Efficacy and Safety of YW17 (Laronidase-CinnaGen) Compared to Aldurazyme® in MPS I Patients

PHASE3CompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

September 10, 2022

Primary Completion Date

August 12, 2023

Study Completion Date

November 18, 2023

Conditions
Mucopolysaccharidosis Type 1
Interventions
BIOLOGICAL

Laronidase

Laronidase as Aldurazyme® (the first 12 weeks) or YW17 (the second 12 weeks) is administered.

DRUG

Antihistamine

An antihistamine is administered one hour before the infusion.

DRUG

Antipyretic

An antipyretic is administered one hour before the infusion.

Trial Locations (4)

Unknown

Clinical Research Development Unit of Akbar Hospital, Faculty of Medicine, Mashhad

Growth and Development Research Center, Childrens Medical Center, Tehran

Loghman Hospital, Tehran

Mofid Childrens Hospital, Tehran

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Cinnagen

INDUSTRY