Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) Infection
NCT ID: NCT03074331
Last Updated: 2019-03-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
130 participants
INTERVENTIONAL
2017-03-23
2018-02-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SOF/VEL
SOF/VEL for 12 weeks
SOF/VEL
400/100 mg FDC tablet(s) administered orally once daily
Interventions
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SOF/VEL
400/100 mg FDC tablet(s) administered orally once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Seth GS Medical College and KEM hospital
Mumbai, Maharashtra, India
Government Medical College & Super Speciality Hospital
Nagpur, Maharashtra, India
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, India
All India Institute of Medical Sciences
Delhi, New Delhi, India
Global Hospital-Super Speciality & Transpant Centre (A Unite of Centre for Digestive & Kidney Diseases (India) PVT LTD.
Mumbai, Parel, India
Post Graduate Institute of Medical Education and Resesarch (PGIMER)
Chandigarh, Punjab, India
YRG Care
Chennai, Tamil Nadu, India
VGM Hospital - Institute of Gastroenterology
Coimbatore, Tamil Nadu, India
Gandhi Hospital
Secunderabad, Telangana, India
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Lucknow, Uttar Pradesh, India
Department of Hepatology, School of Digestive and Liver Diseases
Kolkata, West Bengal, India
Institute of Digestive and Liver Disease
Guwahati, , India
Global Hospitals
Hyderabad, , India
Lakeshore Hospital
Kochi, , India
Dayanand Medical College & Hospital
Ludhiana, , India
Nirmal Hospital
Surat, , India
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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GS-US-342-1521
Identifier Type: -
Identifier Source: org_study_id
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