Sofosbuvir/Velpatasvir Fixed Dose Combination in Participants With Chronic Hepatitis C Virus Infection Who Have Received a Liver Transplant

Hepatitis C Virus Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02781571
• Other study ID #: GS-US-342-2104
• Secondary ID: 2016-000416-15
• Status: Completed
• Phase: Phase 2
• Start date: July 27, 2016
• Est. completion date: July 28, 2017

Study information

• Verified date: July 2018
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: July 28, 2017
• Est. primary completion date: July 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Hepatitis
• Hepatitis C
• Hepatitis C Virus Infection
• Infection
• Virus Diseases

Intervention

Drug:
• SOF/VEL
400/100 mg tablet administered orally once daily

Locations

Country	Name	City	State
Spain	Hospital Clínic de Barcelona	Barcelona
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Reina Sofía University Hospital	Córdoba
Spain	Hospital General Universitario Gregorio Maranon	Madrid
Spain	Hospital Ramón Y Cajal	Madrid
Spain	Hospital Universitario Virgen del Rocío	Sevilla
Spain	La Fe Hospital	Valencia
Spain	Hospital Clinico Zaragoza	Zaragoza
Switzerland	Universität Bern	Bern
Switzerland	University Hospital Zurich	Zürich
United Kingdom	Cambridge University Hospitals NHS Foundation Trust	Cambridge
United Kingdom	Royal Infirmary of Edinburgh	Edinburgh
United Kingdom	St James University Hospital	Leeds
United Kingdom	Kings College Hospital	London
United Kingdom	Royal Free Hampstead NHS Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

Spain,  Switzerland,  United Kingdom, 

References & Publications (1)

Agarwal K, Castells L, Müllhaupt B, Rosenberg WMC, McNabb B, Arterburn S, Camus G, McNally J, Stamm LM, Brainard DM, Mani Subramanian G, Mariño 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Posttreatment Week 12
Primary	Percentage of Participants Who Prematurely Discontinued Study Drug Due to Any Adverse Event		Up to 12 weeks
Secondary	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.	Posttreatment Week 4
Secondary	Percentage of Participants With HCV RNA < LLOQ at Week 2		Week 2
Secondary	Percentage of Participants With HCV RNA < LLOQ at Week 4		Week 4
Secondary	Percentage of Participants With HCV RNA < LLOQ at Week 8		Week 8
Secondary	Percentage of Participants With HCV RNA < LLOQ at Week 12		Week 12
Secondary	HCV RNA at Week 2		Week 2
Secondary	HCV RNA at Week 4		Week 4
Secondary	HCV RNA at Week 8		Week 8
Secondary	HCV RNA at Week 12		Week 12
Secondary	Change From Baseline in HCV RNA at Week 2		Baseline; Week 2
Secondary	Change From Baseline in HCV RNA at Week 4		Baseline; Week 4
Secondary	Change From Baseline in HCV RNA at Week 8		Baseline; Week 8
Secondary	Change From Baseline in HCV RNA at Week 12		Baseline; Week 12
Secondary	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	Up to Posttreatment Week 12