Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) Infection
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
1 other identifier
interventional
130
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2017
Shorter than P25 for phase_3
16 active sites
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
February 24, 2017
CompletedFirst Posted
Study publicly available on registry
March 8, 2017
CompletedStudy Start
First participant enrolled
March 23, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 7, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 7, 2018
CompletedResults Posted
Study results publicly available
March 19, 2019
CompletedMarch 19, 2019
February 1, 2019
11 months
February 24, 2017
February 25, 2019
February 25, 2019
Conditions
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; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Posttreatment Week 12
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Up to Week 12
Secondary Outcomes (1)
Percentage of Participants With Virologic Failure
Up to Posttreatment Week 12
Study Arms (1)
SOF/VEL
EXPERIMENTALSOF/VEL for 12 weeks
Interventions
400/100 mg FDC tablet(s) administered orally once daily
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (16)
Seth GS Medical College and KEM hospital
Mumbai, Maharashtra, 400012, India
Government Medical College & Super Speciality Hospital
Nagpur, Maharashtra, 440003, India
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070, India
All India Institute of Medical Sciences
Delhi, New Delhi, 110029, India
Global Hospital-Super Speciality & Transpant Centre (A Unite of Centre for Digestive & Kidney Diseases (India) PVT LTD.
Mumbai, Parel, 400012, India
Post Graduate Institute of Medical Education and Resesarch (PGIMER)
Chandigarh, Punjab, 160012, India
YRG Care
Chennai, Tamil Nadu, 600010, India
VGM Hospital - Institute of Gastroenterology
Coimbatore, Tamil Nadu, 641005, India
Gandhi Hospital
Secunderabad, Telangana, 500003, India
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Lucknow, Uttar Pradesh, 226014, India
Department of Hepatology, School of Digestive and Liver Diseases
Kolkata, West Bengal, 700020, India
Institute of Digestive and Liver Disease
Guwahati, 781006, India
Global Hospitals
Hyderabad, 500004, India
Lakeshore Hospital
Kochi, 682040, India
Dayanand Medical College & Hospital
Ludhiana, 141001, India
Nirmal Hospital
Surat, 395002, India
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gilead Clinical Study Information Center
- Organization
- Gilead Sciences
Study Officials
- STUDY DIRECTOR
Gilead Study Director
Gilead Sciences
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
February 24, 2017
First Posted
March 8, 2017
Study Start
March 23, 2017
Primary Completion
February 7, 2018
Study Completion
February 7, 2018
Last Updated
March 19, 2019
Results First Posted
March 19, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- 18 months after study completion
- Access Criteria
- A secured external environment with username, password, and RSA code.
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.