Clinical Trials Logo
  1. Home
  2. Gaucher's Disease
  3. NCT04656600

Study to Evaluate Efficacy and Safety of Imiglucerase Treatment in Chinese Patients With Gaucher Disease Type Ⅲ — SEED  

Gaucher's Disease Clinical Trial

Official title:
A Single Arm, Prospective, Open Label, Multicenter Study to Evaluate Efficacy and Safety of One-year Maximum Dosage in Chinese Label of Imiglucerase Treatment in Chinese Patients Who Are Diagnosed as Gaucher Disease Type Ⅲ

Clinical Trial Summary

Primary Objective - To evaluate the efficacy on hematologic manifestations of imiglucerase treatment in Chinese patients who are diagnosed as Gaucher disease type Ⅲ - To evaluate the safety profile of imiglucerase in maximum dose in the label (60U/kg, IV biweekly) in Chinese patients. Secondary Objective - To evaluate the efficacy on viscera manifestations of imiglucerase treatment in Chinese patients who are diagnosed as Gaucher disease type Ⅲ - To evaluate the efficacy on bone disease of imiglucerase treatment in Chinese patients who are diagnosed as Gaucher disease type Ⅲ - To evaluate the effect on quality of life of imiglucerase treatment in Chinese patients who are diagnosed as Gaucher disease type Ⅲ

Clinical Trial Description

Approximatively 14 months including a 12 months treatment period ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04656600
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 4
Start date March 2, 2021
Completion date October 12, 2023
View Details
See also
  Status Clinical Trial Phase
Completed NCT00001289 - Effects of Enzyme Replacement in Gaucher's Disease N/A
Completed NCT00004488 - Phase II Randomized Study of Alendronate Sodium for Osteopenia in Patients With Gaucher's Disease Phase 2
Completed NCT00001410 - PEG-Glucocerebrosidase for the Treatment of Gaucher Disease Phase 1
Recruiting NCT00004293 - Phase II Study of Glucocerebrosidase in Patients With Gaucher Disease Phase 2
Completed NCT00004294 - Phase I Study of Retrovirally Mediated Transfer of the Human Glucocerebrosidase Gene Into Peripheral Blood Stem Cells for Autologous Transplantation in Patients With Type I Gaucher Disease Phase 1
Completed NCT01427517 - Intravenous N-acetylcysteine for the Treatment of Gaucher's Disease and Parkinson's Disease Phase 1
Completed NCT00176904 - Stem Cell Transplant for Inborn Errors of Metabolism Phase 2/Phase 3
Completed NCT00001234 - Gene Therapy for Gaucher's and Fabry Disease Using Viruses and Blood-Forming Cells Phase 1
Completed NCT06188325 - A Study to Evaluate Pharmacokinetic Parameters of Eliglustat in Healthy Volunteers Who Are CYP2D6 Extensive or Poor Metabolizers Phase 1
Completed NCT00001416 - Bone Response to Enzyme Replacement in Gaucher's Disease Phase 2
Completed NCT06193304 - A Study to Evaluate Pharmacokinetic Parameters and Safety of Eliglustat Absorption Through the Mouth Phase 1
Active, not recruiting NCT00005900 - Study of Pulmonary Complications in Pediatric Patients With Storage Disorders Undergoing Allogeneic Hematopoietic Stem Cell Transplantation N/A
Completed NCT01586455 - Human Placental-Derived Stem Cell Transplantation Phase 1