NCT02781558

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
204

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

28 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 24, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

July 29, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2017

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 27, 2017

Completed
1 year until next milestone

Results Posted

Study results publicly available

October 30, 2018

Completed
Last Updated

November 27, 2018

Status Verified

October 1, 2018

Enrollment Period

1.2 years

First QC Date

May 20, 2016

Results QC Date

October 4, 2018

Last Update Submit

October 30, 2018

Conditions

Hepatitis C Virus Infection

Outcome Measures

Primary Outcomes (2)

  • 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.

    Posttreatment Week 12

  • Percentage of Participants Who Permanently Discontinued Any Study Drug (Which Included SOF/VEL and RBV) Due to Any Adverse Event

    Posttreatment Week 12

Secondary Outcomes (14)

  • Percentage of Participants Who Attain Sustained Virologic Response at 4 Weeks After Cessation of the Study Treatment Regimen (SVR4)

    Posttreatment Week 4

  • Percentage of Participants Who Have HCV RNA < LLOQ at Week 2

    Week 2

  • Percentage of Participants Who Have HCV RNA < LLOQ at Week 4

    Week 4

  • Percentage of Participants Who Have HCV RNA < LLOQ at Week 8

    Week 8

  • Percentage of Participants Who Have HCV RNA < LLOQ at Week 12

    Week 12

  • +9 more secondary outcomes

Study Arms (2)

SOF/VEL

EXPERIMENTAL

SOF/VEL FDC for 12 weeks

Drug: SOF/VEL

SOF/VEL + RBV

EXPERIMENTAL

SOF/VEL FDC + RBV for 12 weeks

Drug: SOF/VELDrug: RBV

Interventions

SOF/VELDRUG

400/100 mg FDC tablet administered orally once daily

Also known as: GS-7977/GS-5816, Epclusa®
SOF/VELSOF/VEL + RBV
RBVDRUG

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)

SOF/VEL + RBV

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (28)

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, Spain

Location

Hospital Universitario de A Coruña

A Coruña, Spain

Location

Hospital Universitario Fundacion Alcorcon

Alcorcón, Spain

Location

Hospital General Universitario De Alicante

Alicante, Spain

Location

Complejo Hospitalario Torrecárdenas

Almería, Spain

Location

Hospital Germans Trias i Pujol

Badalona, Spain

Location

Hospital Universitario Valle Hebron

Barcelona, 8035, Spain

Location

Hospital Clínic de Barcelona

Barcelona, Spain

Location

Hospital del Mar

Barcelona, Spain

Location

Hospital Universitari de Bellvitge

Barcelona, Spain

Location

Servei de d'Aparell Digestiu Corporació Sanitària Parc Taulí

Barcelona, Spain

Location

Reina Sofía University Hospital

Córdoba, Spain

Location

Hospital Universitario Donostia

Donostia / San Sebastian, Spain

Location

Hospital Puerta De Hierro Majadahonda

Madrid, Spain

Location

Hospital Ramón y Cajal

Madrid, Spain

Location

Hospital Universitario La Paz

Madrid, Spain

Location

Hospital Universitario Virgen de la Victoria

Málaga, Spain

Location

Hospital Universitario Virgen De La Arrixaca

Murcia, Spain

Location

Hospital Universitario Central de asturias

Oviedo, Spain

Location

Complexo Hospitalario Universitario de Montecelo

Pontevedra, Spain

Location

Hospital Univ. NuestraSeñora Candelaria

Santa Cruz de Tenerife, Spain

Location

Hospital de Valme

Seville, Spain

Location

Hospital Universitario Virgen Del Rocio

Seville, Spain

Location

Hospital Clinico Universitario

Valencia, Spain

Location

Hospital General Valencia

Valencia, Spain

Location

La Fe Hospital

Valencia, Spain

Location

Hospital Universitario Alvaro Cunqueiro

Vigo, Spain

Location

Hospital Clinico Universitario

Zaragoza, Spain

Location

Related Publications (1)

  • 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.

    PMID: 29958855DERIVED

MeSH Terms

Conditions

Hepatitis C

Interventions

sofosbuvir-velpatasvir drug combination

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Results Point of Contact

Title
Gilead Clinical Study Information Center
Organization
Gilead Sciences
GileadClinicalTrials@gilead.com
1-833-445-3230 (GILEAD-0)

Study Officials

  • Gilead Study Director

    Gilead Sciences

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2016

First Posted

May 24, 2016

Study Start

July 29, 2016

Primary Completion

October 6, 2017

Study Completion

October 27, 2017

Last Updated

November 27, 2018

Results First Posted

October 30, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
18 months after study completion
Access Criteria
A secured external environment with username, password, and RSA code.
More information

Locations

ES(28)