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Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination (FDC) and Sofosbuvir/Velpatasvir FDC and Ribavirin in Participants With Chronic Genotype 3 HCV Infection and Cirrhosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02781558
First Posted: May 24, 2016
Last Update Posted: November 21, 2017
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.
Information provided by (Responsible Party):
Gilead Sciences
  Purpose
This study will evaluate the efficacy, safety, and tolerability of sofosbuvir /velpatasvir (SOF/VEL) fixed dose combination (FDC) and SOF/VEL FDC and Ribavirin (RBV) for 12 weeks in participants with chronic genotype 3 HCV infection and compensated cirrhosis.

Condition Intervention Phase
Hepatitis C Virus Infection Drug: SOF/VEL Drug: RBV Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination (FDC) and Sofosbuvir/Velpatasvir FDC and Ribavirin in Subjects With Chronic Genotype 3 HCV Infection and Cirrhosis

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Cessation of Therapy (SVR12) [ Time Frame: Posttreatment Week 12 ]
  • Percentage of Participants Who Permanently Discontinued Study Drug Due to any Adverse Event [ Time Frame: Posttreatment Week 12 ]

Secondary Outcome Measures:
  • Percentage of Participants who Attain Sustained Virologic Response at 4 Weeks after Cessation of the Study Treatment Regimen (SVR4) [ Time Frame: Posttreatment Week 4 ]
  • Percentage of Participants who Have HCV RNA < the Lower Limit of Quantitation (LLOQ) by Visit While on Study Treatment [ Time Frame: Up to 12 weeks ]
  • Absolute and Change from Baseline/Day 1 in HCV RNA Through Week 12 [ Time Frame: Baseline; Week 12 ]
  • Percentage of Participants with Virologic Failure [ Time Frame: Up to Posttreatment Week 12 ]

    Virologic failure is defined as

    • On-treatment virologic failure:

      • Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ on 2 consecutive measurements 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)
    • Virologic 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


Enrollment: 204
Actual Study Start Date: July 29, 2016
Study Completion Date: October 27, 2017
Primary Completion Date: October 6, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SOF/VEL
SOF/VEL FDC for 12 weeks
Drug: SOF/VEL
SOF/VEL (400/100 mg) FDC tablet administered orally once daily
Other Names:
  • GS-7977/GS-5816
  • Epclusa®
Experimental: SOF/VEL + RBV
SOF/VEL FDC + RBV for 12 weeks
Drug: SOF/VEL
SOF/VEL (400/100 mg) FDC tablet administered orally once daily
Other Names:
  • GS-7977/GS-5816
  • Epclusa®
Drug: RBV
RBV tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)

  Eligibility

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.


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

Key Inclusion Criteria:

  • Male and non-pregnant/ non-lactating female individuals
  • Individuals with chronic genotype 3 HCV infection and compensated cirrhosis
  • Laboratory values within threshold at screening
  • Individuals with or without HIV-1 coinfection

Key Exclusion Criteria:

  • History of clinically significant illness or any other medical disorder that may interfere with individual's treatment assessment or compliance with the protocol
  • Co-infection with acute hepatitis B virus
  • Known hypersensitivity to study medication
  • Use of any prohibited concomitant medications as within with window before the Day 1 visit.

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

  Contacts and Locations
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): NCT02781558


Locations
Spain
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, Spain
Hospital Universitario Fundacion Alcorcon
Alcorcon, Spain
Hospital General Universitario De Alicante
Alicante, Spain
Complejo Hospitalario Torrecárdenas
Almeria, Spain
Hospital Germans Trias i Pujol
Badalona, Spain
Hospital Universitario Valle Hebron
Barcelona, Spain, 8035
Hospital Clínic de Barcelona
Barcelona, Spain
Hospital del Mar
Barcelona, Spain
Hospital Universitari de Bellvitge
Barcelona, Spain
Servei de d'Aparell Digestiu Corporació Sanitària Parc Taulí
Barcelona, Spain
Reina Sofía University Hospital
Cordoba, Spain
Hospital Universitario de A Coruña
Coruna, Spain
Hospital Puerta De Hierro Majadahonda
Madrid, Spain
Hospital Ramón y Cajal
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Universitario Virgen de la Victoria
Malaga, Spain
Hospital Universitario Virgen De La Arrixaca
Murcia, Spain
Hospital Universitario Central de asturias
Oviedo, Spain
Complexo Hospitalario Universitario de Montecelo
Pontevedra, Spain
Hospital Universitario Donostia
San Sebastian, Spain
Hospital Univ. NuestraSeñora Candelaria
Santa Cruz de Tenerife, Spain
Hospital de Valme
Sevilla, Spain
Hospital Universitario Virgen Del Rocio
Sevilla, Spain
Hospital Clinico Universitario
Valencia, Spain
Hospital General Valencia
Valencia, Spain
La Fe Hospital
Valencia, Spain
Hospital Universitario Alvaro Cunqueiro
Vigo, Spain
Hospital Clinico Universitario
Zaragoza, Spain
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Gilead Study Director Gilead Sciences
  More Information

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02781558     History of Changes
Other Study ID Numbers: GS-US-342-2097
2016-000417-73 ( EudraCT Number )
First Submitted: May 20, 2016
First Posted: May 24, 2016
Last Update Posted: November 21, 2017
Last Verified: November 2017

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:
Infection
Communicable Diseases
Hepatitis C
Virus Diseases
Hepatitis, Viral, Human
Flaviviridae Infections
RNA Virus Infections
Hepatitis
Liver Diseases
Digestive System Diseases
Ribavirin
Sofosbuvir
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents