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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03074331
Recruitment Status : Completed
First Posted : March 8, 2017
Results First Posted : March 19, 2019
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hepatitis C Virus Infection Drug: SOF/VEL Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 23, 2017
Actual Primary Completion Date : February 7, 2018
Actual Study Completion Date : February 7, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Sofosbuvir

Arms and Interventions
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Arm Intervention/treatment
Experimental: SOF/VEL
SOF/VEL for 12 weeks
 Drug: SOF/VEL
400/100 mg FDC tablet(s) administered orally once daily
Other Names:
  • Epclusa®
  • GS-7977/GS-5816


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) [ Time Frame: 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.

  2. Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event [ Time Frame: Up to Week 12 ]

Secondary Outcome Measures :
  1. Percentage of Participants With Virologic Failure [ Time Frame: 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03074331


Locations
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India
Institute of Liver and Biliary Sciences
New Delhi, Delhi, India, 110070
Seth GS Medical College and KEM hospital
Mumbai, Maharashtra, India, 400012
Government Medical College & Super Speciality Hospital
Nagpur, Maharashtra, India, 440003
All India Institute of Medical Sciences
Delhi, New Delhi, India, 110029
Global Hospital-Super Speciality & Transpant Centre (A Unite of Centre for Digestive & Kidney Diseases (India) PVT LTD.
Mumbai, Parel, India, 400012
Post Graduate Institute of Medical Education and Resesarch (PGIMER)
Chandigarh, Punjab, India, 160012
YRG Care
Chennai, Tamil Nadu, India, 600010
VGM Hospital - Institute of Gastroenterology
Coimbatore, Tamilnadu, India, 641005
Gandhi Hospital
Secunderabad, Telangana, India, 500003
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Lucknow, Uttar Pradesh, India, 226014
Department of Hepatology, School of Digestive and Liver Diseases
Kolkata, West Bengal, India, 700020
Institute of Digestive and Liver Disease
Guwahati, India, 781006
Global Hospitals
Hyderabad, India, 500004
Lakeshore Hospital
Kochi, India, 682040
Dayanand Medical College & Hospital
Ludhiana, India, 141001
Nirmal Hospital
Surat, India, 395002
Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences
  Study Documents (Full-Text)

Documents provided by Gilead Sciences:
Study Protocol  [PDF] February 12, 2016
Statistical Analysis Plan  [PDF] March 14, 2018

More Information
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT03074331    
Other Study ID Numbers: GS-US-342-1521
First Posted: March 8, 2017    Key Record Dates
Results First Posted: March 19, 2019
Last Update Posted: March 19, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: 18 months after study completion
Access Criteria: A secured external environment with username, password, and RSA code.
URL: http://www.gilead.com/research/disclosure-and-transparency

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Disease Attributes
Pathologic Processes
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
 Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Flaviviridae Infections
Hepatitis, Chronic
Sofosbuvir
Sofosbuvir-velpatasvir drug combination
Velpatasvir
Antiviral Agents
Anti-Infective Agents