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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 : October 8, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

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.


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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : January 26, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Sofosbuvir

Arm Intervention/treatment
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
Drug: SOF/VEL
FDC tablet or oral granules administered once daily
Other Names:
  • Epclusa®
  • GS-7977/GS-5816

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.
Drug: SOF/VEL
FDC tablet or oral granules administered once daily
Other Names:
  • Epclusa®
  • GS-7977/GS-5816

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

Drug: SOF/VEL
FDC tablet or oral granules administered once daily
Other Names:
  • Epclusa®
  • GS-7977/GS-5816

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.
Drug: SOF/VEL
FDC tablet or oral granules administered once daily
Other Names:
  • Epclusa®
  • GS-7977/GS-5816

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.
Drug: SOF/VEL
FDC tablet or oral granules administered once daily
Other Names:
  • Epclusa®
  • GS-7977/GS-5816




Primary Outcome Measures :
  1. 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).

  2. 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 ]

Secondary Outcome Measures :
  1. For the PK Lead-in Phase, HCV RNA from Baseline Through Day 7 [ Time Frame: Up to 7 days ]
  2. For the PK Lead-in Phase, Any Adverse Event Leading to Permanent Discontinuation of Study Drug [ Time Frame: Up to 7 days ]
  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. For the Treatment Phase, Proportion of Participants With HCV RNA < LLOQ On Treatment [ Time Frame: Up to 12 weeks ]
  8. 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 ]
  9. For the Treatment Phase, HCV RNA Change from Baseline [ Time Frame: Baseline and up to 12 weeks ]
  10. For the Treatment Phase, Quality of Life as Measured by PedsQL™ Pediatric Quality of Life Survey [ Time Frame: Up to Posttreatment Week 24 ]
  11. For the Treatment Phase, Growth and Development as Measured by Height [ Time Frame: Up to Posttreatment Week 24 ]
  12. For the Treatment Phase, Growth and Development as Measured by Weight [ Time Frame: Up to Posttreatment Week 24 ]
  13. For the Treatment Phase, Growth and Development as Measured by by Tanner Stage Assessment [ Time Frame: Up to Posttreatment Week 24 ]
  14. For the Treatment Phase, Growth and Development as Measured by Parental Height [ Time Frame: Day 1 ]
  15. For the Treatment Phase, Growth and Development as Measured by Bone Age [ Time Frame: Up to Posttreatment Week 24 ]
  16. 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 ]
  17. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


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): NCT03022981


Contacts
Contact: Gilead Clinical Study Information Center 1-833-445-3230 (GILEAD-0) GileadClinicalTrials@gilead.com

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Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Gilead Study Director Gilead Sciences

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT03022981     History of Changes
Other Study ID Numbers: GS-US-342-1143
2016-002446-23 ( EudraCT Number )
First Posted: January 18, 2017    Key Record Dates
Last Update Posted: October 8, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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
Sofosbuvir
Sofosbuvir-velpatasvir drug combination
Antiviral Agents
Anti-Infective Agents