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Pharmacokinetics, Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX) Fixed Dose Combination (FDC) in Adolescents and Children 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: NCT03820258
Recruitment Status : Terminated (SOF/VEL/VOX will not be evaluated in younger age groups.)
First Posted : January 29, 2019
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Tracking Information
First Submitted Date  ICMJE January 14, 2019
First Posted Date  ICMJE January 29, 2019
Last Update Posted Date March 24, 2020
Actual Study Start Date  ICMJE January 28, 2019
Actual Primary Completion Date December 4, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2019)
Pharmacokinetic (PK) Parameter: AUCtau of SOF, its Major Metabolite (GS-331007), VEL and VOX. [ Time Frame: Cohorts 1 and 2 (6 to < 18 years of age): predose, 0.5, 1, 2, 3, 4, 6, 8, and 12 hours postdose at Week 2 or 4; Cohort 3 (3 to < 6 years of age): predose, 0.5, 1, 2, 3, 4, 8, and 12 hours postdose at Week 2 or 4 ]
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2019)
  • Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event [ Time Frame: Up to End of Treatment (Week 8 or Week 12) plus 30 days ]
  • 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.
  • Proportion of Participants With HCV RNA < LLOQ 4 Weeks After Discontinuation of Therapy (SVR4) [ Time Frame: Posttreatment Week 4 ]
    SVR4 is defined as HCV RNA < the LLOQ at 4 weeks after stopping study treatment.
  • Proportion of Participants With HCV RNA < LLOQ 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.
  • Proportion of Participants With Overall Virologic Failure [ Time Frame: Up to Posttreatment Week 24 ]
    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.
  • Proportion of Participants With HCV RNA < LLOQ On Treatment [ Time Frame: Up to End of Treatment (Week 8 or Week 12) ]
  • Proportion of Participants Who Develop Resistance to SOF, VEL, and/or VOX During Treatment [ Time Frame: Up to End of Treatment (Week 8 or Week 12) ]
  • Proportion of Participants Who Develop Resistance to SOF, VEL, and/or VOX When Treatment is Discontinued [ Time Frame: Up to Posttreatment Week 24 ]
  • Change in HCV RNA From Day 1 [ Time Frame: Day 1 and up to End of Treatment (Week 8 or Week 12) ]
  • Growth and Development as Measured by Height Percentiles [ Time Frame: Up to Posttreatment Week 24 ]
  • Growth and Development as Measured by Weight Percentiles [ Time Frame: Up to Posttreatment Week 24 ]
  • Growth and Development as Measured by Tanner Stage Assessment [ Time Frame: Up to Posttreatment Week 24 ]
  • Growth and Development as Measured by Radiographic Bone Age Assessment [ Time Frame: Up to End of Treatment (Week 8 or Week 12) ]
  • Growth and Development as Measured by C-Type Collagen Sequence (CTX) Bone Turn-Over Biochemical Marker [ Time Frame: Up to Posttreatment Week 24 ]
  • Growth and Development as Measured by Procollagen Type 1 N-Terminal Propeptide (P1NP) Bone Turn-Over Biochemical Marker [ Time Frame: Up to Posttreatment Week 24 ]
  • Swallowability of SOF/VEL/VOX Tablets as Assessed by the Participant's Ability to Swallow the Solid Dosage Tablet Formulation [ Time Frame: Up to End of Treatment (Week 8 or Week 12) ]
  • Acceptability of SOF/VEL/VOX Tablets as Measured by a Questionnaire to Assess Acceptability, Including Palatability [ Time Frame: Up to End of Treatment (Week 8 or Week 12) ]
  • Neuropsychiatric Assessments as Measured by PedsQL™ Pediatric Quality of Life survey [ Time Frame: Up to Posttreatment Week 24 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetics, Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX) Fixed Dose Combination (FDC) in Adolescents and Children With Chronic Hepatitis C Virus (HCV) Infection
Official Title  ICMJE A Phase 2, Open-Label, Multicenter, Multi-cohort Study to Investigate the Pharmacokinetics, Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed Dose Combination in Adolescents and Children With Chronic HCV Infection
Brief Summary The primary objective of this study is to evaluate the steady-state pharmacokinetics (PK) and confirm the age-appropriate dose of sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC) in pediatric participants with chronic hepatitis C virus (HCV) infection.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hepatitis C Virus Infection
Intervention  ICMJE Drug: SOF/VEL/VOX
Administered once daily with food.
Other Name: Vosevi ®
Study Arms  ICMJE
  • Experimental: Experimental: Cohort 1 (12 to < 18 years old), 8 Weeks
    Direct-acting antiviral (DAA)-naive participants without cirrhosis in Cohort 1 (12 to < 18 years old) will receive SOF/VEL/VOX FDC (400/100/100 mg or a lower dose smaller tablet based on swallowability assessment) for 8 weeks.
    Intervention: Drug: SOF/VEL/VOX
  • Experimental: Experimental: Cohort 1 (12 to < 18 years old), 12 Weeks
    DAA-naive participants with cirrhosis or DAA-experienced participants with or without cirrhosis in Cohort 1 (12 to < 18 years old) will receive SOF/VEL/VOX FDC (400/100/100 mg or a lower dose smaller tablet based on swallowability assessment) for 12 weeks.
    Intervention: Drug: SOF/VEL/VOX
  • Experimental: Experimental: Cohort 2 (6 to < 12 years old), 8 Weeks
    DAA-naive participants without cirrhosis in Cohort 2 (6 to < 12 years old) will receive SOF/VEL/VOX FDC (400/100/100 mg or a lower dose smaller tablet based on swallowability assessment) for 8 weeks.
    Intervention: Drug: SOF/VEL/VOX
  • Experimental: Experimental: Cohort 2 (6 to < 12 years old), 12 Weeks
    DAA-naive participants with cirrhosis or DAA-experienced participants with or without cirrhosis in Cohort 2 (6 to < 12 years old) will receive SOF/VEL/VOX FDC (400/100/100 mg or lower dose smaller tablet based on swallowability assessment) for 12 weeks.
    Intervention: Drug: SOF/VEL/VOX
  • Experimental: Experimental: Cohort 3 (3 to < 6 years old), 8 Weeks
    DAA-naive participants without cirrhosis in Cohort 3 (6 to < 12 years old) will receive SOF/VEL/VOX FDC (a lower dose smaller tablet or a non-tablet formulation based on swallowability assessment) for 8 weeks.
    Intervention: Drug: SOF/VEL/VOX
  • Experimental: Experimental: Cohort 3 (3 to < 6 years old), 12 Weeks
    DAA-naive participants with cirrhosis or DAA-experienced participants with or without cirrhosis in Cohort 3 (3 to < 6 years old) will receive SOF/VEL/VOX FDC (a lower dose smaller tablet or a non-tablet formulation based on swallowability assessment) for 12 weeks.
    Intervention: Drug: SOF/VEL/VOX
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 1, 2019)
21
Original Estimated Enrollment  ICMJE
 (submitted: January 25, 2019)
60
Actual Study Completion Date  ICMJE February 19, 2020
Actual Primary Completion Date December 4, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Consent of parent or legal guardian required
  • Chronic HCV infection
  • Screening laboratory values within defined thresholds
  • Individuals must have a determination of prior treatment status:

    • DAA-naive is defined as either:

      • Treatment naive with no prior exposure to any interferon (IFN), ribavirin (RBV), or approved or experimental HCV-specific DAA
      • Treatment experienced with an IFN-based regimen and no prior exposure to an approved or experimental HCV-specific DAA
    • DAA-experienced is defined as prior exposure to a regimen including any DAA (eg, non-structural protein (NS)3/4A protease inhibitor, NS5A inhibitor, or NS5B nucleotide/nucleoside inhibitor)

Key Exclusion Criteria:

  • History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
  • Co-infection with human immunodeficiency virus (HIV), acute hepatitis A virus (HAV) or hepatitis B virus (HBV)
  • Clinical hepatic decompensation (eg, clinical ascites, encephalopathy, and/or variceal hemorrhage)
  • Pregnant or nursing females
  • Known hypersensitivity to study medication
  • Use of any prohibited concomitant medications as within 28 days of the Day 1 visit

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy,   Poland,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03820258
Other Study ID Numbers  ICMJE GS-US-367-1175
2018-000480-87 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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 https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: 18 months after study completion
Access Criteria: A secured external environment with username, password, and RSA code.
URL: https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy
Responsible Party Gilead Sciences
Study Sponsor  ICMJE Gilead Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Gilead Study Director Gilead Sciences
PRS Account Gilead Sciences
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP