Clinical trial NCT03074331: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C Virus Infection
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2017-03-08
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
timeFrame: Posttreatment Week 12
measure: Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
timeFrame: Up to Week 12
Secondary outcomes:
measure: Percentage of Participants With Virologic Failure
timeFrame: Up to Posttreatment Week 12
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver and Biliary Sciences
state: Delhi
city: Mumbai
country: India
facility: Seth GS Medical College and KEM hospital
state: Maharashtra
city: Nagpur
country: India
facility: Government Medical College & Super Speciality Hospital
state: Maharashtra
city: Delhi
country: India
facility: All India Institute of Medical Sciences
state: New Delhi
city: Mumbai
country: India
facility: Global Hospital-Super Speciality & Transpant Centre (A Unite of Centre for Digestive & Kidney Diseases (India) PVT LTD.
state: Parel
city: Chandigarh
country: India
facility: Post Graduate Institute of Medical Education and Resesarch (PGIMER)
state: Punjab
city: Chennai
country: India
facility: YRG Care
state: Tamil Nadu
city: Coimbatore
country: India
facility: VGM Hospital - Institute of Gastroenterology
state: Tamilnadu
city: Secunderabad
country: India
facility: Gandhi Hospital
state: Telangana
city: Lucknow
country: India
facility: Sanjay Gandhi Postgraduate Institute of Medical Sciences
state: Uttar Pradesh
city: Kolkata
country: India
facility: Department of Hepatology, School of Digestive and Liver Diseases
state: West Bengal
city: Guwahati
country: India
facility: Institute of Digestive and Liver Disease
city: Hyderabad
country: India
facility: Global Hospitals
city: Kochi
country: India
facility: Lakeshore Hospital
city: Ludhiana
country: India
facility: Dayanand Medical College & Hospital
city: Surat
country: India
facility: Nirmal Hospital
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: