Clinical Trials Logo

Clinical Trial Summary

Phase I/II, open label, multicenter, multinational (Japan, Brazil and the US) extension study of JR-171-101 for the treatment of MPS I


Clinical Trial Description

Patients who have completed the Part2 of JR-171-101 study and fulfill all eligibility criteria can be enrolled in this JR-171-102 study. Until the dose determination in the JR-171-102 study, subjects will intravenously receive either low dose or high dose of JR-171 at the same doses received at Week 12 of the JR-171-101 study. Thereafter, all subjects will be transitioned to the optimal dose determined based on the results of JR-171-101 study. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04453085
Study type Interventional
Source JCR Pharmaceuticals Co., Ltd.
Contact
Status Active, not recruiting
Phase Phase 1/Phase 2
Start date October 28, 2021
Completion date April 30, 2025

See also
  Status Clinical Trial Phase
Terminated NCT01675674 - Study to Detect Unrecognized Mucopolysaccharidosis in Children Visiting Rheumatology, Hand or Skeletal Dysplasia Clinics N/A
Completed NCT00741338 - Immune Tolerance Study With Aldurazyme® (Laronidase) Phase 1/Phase 2
Recruiting NCT05687474 - Baby Detect : Genomic Newborn Screening
Completed NCT04227600 - A Study of JR-171 in Patients With Mucopolysaccharidosis I Phase 1/Phase 2
Completed NCT05134571 - China Post-marketing Surveillance (PMS) Study of Aldurazyme® Phase 4
Terminated NCT00418821 - A Study of the Effect of Aldurazyme® (Laronidase) Treatment on Lactation in Female Patients With Mucopolysaccharidosis I (MPS I) and Their Breastfed Infants Phase 4
Completed NCT03071341 - Extension Study Evaluating Long Term Safety and Activity of AGT-181 in Children With MPS I Phase 1/Phase 2
Completed NCT03053089 - Safety and Dose Ranging Study of Human Insulin Receptor MAb-IDUA Fusion Protein in Adults and Children With MPS I Phase 1/Phase 2
Completed NCT00146757 - A Study Evaluating the Safety and Pharmacokinetics of Aldurazyme® (Laronidase) in MPS I Patients Less Than 5 Years Old Phase 2
Active, not recruiting NCT04628871 - Long Term Follow-up (LTFU) of Subjects Who Received SB-318, SB-913, or SB-FIX
Completed NCT02597114 - Extension Study of AGT-181-102 to Evaluate Long Term Safety and Activity of AGT-181 Phase 1
Terminated NCT00748969 - Clinical Trial of Growth Hormone in MPS I, II, and VI Phase 2/Phase 3
Terminated NCT00215527 - Intrathecal Enzyme Replacement Therapy for Spinal Cord Compression in Mucopolysaccharidosis (MPS) I Phase 1
Recruiting NCT05619900 - Registry of Patients Diagnosed With Lysosomal Storage Diseases
Completed NCT00146770 - Phase 3 Extension Study of the Safety and Efficacy of Aldurazyme® (Laronidase) in Mucopolysaccharidosis I (MPS I) Patients Phase 3
Completed NCT00176917 - Stem Cell Transplantation for Hurler Phase 2
Completed NCT00176891 - Stem Cell Transplant w/Laronidase for Hurler Phase 2
Active, not recruiting NCT03153319 - Study to Evaluate the Safety and Efficacy of Adalimumab in MPS I, II, and VI Phase 1/Phase 2
Completed NCT00852358 - A Study of Intrathecal Enzyme Therapy for Cognitive Decline in MPS I N/A
Enrolling by invitation NCT06103487 - Long Term Follow-Up for RGX-111