Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) Infection
- Registration Number
- NCT03074331
- Lead Sponsor
- Gilead Sciences
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 130
- 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
-
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SOF/VEL SOF/VEL SOF/VEL for 12 weeks
- Primary Outcome Measures
Name Time Method Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) Posttreatment Week 12 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 Up to Week 12
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Virologic Failure Up to Posttreatment Week 12 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.
Trial Locations
- Locations (16)
Institute of Digestive and Liver Disease
🇮🇳Guwahati, India
YRG Care
🇮🇳Chennai, Tamil Nadu, India
All India Institute of Medical Sciences
🇮🇳Delhi, New Delhi, India
Post Graduate Institute of Medical Education and Resesarch (PGIMER)
🇮🇳Chandigarh, Punjab, India
Lakeshore Hospital
🇮🇳Kochi, India
Dayanand Medical College & Hospital
🇮🇳Ludhiana, India
Global Hospitals
🇮🇳Hyderabad, India
Global Hospital-Super Speciality & Transpant Centre (A Unite of Centre for Digestive & Kidney Diseases (India) PVT LTD.
🇮🇳Mumbai, Parel, India
Sanjay Gandhi Postgraduate Institute of Medical Sciences
🇮🇳Lucknow, Uttar Pradesh, India
VGM Hospital - Institute of Gastroenterology
🇮🇳Coimbatore, Tamilnadu, India
Gandhi Hospital
🇮🇳Secunderabad, Telangana, India
Nirmal Hospital
🇮🇳Surat, India
Government Medical College & Super Speciality Hospital
🇮🇳Nagpur, Maharashtra, India
Seth GS Medical College and KEM hospital
🇮🇳Mumbai, Maharashtra, India
Department of Hepatology, School of Digestive and Liver Diseases
🇮🇳Kolkata, West Bengal, India
Institute of Liver and Biliary Sciences
🇮🇳New Delhi, Delhi, India