Use of Tirosint®-SOL or Tablet Formulations of Levothyroxine in Pediatric Patients With Congenital Hypothyroidism (CH)

PHASE4TerminatedINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

January 21, 2022

Primary Completion Date

March 27, 2025

Study Completion Date

March 27, 2025

Conditions
Congenital Hypothyroidism
Interventions
DRUG

Tirosint®-SOL

Dosage will be according to the USPI and Standard of Care.

DRUG

Levothyroxine Sodium

Tablets will be crushed and dissolved in solution. Dosage will be according to the USPI and Standard of Care.

Trial Locations (10)

30329

Children's Hospital of Atlanta, Atlanta

45229

Children's Hospital Medical Center, Cincinnati

60611

Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago

64111

Children's Mercy Hospital and Clinics, Kansas City

76104

Cook Children's Health Care Systems, Fort Worth

90027

Children's Hospital of Los Angeles, Los Angeles

92868

CHOC Children's Hospital, Orange

94143

University of California San Francisco, San Francisco

06511

Yale University, New Haven

02115

Boston Children's Hospital, Boston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Cromsource

INDUSTRY

lead

IBSA Institut Biochimique SA

INDUSTRY

NCT05228184 - Use of Tirosint®-SOL or Tablet Formulations of Levothyroxine in Pediatric Patients With Congenital Hypothyroidism (CH) | Biotech Hunter | Biotech Hunter