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Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination (FDC) and Sofosbuvir/Velpatasvir FDC and Ribavirin in Participants With Chronic Genotype 3 HCV Infection and Cirrhosis

Primary Purpose

Hepatitis C Virus Infection

Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
SOF/VEL
RBV
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C Virus Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • Willing and able to provide written informed consent
  • Individuals with chronic genotype 3 HCV infection and compensated cirrhosis
  • Individuals with or without HIV-1 coinfection

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 active hepatitis B virus
  • Laboratory results outside the acceptable ranges at screening
  • Pregnant or nursing female
  • Chronic liver disease not caused by HCV

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Sites / Locations

  • Hospital Universitario Marques de Valdecilla
  • Hospital Universitario Fundacion Alcorcon
  • Hospital General Universitario De Alicante
  • Complejo Hospitalario Torrecárdenas
  • Hospital Germans Trias i Pujol
  • Hospital Universitario Valle Hebron
  • Hospital Clínic de Barcelona
  • Hospital del Mar
  • Hospital Universitari de Bellvitge
  • Servei de d'Aparell Digestiu Corporació Sanitària Parc Taulí
  • Reina Sofía University Hospital
  • Hospital Universitario de A Coruña
  • Hospital Puerta De Hierro Majadahonda
  • Hospital Ramón y Cajal
  • Hospital Universitario La Paz
  • Hospital Universitario Virgen de la Victoria
  • Hospital Universitario Virgen De La Arrixaca
  • Hospital Universitario Central de asturias
  • Complexo Hospitalario Universitario de Montecelo
  • Hospital Universitario Donostia
  • Hospital Univ. NuestraSeñora Candelaria
  • Hospital de Valme
  • Hospital Universitario Virgen Del Rocio
  • Hospital Clinico Universitario
  • Hospital General Valencia
  • La Fe Hospital
  • Hospital Universitario Alvaro Cunqueiro
  • Hospital Clinico Universitario

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

SOF/VEL

SOF/VEL + RBV

Arm Description

SOF/VEL FDC for 12 weeks

SOF/VEL FDC + RBV 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; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Percentage of Participants Who Permanently Discontinued Any Study Drug (Which Included SOF/VEL and RBV) Due to Any Adverse Event

Secondary Outcome Measures

Percentage of Participants Who Attain Sustained Virologic Response at 4 Weeks After Cessation of the Study Treatment Regimen (SVR4)
SVR4 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 4 weeks after stopping study treatment.
Percentage of Participants Who Have HCV RNA < LLOQ at Week 2
Percentage of Participants Who Have HCV RNA < LLOQ at Week 4
Percentage of Participants Who Have HCV RNA < LLOQ at Week 8
Percentage of Participants Who Have 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 8 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

First Posted
May 20, 2016
Last Updated
October 30, 2018
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02781558
Brief Title
Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination (FDC) and Sofosbuvir/Velpatasvir FDC and Ribavirin in Participants With Chronic Genotype 3 HCV Infection and Cirrhosis
Official Title
A Phase 2, Multicenter, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination (FDC) and Sofosbuvir/Velpatasvir FDC and Ribavirin in Subjects With Chronic Genotype 3 HCV Infection and Cirrhosis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
July 29, 2016 (Actual)
Primary Completion Date
October 6, 2017 (Actual)
Study Completion Date
October 27, 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) and SOF/VEL FDC and ribavirin (RBV) for 12 weeks in participants with chronic genotype 3 hepatitis C virus (HCV) infection and compensated cirrhosis.

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
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
204 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SOF/VEL
Arm Type
Experimental
Arm Description
SOF/VEL FDC for 12 weeks
Arm Title
SOF/VEL + RBV
Arm Type
Experimental
Arm Description
SOF/VEL FDC + RBV for 12 weeks
Intervention Type
Drug
Intervention Name(s)
SOF/VEL
Other Intervention Name(s)
GS-7977/GS-5816, Epclusa®
Intervention Description
400/100 mg FDC tablet administered orally once daily
Intervention Type
Drug
Intervention Name(s)
RBV
Intervention Description
RBV tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
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; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Time Frame
Posttreatment Week 12
Title
Percentage of Participants Who Permanently Discontinued Any Study Drug (Which Included SOF/VEL and RBV) Due to Any Adverse Event
Time Frame
Posttreatment Week 12
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Attain Sustained Virologic Response at 4 Weeks After Cessation of the Study Treatment Regimen (SVR4)
Description
SVR4 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 4 weeks after stopping study treatment.
Time Frame
Posttreatment Week 4
Title
Percentage of Participants Who Have HCV RNA < LLOQ at Week 2
Time Frame
Week 2
Title
Percentage of Participants Who Have HCV RNA < LLOQ at Week 4
Time Frame
Week 4
Title
Percentage of Participants Who Have HCV RNA < LLOQ at Week 8
Time Frame
Week 8
Title
Percentage of Participants Who Have 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 8 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: Willing and able to provide written informed consent Individuals with chronic genotype 3 HCV infection and compensated cirrhosis Individuals with or without HIV-1 coinfection 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 active hepatitis B virus Laboratory results outside the acceptable ranges at screening Pregnant or nursing female Chronic liver disease not caused by HCV 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 Universitario Marques de Valdecilla
City
Santander
State/Province
Cantabria
Country
Spain
Facility Name
Hospital Universitario Fundacion Alcorcon
City
Alcorcon
Country
Spain
Facility Name
Hospital General Universitario De Alicante
City
Alicante
Country
Spain
Facility Name
Complejo Hospitalario Torrecárdenas
City
Almeria
Country
Spain
Facility Name
Hospital Germans Trias i Pujol
City
Badalona
Country
Spain
Facility Name
Hospital Universitario Valle Hebron
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Facility Name
Hospital Clínic de Barcelona
City
Barcelona
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
Country
Spain
Facility Name
Hospital Universitari de Bellvitge
City
Barcelona
Country
Spain
Facility Name
Servei de d'Aparell Digestiu Corporació Sanitària Parc Taulí
City
Barcelona
Country
Spain
Facility Name
Reina Sofía University Hospital
City
Cordoba
Country
Spain
Facility Name
Hospital Universitario de A Coruña
City
Coruna
Country
Spain
Facility Name
Hospital Puerta De Hierro Majadahonda
City
Madrid
Country
Spain
Facility Name
Hospital Ramón y Cajal
City
Madrid
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
Country
Spain
Facility Name
Hospital Universitario Virgen de la Victoria
City
Malaga
Country
Spain
Facility Name
Hospital Universitario Virgen De La Arrixaca
City
Murcia
Country
Spain
Facility Name
Hospital Universitario Central de asturias
City
Oviedo
Country
Spain
Facility Name
Complexo Hospitalario Universitario de Montecelo
City
Pontevedra
Country
Spain
Facility Name
Hospital Universitario Donostia
City
San Sebastian
Country
Spain
Facility Name
Hospital Univ. NuestraSeñora Candelaria
City
Santa Cruz de Tenerife
Country
Spain
Facility Name
Hospital de Valme
City
Sevilla
Country
Spain
Facility Name
Hospital Universitario Virgen Del Rocio
City
Sevilla
Country
Spain
Facility Name
Hospital Clinico Universitario
City
Valencia
Country
Spain
Facility Name
Hospital General Valencia
City
Valencia
Country
Spain
Facility Name
La Fe Hospital
City
Valencia
Country
Spain
Facility Name
Hospital Universitario Alvaro Cunqueiro
City
Vigo
Country
Spain
Facility Name
Hospital Clinico Universitario
City
Zaragoza
Country
Spain

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
29958855
Citation
Esteban R, Pineda JA, Calleja JL, Casado M, Rodriguez M, Turnes J, Morano Amado LE, Morillas RM, Forns X, Pascasio Acevedo JM, Andrade RJ, Rivero A, Carrion JA, Lens S, Riveiro-Barciela M, McNabb B, Zhang G, Camus G, Stamm LM, Brainard DM, Subramanian GM, Buti M. Efficacy of Sofosbuvir and Velpatasvir, With and Without Ribavirin, in Patients With Hepatitis C Virus Genotype 3 Infection and Cirrhosis. Gastroenterology. 2018 Oct;155(4):1120-1127.e4. doi: 10.1053/j.gastro.2018.06.042. Epub 2018 Jun 27.
Results Reference
derived

Learn more about this trial

Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination (FDC) and Sofosbuvir/Velpatasvir FDC and Ribavirin in Participants With Chronic Genotype 3 HCV Infection and Cirrhosis

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