Virologic Response 4 Weeks After Cessation of Therapy (SVR4)
Description
SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.
Time Frame
Posttreatment Week 4
Title
Percentage of Participants With HCV RNA < LLOQ at Week 2
Time Frame
Week 2
Title
Percentage of Participants With HCV RNA < LLOQ at Week 4
Time Frame
Week 4
Title
Percentage of Participants With HCV RNA < LLOQ at Week 8
Time Frame
Week 8
Title
Percentage of Participants With HCV RNA < LLOQ at Week 12
Time Frame
Week 12
Title
HCV RNA at Week 2
Time Frame
Week 2
Title
HCV RNA at Week 4
Time Frame
Week 4
Title
HCV RNA at Week 8
Time Frame
Week 8
Title
HCV RNA at Week 12
Time Frame
Week 12
Title
Change From Baseline in HCV RNA at Week 2
Time Frame
Baseline; Week 2
Title
Change From Baseline in HCV RNA at Week 4
Time Frame
Baseline; Week 4
Title
Change From Baseline in HCV RNA at Week 8
Time Frame
Baseline; Week 8
Title
Change From Baseline in HCV RNA at Week 12
Time Frame
Baseline; Week 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 on 2 consecutive measurements 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 12 weeks of treatment)
Virologic relapse:
HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement
Time Frame
Up to Posttreatment Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
History of chronic HCV infection (≥ 6 months)
HCV genotype 1, 2, 3, 4, 5, 6, or indeterminate
Liver transplant ≥ 3 months prior to screening
Male and nonpregnant/ non-lactating female individuals without cirrhosis or with compensated cirrhosis
Key Exclusion Criteria:
History of clinically significant illness or any other medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol,
Co-infection with HIV or hepatitis B virus
Known hypersensitivity to study medication,
Use of any prohibited concomitant medications as within with window before the Day 1 visit.
De novo or recurrent hepatocellular carcinoma posttransplant
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilead Study Director
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Clínic de Barcelona
City
Barcelona
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
Country
Spain
Facility Name
Reina Sofía University Hospital
City
Córdoba
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranon
City
Madrid
Country
Spain
Facility Name
Hospital Ramón Y Cajal
City
Madrid
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocío
City
Sevilla
Country
Spain
Facility Name
La Fe Hospital
City
Valencia
Country
Spain
Facility Name
Hospital Clinico Zaragoza
City
Zaragoza
Country
Spain
Facility Name
Universität Bern
City
Bern
Country
Switzerland
Facility Name
University Hospital Zurich
City
Zürich
Country
Switzerland
Facility Name
Cambridge University Hospitals NHS Foundation Trust
City
Cambridge
Country
United Kingdom
Facility Name
Royal Infirmary of Edinburgh
City
Edinburgh
Country
United Kingdom
Facility Name
St James University Hospital
City
Leeds
Country
United Kingdom
Facility Name
Kings College Hospital
City
London
Country
United Kingdom
Facility Name
Royal Free Hampstead NHS Trust
City
London
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.
IPD Sharing Time Frame
18 months after study completion
IPD Sharing Access Criteria
A secured external environment with username, password, and RSA code.
IPD Sharing URL
http://www.gilead.com/research/disclosure-and-transparency
Citations:
PubMed Identifier
29886154
Citation
Agarwal K, Castells L, Mullhaupt B, Rosenberg WMC, McNabb B, Arterburn S, Camus G, McNally J, Stamm LM, Brainard DM, Mani Subramanian G, Marino Z, Dufour JF, Forns X. Sofosbuvir/velpatasvir for 12 weeks in genotype 1-4 HCV-infected liver transplant recipients. J Hepatol. 2018 Sep;69(3):603-607. doi: 10.1016/j.jhep.2018.05.039. Epub 2018 Jun 8.
Results Reference
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Sofosbuvir/Velpatasvir Fixed Dose Combination in Participants With Chronic Hepatitis C Virus Infection Who Have Received a Liver Transplant
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