Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir in Adolescents and Children With Chronic HCV Infection
Hepatitis C Virus Infection
About this trial
This is an interventional treatment trial for Hepatitis C Virus Infection
Eligibility 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.
Sites / Locations
- Children's Hospital Los Angeles
- University of California, San Francisco
- Children's Hospital of Colorado
- Children's National Medical Center
- University of Florida Shands Medical
- Florida Gastroenterology Care for Children
- Emory Children's Center
- Riley Hospital for Children
- Kosair Charities Pediatric Clinical Research Unit
- Johns Hopkins University (JHU) - The Johns Hopkins Hospital (JHH)
- Boston Children's Hospital
- Children's Mercy Hospital
- Children's Hospital & Medical Center
- Mount Sinai Medical Center
- Cincinnati Children's Hospital Medical Center
- Nationwide Children's Hospital- The Ohio State University (OSU)
- The Children's Hospital of Philadelphia
- Monroe Carell Jr. Children's Hospital at Vanderbilt
- Cook Children's Medical Center
- Baylor College of Medicine
- Seattle Children's Hospital
- Cliniques Universitaires Saint Luc
- Azienda Ospedaliero-Universitaria di Bologna - Policlinico S. Orsola - Malpighi
- Azienda Ospedaliera Universitaria Meyer
- Ospedale Casa Sollievo della Sofferenza
- The Leeds Teaching Hospitals NHS Trust
- King's College Hospital NHS Trust
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
12 to < 18 Years Old
6 to < 12 Years Old
3 to < 6 Years Old
PK Lead-in Phase: Sofosbuvir/Velpatasvir (SOF/VEL) 400/100 mg once daily for 7 days. Participants who complete the PK lead-in phase, continue into the treatment phase with no interruption of study drug administration and additional participants will be enrolled into the treatment phase once the appropriateness of the dose is confirmed by PK results from the PK lead-in phase. Treatment Phase: SOF/VEL 400/100 mg once daily for 12 weeks.
PK Lead-in Phase: SOF/VEL 200/50 mg once daily for 7 days. Participants who complete the PK lead-in phase, continue into the treatment phase with no interruption of study drug administration and additional participants will be enrolled into the treatment phase once the appropriateness of the dose is confirmed by PK results from the PK lead-in phase. Treatment Phase: SOF/VEL 200/50 mg once daily for 12 weeks.
PK Lead-in Phase: SOF/VEL 200/50 mg once daily for 7 days for participants who weigh ≥ 17 kg. SOF/VEL 150/37.5 mg once daily for 7 days for participants who weigh < 17 kg. Participants who complete the PK lead-in phase, continue into the treatment phase with no interruption of study drug administration and additional participants will be enrolled into the treatment phase once the appropriateness of the dose is confirmed by PK results from the PK lead-in phase. Treatment Phase: SOF/VEL 200/50 mg once daily for 12 weeks for participants who weigh ≥ 17 kg. SOF/VEL 150/37.5 mg once daily for 12 weeks for participants who weigh < 17 kg.