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Study to Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavarin (CPTC)

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ClinicalTrials.gov Identifier: NCT02994056
Recruitment Status : Completed
First Posted : December 15, 2016
Last Update Posted : December 20, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of the treatment with sofosbuvir velpatasvir (SOF/VEL) fixed-dose combination (FDC) with ribavirin (RBV) for 12 weeks in participants with chronic hepatitis C virus (HCV) infection and Child-Pugh-Turcotte (CPT) class C cirrhosis.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 Weeks in Subjects With Chronic HCV Infection and Child-Pugh-Turcotte Class C Cirrhosis
Actual Study Start Date : January 23, 2017
Actual Primary Completion Date : September 25, 2018
Actual Study Completion Date : December 12, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hepatitis C
Drug Information available for: Sofosbuvir

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

Drug: RBV
Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)




Primary Outcome Measures :
  1. Proportion of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) [ Time Frame: Posttreatment Week 12 ]
    SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment.

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

Secondary Outcome Measures :
  1. Proportion of Participants With Sustained Virologic Response (SVR) 4 Weeks After Discontinuation of Therapy (SVR4) [ Time Frame: Posttreatment Week 4 ]
    SVR4 is defined as HCV RNA < the lower limit of quantitation (LLOQ) at 4 weeks after stopping study treatment.

  2. Proportion of Participants With Sustained Virologic Response (SVR) 24 Weeks After Discontinuation of Therapy (SVR24) [ Time Frame: Posttreatment Week 24 ]
    SVR24 is defined as HCV RNA < the LLOQ at 24 weeks after stopping study treatment.

  3. Proportion of Participants With HCV RNA < LLOQ While on Study Treatment [ Time Frame: Up to 12 weeks ]
  4. Change from Day 1 in CPT score [ Time Frame: Baseline to Week 12 ]
  5. Change from Day 1 in Model for End Stage Liver Disease (MELD) score [ Time Frame: Baseline to Week 12 ]
  6. Absolute HCV RNA [ Time Frame: Baseline to Week 12 ]
  7. Change from Day 1 in HCV RNA [ Time Frame: Baseline to Week 12 ]
  8. Proportion of Participants with Virologic Failure [ Time Frame: Posttreatment Week 12 ]

    Virologic failure is defined as:

    • On-treatment virologic failure:

      • 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)
    • Virologic relapse:

      • Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit



Information from the National Library of Medicine

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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:

  • A body mass index (BMI) of ≥ 18 kg/m^2
  • Chronic HCV infection (≥ 6 months) as documented by either prior medical history or liver biopsy
  • Quantifiable HCV RNA at screening
  • Individuals may be non-transplanted or with recurrent HCV post-liver transplant.

    • If listed for liver transplant, then the projected date of transplant must be ≥12 weeks after Day1 of treatment
    • If post-liver transplant, then Day1 must be ≥ 6 months from date of transplant
  • CPT score of 10 to 12, inclusive, as determined at screening
  • Liver imaging within 6 months of Day 1 to exclude hepatocellular carcinoma (HCC)
  • If treatment-experienced, the most recent HCV treatment must have been completed at least 8 weeks prior to Screening
  • Females of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test on Day 1 prior to randomization
  • Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
  • Females must agree to refrain from egg donation and in vitro fertilization during treatment until at least 30 days after the last dose of SOF/VEL or 6 months after the last dose of RBV, whichever occurs last
  • Lactating females must agree to discontinue nursing before the study drugs are administered
  • Males must agree to refrain from sperm donation from the date of screening until at least 7 months after the last dose of RBV or 30 days after the last dose of SOF/VEL, whichever occurs last
  • 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 medical or psychiatric illness or individual is currently under evaluation for a potentially clinically significant illness
    • Gastrointestinal disorder or post-operative condition that could interfere with the absorption of the study drug
    • Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy
    • Significant pulmonary disease, significant cardiac disease or porphyria
    • Malignancy within the 5 years prior to screening, with the exception of specific cancers that have been cured by surgical resection (basal cell skin cancer, etc.). Adults under evaluation for possible malignancy are not eligible
    • Significant drug allergy (such as anaphylaxis or hepatotoxicity)
  • Any history of organ transplant other than liver or kidney
  • Chronic liver disease of a non-HCV etiology
  • Inability to exclude HCC by imaging within 6 months of Day 1
  • Alpha-fetoprotein (AFP) > 50 unless negative imaging for hepatic masses within the last 6 months or during screening
  • Active spontaneous bacterial peritonitis at screening
  • Infection requiring systemic antibiotics at the time of screening
  • Evidence of fibrosing cholestatic hepatitis at screening
  • Life threatening serious adverse event (SAE) during screening
  • Active variceal bleeding within 6 months of screening
  • Prior placement of a portosystemic shunt (such as TIPS)
  • ECG with clinically significant abnormalities
  • Laboratory parameters with clinically significant abnormalities
  • Hepatitis B surface antigen positive at screening
  • Infection with human immunodeficiency virus (HIV)
  • Clinically-relevant alcohol or drug abuse within 12 months of screening. A positive drug screen will exclude individuals unless it can be explained by a prescribed medication; the diagnosis and prescription must be approved by the Investigator
  • Prior exposure to any HCV Non-structural Protein 5A (NS5A) inhibitor
  • Current use of corticosteroids at any dose >10 mg of prednisone/day (or equivalent dose of corticosteroid)
  • Use of any prohibited concomitant medications
  • Use of granulocyte macrophage colony-stimulating factor (GM-CSF), epoetin alfa or other hematopoietic stimulating agents within 2 weeks of screening
  • Male with pregnant female partner
  • History of clinically significant hemoglobinopathy (eg, sickle cell disease, thalassemia)
  • Contraindications to RBV therapy
  • Known hypersensitivity to VEL, RBV, SOF, the metabolites, or formulation excipients
  • Participation in a clinical study with an investigational drug or biologic within 3 months prior to Day 1

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): NCT02994056


Locations
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United States, Florida
Tampa General Medical Group
Tampa, Florida, United States, 33606
United States, Illinois
Northwestern Memorial Hospital; Clinical Research Unit
Chicago, Illinois, United States, 60611
United States, Maryland
Digestive Disease Associates, PA
Catonsville, Maryland, United States, 21228
United States, Mississippi
Southern Therapy and Advanced Research LLC
Jackson, Mississippi, United States, 39216
United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
American Research Corporation at Texas Liver Institute
San Antonio, Texas, United States, 78215
United States, Utah
Intermountain Liver Disease and Transplant Center
Murray, Utah, United States, 84107
United States, Virginia
Bon Secours St. Mary's Hospital of Richmond, Inc. d/b/a Bon Secours Liver Institute of Virginia
Richmond, Virginia, United States, 23226
United States, Washington
University of Washington/ Harborview Medical Center
Seattle, Washington, United States, 98105
France
Hopital Henri Mondor
Créteil, France, 94010
Hopital Paul Brousse
Villejuif, France, 94800
Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences

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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02994056     History of Changes
Other Study ID Numbers: GS-US-342-4022
2016-003066-10 ( EudraCT Number )
First Posted: December 15, 2016    Key Record Dates
Last Update Posted: December 20, 2018
Last Verified: December 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

Additional relevant MeSH terms:
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Sofosbuvir
Velpatasvir
Sofosbuvir-velpatasvir drug combination
Infection
Hepatitis C
Virus Diseases
Hepatitis, Viral, Human
Flaviviridae Infections
RNA Virus Infections
Hepatitis
Liver Diseases
Digestive System Diseases
Antiviral Agents
Anti-Infective Agents