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Trial record 1 of 1 for:    NCT03022981
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Sofosbuvir/Velpatasvir in Adolescents and Children With Chronic HCV Infection

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ClinicalTrials.gov Identifier: NCT03022981
Recruitment Status : Recruiting
First Posted : January 18, 2017
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Tracking Information
First Submitted Date  ICMJE January 13, 2017
First Posted Date  ICMJE January 18, 2017
Last Update Posted Date June 5, 2019
Actual Study Start Date  ICMJE January 26, 2017
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 13, 2017)
  • For the PK Lead-in Phase, PK Parameter: AUCtau of Velpatasvir (VEL), Sofosbuvir (SOF), and its Metabolite GS-331007 [ Time Frame: Predose and up to 12 hours postdose ]
    AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
  • For the Treatment Phase, Percentage of Participants Experiencing Any Treatment-Emergent Adverse Event (AE) with a Focus on AEs Leading to Discontinuation of Study Drug [ Time Frame: Up to 12 weeks plus 30 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03022981 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 13, 2017)
  • For the PK Lead-in Phase, HCV RNA from Baseline Through Day 7 [ Time Frame: Up to 7 days ]
  • For the PK Lead-in Phase, Any Adverse Event Leading to Permanent Discontinuation of Study Drug [ Time Frame: Up to 7 days ]
  • For the Treatment Phase, 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.
  • For the Treatment Phase, Proportion of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) [ Time Frame: Posttreatment Week 4 ]
    SVR4 is defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.
  • For the Treatment Phase, Proportion of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24) [ Time Frame: Posttreatment Week 24 ]
    SVR 24 is defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.
  • For the Treatment Phase, Proportion of Participants With 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.
  • For the Treatment Phase, Proportion of Participants With HCV RNA < LLOQ On Treatment [ Time Frame: Up to 12 weeks ]
  • For the Treatment Phase, Emergence of Viral Resistance to SOF and/or VEL During Treatment and When Treatment is Discontinued [ Time Frame: Up to Posttreatment Week 24 ]
  • For the Treatment Phase, HCV RNA Change from Baseline [ Time Frame: Baseline and up to 12 weeks ]
  • For the Treatment Phase, Quality of Life as Measured by PedsQL™ Pediatric Quality of Life Survey [ Time Frame: Up to Posttreatment Week 24 ]
  • For the Treatment Phase, Growth and Development as Measured by Height [ Time Frame: Up to Posttreatment Week 24 ]
  • For the Treatment Phase, Growth and Development as Measured by Weight [ Time Frame: Up to Posttreatment Week 24 ]
  • For the Treatment Phase, Growth and Development as Measured by by Tanner Stage Assessment [ Time Frame: Up to Posttreatment Week 24 ]
  • For the Treatment Phase, Growth and Development as Measured by Parental Height [ Time Frame: Day 1 ]
  • For the Treatment Phase, Growth and Development as Measured by Bone Age [ Time Frame: Up to Posttreatment Week 24 ]
  • For the Treatment Phase, Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Swallowability and Palatability at Day 1 [ Time Frame: Day 1 ]
  • For the Treatment Phase, Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Swallowability and Palatability at Week 12 [ Time Frame: Week 12 ]
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 Sofosbuvir/Velpatasvir in Adolescents and Children With Chronic HCV Infection
Official Title  ICMJE A Phase 2, Open-Label, Multicenter, Multi-cohort Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir in Adolescents and Children With Chronic HCV Infection
Brief Summary

This study will have 2 parts: Pharmacokinetics (PK) Lead-in Phase and the Treatment Phase.

The primary objective of the PK Lead-in Phase is to evaluate the steady state PK and confirm the dose of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) in pediatric participants with chronic hepatitis C virus (HCV) infection.

The primary objective of the Treatment Phase is to evaluate the safety and tolerability of SOF/VEL for 12 weeks in pediatric participants with chronic HCV.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hepatitis C Virus Infection
Intervention  ICMJE Drug: SOF/VEL
FDC tablet or oral granules administered once daily
Other Names:
  • Epclusa®
  • GS-7977/GS-5816
Study Arms  ICMJE
  • Experimental: PK Lead-in Phase: Cohort 1 (12 to < 18 years old)
    SOF/VEL FDC (1 x 400/100 mg tablet or 2 x 200/50 mg tablets) for 7 days
    Intervention: Drug: SOF/VEL
  • Experimental: PK Lead-in Phase: Cohort 2 (6 to < 12 years old)
    Pending PK and safety results from Cohort 1, participants in Cohort 2 will initiate and receive SOF/VEL FDC (age-appropriate dose) for 7 days.
    Intervention: Drug: SOF/VEL
  • Experimental: PK Lead-in Phase: Cohort 3 (3 to < 6 years old)

    3 to < 6 years of age: SOF/VEL FDC 200/50 mg oral granules (4 x 50/12.5 mg packets) administered once daily, for participants who weigh ≥17 kg;

    SOF/VEL FDC 150/37.5 mg oral granules (3 x 50/12.5 mg packets) administered once daily, for participants who weigh < 17 kg

    Intervention: Drug: SOF/VEL
  • Experimental: Treatment Phase: Group 1 (12 to < 18 years old)
    Participants from the PK Lead-in will immediately rollover into Treatment Phase with no interruption of study drug administration until the appropriateness of the dose has been confirmed by PK and safety results from the PK Lead-in. Additional participants (12 to < 18 years of age) will be enrolled in the Treatment Phase upon confirmation of the appropriateness of the dose from the PK Lead-in Phase and will receive SOF/VEL FDC for 12 weeks.
    Intervention: Drug: SOF/VEL
  • Experimental: Treatment Phase: Group 2 (3 to < 12 years old)
    Participants from the PK Lead-in will immediately rollover into Treatment Phase with no interruption of study drug administration until the appropriateness of the dose has been confirmed by PK and safety results from the PK Lead-in. Additional participants (3 to < 12 years of age) will be enrolled in the Treatment Phase upon confirmation of the appropriateness of the dose from the PK Lead-in Phase and will receive SOF/VEL FDC for 12 weeks.
    Intervention: Drug: SOF/VEL
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 13, 2017)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2020
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Chronic HCV-infected, treatment-naive and treatment-experienced adolescent and pediatric individuals aged 3 to < 18 as determined at Day 1.

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: Gilead Clinical Study Information Center 1-833-445-3230 (GILEAD-0) GileadClinicalTrials@gilead.com
Listed Location Countries  ICMJE Belgium,   Italy,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03022981
Other Study ID Numbers  ICMJE GS-US-342-1143
2016-002446-23 ( 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
IPD Sharing Statement  ICMJE Not Provided
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 June 2019

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