Pediatric Patients Aged 1 to 6 Years With APDS

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

August 30, 2023

Primary Completion Date

April 9, 2025

Study Completion Date

February 28, 2026

Conditions
APDS
Interventions
DRUG

Leniolisib

The doses selected will range from 10 to 50 mg twice daily (BID) (resulting in total daily doses ranging from 20 to 100 mg per day).

Trial Locations (9)

20814

National Institutes of Health, Bethesda

41013

Hospital Universitario Virgen del Rocío, Seville

44122

Rainbow Childrens Hospital, Shaker Heights

77030

Texas Children's Hospital, Houston

90095

University of California Los Angeles, Los Angeles

606-8507

Kyoto University Hospital, Kyoto

113-8519

Institute of Science Tokyo Hospital, Tokyo

3000-075

Hospital Pediátrico de Coimbra da ULS Coimbra UNIDADE LOCAL DE SAÚDE DE COIMBRA, Coimbra

WC1N3JH

Great Ormond Street Hospital, London

Sponsors
All Listed Sponsors
collaborator

CMIC Co, Ltd. Japan

INDUSTRY

collaborator

Labcorp Central Laboratory

UNKNOWN

collaborator

Fortrea

INDUSTRY

collaborator

Aixial Group

INDUSTRY

lead

Pharming Technologies B.V.

INDUSTRY

NCT05693129 - Pediatric Patients Aged 1 to 6 Years With APDS | Biotech Hunter | Biotech Hunter