NCT02722837

Brief Summary

The primary objective of this study is to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks in participants with chronic hepatitis C virus (HCV) infection.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
119

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2016

Geographic Reach
2 countries

15 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

March 24, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 30, 2016

Completed
5 days until next milestone

Study Start

First participant enrolled

April 4, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 13, 2017

Completed
10 months until next milestone

Results Posted

Study results publicly available

July 17, 2018

Completed
Last Updated

November 16, 2018

Status Verified

June 1, 2018

Enrollment Period

1.2 years

First QC Date

March 24, 2016

Results QC Date

June 20, 2018

Last Update Submit

October 19, 2018

Conditions

Hepatitis C Virus Infection

Outcome Measures

Primary Outcomes (2)

  • 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) at 12 weeks after stopping study treatment.

    Posttreatment Week 12

  • Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event

    Up to 12 weeks

Secondary Outcomes (13)

  • Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of Therapy (SVR4)

    Posttreatment Week 4

  • Percentage of Participants With HCV RNA < LLOQ at 24 Weeks After Discontinuation of Therapy (SVR24)

    Posttreatment Week 24

  • Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 1

    Week 1

  • Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 2

    Week 2

  • Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 4

    Week 4

  • +8 more secondary outcomes

Study Arms (1)

SOF/VEL

EXPERIMENTAL

SOF/VEL for 12 weeks

Drug: SOF/VEL

Interventions

SOF/VELDRUG

400/100 mg FDC tablet administered orally once daily

Also known as: GS-7977/GS-5816, Epclusa®
SOF/VEL

Eligibility Criteria

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

You may qualify if:

  • HCV RNA ≥ 10\^4 IU/mL at screening
  • Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy

You may not qualify if:

  • Any other chronic liver disease
  • Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
  • Clinical hepatic decompensation
  • Prior exposure to SOF or other nucleotide analogue HCV NS5B inhibitor or any HCV NS5A inhibitor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Krasnoyarsk Regional Center of AIDS Prevention

Krasnoyarsk, Russia

Location

Central Research Institute of Epidemiology

Moscow, Russia

Location

Central Scientific-Research Institute of Epidemiology

Moscow, Russia

Location

City Clinical Hospital # 24

Moscow, Russia

Location

First Moscow Medical University I.M.Sechenov.

Moscow, Russia

Location

First Moscow State Medical University I.M. Sechenov

Moscow, Russia

Location

Limited Liability Company "Clinic Tour"

Moscow, Russia

Location

Scientific Research Institute of Nutrition

Moscow, Russia

Location

Sklifosovsky Scientific Research Institution of Emergency Care

Moscow, Russia

Location

Center for Prevention and Control of AIDS and Infectious Diseases

Saint Petersburg, Russia

Location

Kirov Medical Military Academy

Saint Petersburg, Russia

Location

North-Western State Medical University named after I.I. Mechnikov

Saint Petersburg, Russia

Location

LLC Medical Company "Hepatolog"

Samara, Russia

Location

Sahlgrenska Universitetsjukhuset

Gothenburg, Sweden

Location

Karolinska University Hospital Huddinge

Stockholm, Sweden

Location

Related Publications (2)

  • Weiland O, Zhdanov K, Chulanov VP, McNabb BL, Lu S, Svarovskaia EU, et al. Safety and Efficacy of Sofosbuvir/Velpatasvir in a Genotype 1-3 HCV Infected Russian and Swedish Population: Results from a Phase 3, Prospective Trial [Abstract 1186]. Hepatology 2017;66 (1):639A.

    BACKGROUND

  • Isakov V, Chulanov V, Abdurakhmanov D, Burnevich E, Nurmukhametova E, Kozhevnikova G, Gankina N, Zhuravel S, Romanova S, Hyland RH, Lu S, Svarovskaia ES, McNally J, Brainard DM, Ivashkin V, Morozov V, Bakulin I, Lagging M, Zhdanov K, Weiland O. Sofosbuvir/velpatasvir for the treatment of HCV: excellent results from a phase-3, open-label study in Russia and Sweden. Infect Dis (Lond). 2019 Feb;51(2):131-139. doi: 10.1080/23744235.2018.1535186. Epub 2018 Nov 30.

    PMID: 30499360DERIVED

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 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2016

First Posted

March 30, 2016

Study Start

April 4, 2016

Primary Completion

June 26, 2017

Study Completion

September 13, 2017

Last Updated

November 16, 2018

Results First Posted

July 17, 2018

Record last verified: 2018-06

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

RU(13)SE(2)