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

Hepatitis C Virus Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03074331
• Other study ID #: GS-US-342-1521
• Status: Completed
• Phase: Phase 3
• Start date: March 23, 2017
• Est. completion date: February 7, 2018

Study information

• Verified date: February 2019
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: February 7, 2018
• Est. primary completion date: February 7, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C Virus Infection
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Infection
• Virus Diseases

Intervention

Drug:
• SOF/VEL
400/100 mg FDC tablet(s) administered orally once daily

Locations

Country	Name	City	State
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	Tamilnadu
India	All India Institute of Medical Sciences	Delhi	New Delhi
India	Institute of Digestive and Liver Disease	Guwahati
India	Global Hospitals	Hyderabad
India	Lakeshore Hospital	Kochi
India	Department of Hepatology, School of Digestive and Liver Diseases	Kolkata	West Bengal
India	Sanjay Gandhi Postgraduate Institute of Medical Sciences	Lucknow	Uttar Pradesh
India	Dayanand Medical College & Hospital	Ludhiana
India	Global Hospital-Super Speciality & Transpant Centre (A Unite of Centre for Digestive & Kidney Diseases (India) PVT LTD.	Mumbai	Parel
India	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	Delhi
India	Gandhi Hospital	Secunderabad	Telangana
India	Nirmal Hospital	Surat

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event		Up to Week 12
Secondary	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.	Up to Posttreatment Week 12