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Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) Infection

Primary Purpose

Hepatitis C Virus Infection

Status
Completed
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
SOF/VEL
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
  • HCV RNA detected at screening
  • Chronic HCV infection (≥ 6 months) documented by medical history or liver biopsy
  • Classification as treatment naïve or treatment experienced. Approximately 20% may be treatment-experienced.
  • Cirrhosis determination (approximately 20% may have cirrhosis)
  • Females of childbearing potential must have a negative urine pregnancy test at Screening and on Day 1 prior to enrollment.
  • Male individuals and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as described in the study protocol
  • Lactating females must agree to discontinue nursing before the study drug is administered
  • Adults must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments

Key Exclusion Criteria:

  • Current or prior history of any of the following:

    • Clinically-significant illness (other than HCV) or any other major medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol
    • Clinical hepatic decompensation (ie, ascites, encephalopathy or variceal hemorrhage)
    • Liver transplantation
    • Hepatocellular carcinoma (HCC) (as determined by appropriate imaging at screening for those with cirrhosis) or current malignancy for which the patient is receiving treatment or which may interfere with individual's treatment, assessment or compliance with the protocol.
  • Screening laboratory parameters outside of defined threshold
  • Prior exposure to HCV NS5A inhibitor
  • Pregnant or nursing female
  • Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
  • Use of any prohibited concomitant medications as described in study protocol
  • Known hypersensitivity to VEL, SOF, or formulation excipients

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

Sites / Locations

  • Institute of Liver and Biliary Sciences
  • Seth GS Medical College and KEM hospital
  • Government Medical College & Super Speciality Hospital
  • All India Institute of Medical Sciences
  • Global Hospital-Super Speciality & Transpant Centre (A Unite of Centre for Digestive & Kidney Diseases (India) PVT LTD.
  • Post Graduate Institute of Medical Education and Resesarch (PGIMER)
  • YRG Care
  • VGM Hospital - Institute of Gastroenterology
  • Gandhi Hospital
  • Sanjay Gandhi Postgraduate Institute of Medical Sciences
  • Department of Hepatology, School of Digestive and Liver Diseases
  • Institute of Digestive and Liver Disease
  • Global Hospitals
  • Lakeshore Hospital
  • Dayanand Medical College & Hospital
  • Nirmal Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SOF/VEL

Arm Description

SOF/VEL for 12 weeks

Outcomes

Primary Outcome Measures

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; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

Secondary Outcome Measures

Percentage of Participants With Virologic Failure
Virologic failure was defined as the following: On Treatment Virologic Failure: HCV RNA persistently ≥ LLOQ through 12 weeks of treatment (nonresponse), or Relapse: HCV RNA ≥ LLOQ at Posttreatment Week 12 having achieved HCV RNA < LLOQ at end of treatment.

Full Information

First Posted
February 24, 2017
Last Updated
February 25, 2019
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03074331
Brief Title
Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) Infection
Official Title
A Phase 3, Open-label Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Subjects With Chronic Hepatitis C Virus (HCV) Infection
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
March 23, 2017 (Actual)
Primary Completion Date
February 7, 2018 (Actual)
Study Completion Date
February 7, 2018 (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 treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks in adults with chronic hepatitis C virus (HCV) infection.

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 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SOF/VEL
Arm Type
Experimental
Arm Description
SOF/VEL 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 FDC tablet(s) administered orally once daily
Primary Outcome Measure Information:
Title
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation 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 Due to an Adverse Event
Time Frame
Up to Week 12
Secondary Outcome Measure Information:
Title
Percentage of Participants With Virologic Failure
Description
Virologic failure was defined as the following: On Treatment Virologic Failure: HCV RNA persistently ≥ LLOQ through 12 weeks of treatment (nonresponse), or Relapse: HCV RNA ≥ LLOQ at Posttreatment Week 12 having achieved HCV RNA < LLOQ at end of treatment.
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 HCV RNA detected at screening Chronic HCV infection (≥ 6 months) documented by medical history or liver biopsy Classification as treatment naïve or treatment experienced. Approximately 20% may be treatment-experienced. Cirrhosis determination (approximately 20% may have cirrhosis) Females of childbearing potential must have a negative urine pregnancy test at Screening and on Day 1 prior to enrollment. Male individuals and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as described in the study protocol Lactating females must agree to discontinue nursing before the study drug is administered Adults must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments Key Exclusion Criteria: Current or prior history of any of the following: Clinically-significant illness (other than HCV) or any other major medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol Clinical hepatic decompensation (ie, ascites, encephalopathy or variceal hemorrhage) Liver transplantation Hepatocellular carcinoma (HCC) (as determined by appropriate imaging at screening for those with cirrhosis) or current malignancy for which the patient is receiving treatment or which may interfere with individual's treatment, assessment or compliance with the protocol. Screening laboratory parameters outside of defined threshold Prior exposure to HCV NS5A inhibitor Pregnant or nursing female Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV) Use of any prohibited concomitant medications as described in study protocol Known hypersensitivity to VEL, SOF, or formulation excipients 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
Institute of Liver and Biliary Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110070
Country
India
Facility Name
Seth GS Medical College and KEM hospital
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400012
Country
India
Facility Name
Government Medical College & Super Speciality Hospital
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440003
Country
India
Facility Name
All India Institute of Medical Sciences
City
Delhi
State/Province
New Delhi
ZIP/Postal Code
110029
Country
India
Facility Name
Global Hospital-Super Speciality & Transpant Centre (A Unite of Centre for Digestive & Kidney Diseases (India) PVT LTD.
City
Mumbai
State/Province
Parel
ZIP/Postal Code
400012
Country
India
Facility Name
Post Graduate Institute of Medical Education and Resesarch (PGIMER)
City
Chandigarh
State/Province
Punjab
ZIP/Postal Code
160012
Country
India
Facility Name
YRG Care
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600010
Country
India
Facility Name
VGM Hospital - Institute of Gastroenterology
City
Coimbatore
State/Province
Tamilnadu
ZIP/Postal Code
641005
Country
India
Facility Name
Gandhi Hospital
City
Secunderabad
State/Province
Telangana
ZIP/Postal Code
500003
Country
India
Facility Name
Sanjay Gandhi Postgraduate Institute of Medical Sciences
City
Lucknow
State/Province
Uttar Pradesh
ZIP/Postal Code
226014
Country
India
Facility Name
Department of Hepatology, School of Digestive and Liver Diseases
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700020
Country
India
Facility Name
Institute of Digestive and Liver Disease
City
Guwahati
ZIP/Postal Code
781006
Country
India
Facility Name
Global Hospitals
City
Hyderabad
ZIP/Postal Code
500004
Country
India
Facility Name
Lakeshore Hospital
City
Kochi
ZIP/Postal Code
682040
Country
India
Facility Name
Dayanand Medical College & Hospital
City
Ludhiana
ZIP/Postal Code
141001
Country
India
Facility Name
Nirmal Hospital
City
Surat
ZIP/Postal Code
395002
Country
India

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

Learn more about this trial

Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) Infection

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