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Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination in Participants With Chronic Hepatitis C Virus 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: NCT02722837
Recruitment Status : Completed
First Posted : March 30, 2016
Results First Posted : July 17, 2018
Last Update Posted : November 16, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
The primary objective of this study is to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks in participants with chronic hepatitis C virus (HCV) infection.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 119 participants
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 : April 4, 2016
Actual Primary Completion Date : June 26, 2017
Actual Study Completion Date : September 13, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Sofosbuvir

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




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) at 12 weeks after stopping study treatment.

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

Secondary Outcome Measures :
  1. Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of Therapy (SVR4) [ Time Frame: Posttreatment Week 4 ]
    SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.

  2. Percentage of Participants With HCV RNA < LLOQ at 24 Weeks After Discontinuation of Therapy (SVR24) [ Time Frame: Posttreatment Week 24 ]
    SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.

  3. Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 1 [ Time Frame: Week 1 ]
  4. Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 2 [ Time Frame: Week 2 ]
  5. Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 4 [ Time Frame: Week 4 ]
  6. Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 8 [ Time Frame: Week 8 ]
  7. Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 12 [ Time Frame: Week 12 ]
  8. Change From Baseline in HCV RNA at Week 1 [ Time Frame: Baseline (Day 1); Week 1 ]
  9. Change From Baseline in HCV RNA at Week 2 [ Time Frame: Baseline (Day 1); Week 2 ]
  10. Change From Baseline in HCV RNA at Week 4 [ Time Frame: Baseline (Day 1); Week 4 ]
  11. Change From Baseline in HCV RNA at Week 8 [ Time Frame: Baseline (Day 1); Week 8 ]
  12. Change From Baseline in HCV RNA at Week 12 [ Time Frame: Baseline (Day 1); Week 12 ]
  13. Percentage of Participants With Virologic Failure [ Time Frame: Up to Posttreatment Week 24 ]

    Virologic failure was defined as:

    • Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
    • Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
    • Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment), or
    • Relapse (HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement)



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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:

  • HCV RNA ≥ 10^4 IU/mL at screening
  • Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy

Key Exclusion Criteria:

  • Any other chronic liver disease
  • Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
  • Clinical hepatic decompensation
  • Prior exposure to SOF or other nucleotide analogue HCV NS5B inhibitor or any HCV NS5A inhibitor

Note: Other protocol defined Inclusion/ Exclusion criteria may apply.


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): NCT02722837


Locations
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Russian Federation
Krasnoyarsk Regional Center of AIDS Prevention
Krasnoyarsk, Russian Federation
Central Research Institute of Epidemiology
Moscow, Russian Federation
Central Scientific-Research Institute of Epidemiology
Moscow, Russian Federation
City Clinical Hospital # 24
Moscow, Russian Federation
First Moscow Medical University I.M.Sechenov.
Moscow, Russian Federation
First Moscow State Medical University I.M. Sechenov
Moscow, Russian Federation
Limited Liability Company "Clinic Tour"
Moscow, Russian Federation
Scientific Research Institute of Nutrition
Moscow, Russian Federation
Sklifosovsky Scientific Research Institution of Emergency Care
Moscow, Russian Federation
Center for Prevention and Control of AIDS and Infectious Diseases
Saint Petersburg, Russian Federation
Kirov Medical Military Academy
Saint Petersburg, Russian Federation
North-Western State Medical University named after I.I. Mechnikov
Saint Petersburg, Russian Federation
LLC Medical Company "Hepatolog"
Samara, Russian Federation
Sweden
Sahlgrenska Universitetsjukhuset
Göteborg, Sweden
Karolinska University Hospital Huddinge
Stockholm, Sweden
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: Original  [PDF] July 17, 2015
Study Protocol: Amendment 1  [PDF] December 3, 2015
Statistical Analysis Plan  [PDF] August 17, 2017


Publications:
Weiland O, Zhdanov K, Chulanov VP, McNabb BL, Lu S, Svarovskaia EU, et al. Safety and Efficacy of Sofosbuvir/Velpatasvir in a Genotype 1-3 HCV Infected Russian and Swedish Population: Results from a Phase 3, Prospective Trial [Abstract 1186]. Hepatology 2017;66 (1):639A.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02722837     History of Changes
Other Study ID Numbers: GS-US-342-1522
2015-003001-42 ( EudraCT Number )
First Posted: March 30, 2016    Key Record Dates
Results First Posted: July 17, 2018
Last Update Posted: November 16, 2018
Last Verified: June 2018
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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Infection
Communicable Diseases
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Hepatitis, Chronic
Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Sofosbuvir
Velpatasvir
Sofosbuvir-velpatasvir drug combination
Antiviral Agents
Anti-Infective Agents