Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06406153
Status:
COMPLETED
Last Update Posted:
2024-05-09
First Post:
2024-04-27
Brief Title:
Efficacy and Safety of YW17 Laronidase-CinnaGen Compared to Aldurazyme in MPS I Patients
Sponsor:
Cinnagen
Organization:
Cinnagen
Study Overview
Official Title:
A Phase III Single Arm Cross-over Multicenter Clinical Trial to Compare Efficacy and Safety of YW17Laronidase CinnaGen Versus Laronidase Aldurazyme Genzyme BioMarin in Patients With Mucopolysaccharidosis Type I MPS I
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this phase III study is to assess the efficacy and safety of YW17 produced by CinnaGen Company compared to Aldurazyme in mucopolysaccharidosis type I MPS I patients
All patients receive Aldurazyme for 12 weeks followed by YW17 for another 12 weeks
The primary outcome is the assessment of the maintenance of the mean uGAG levels at the end of each medication administration The secondary outcomes are the assessment of 6-minute walking test 6MWT predicted forced vital capacity FVC enzyme activity assay and adverse events AEs
All patients receive Aldurazyme for 12 weeks followed by YW17 for another 12 weeks
The primary outcome is the assessment of the maintenance of the mean uGAG levels at the end of each medication administration The secondary outcomes are the assessment of 6-minute walking test 6MWT predicted forced vital capacity FVC enzyme activity assay and adverse events AEs
Detailed Description:
This is a phase III single-sequence cross-over study to assess the efficacy and safety of YW17 produced by CinnaGen Company in comparison with Aldurazyme in MPS I patients
All patients receive 058 mgkg of Aldurazyme for 12 weeks and then receive 058 mgkg of YW17 for another 12 weeks
Premedication with antipyretics andor antihistamines is administered for all patients one hour before the infusion
The primary outcome is to compare the mean uGAG levels at weeks 8 10 and 12 related to Aldurazyme with the mean uGAG levels at weeks 20 22 and 24 related to YW17
The secondary outcomes including 6MWT and FVC are assessed at the beginning and the end of each medication administration Enzyme activity is assessed at the end of each medication administration Safety assessments are performed during the study
All patients receive 058 mgkg of Aldurazyme for 12 weeks and then receive 058 mgkg of YW17 for another 12 weeks
Premedication with antipyretics andor antihistamines is administered for all patients one hour before the infusion
The primary outcome is to compare the mean uGAG levels at weeks 8 10 and 12 related to Aldurazyme with the mean uGAG levels at weeks 20 22 and 24 related to YW17
The secondary outcomes including 6MWT and FVC are assessed at the beginning and the end of each medication administration Enzyme activity is assessed at the end of each medication administration Safety assessments are performed during the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None