CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 8 enrolled
Drug / intervention
ISU302drug
Likely dose
ISU302 60 U/kg intravenouslyAI-extracted
Key inclusion· 4
  • ✓Confirmed Type 1 Gaucher disease with documented glucocerebrosidase deficiency
  • ✓GD-related anemia (hemoglobin at least 1 g/dL below normal for age/gender)
  • ✓At least one of: moderate splenomegaly (2-3 cm below left costal margin), thrombocytopenia (<90×10⁹/L), or hepatomegaly
  • ✓No prior GD-directed therapy (investigational products, miglustat, velaglucerase alfa, imiglucerase) within 12 months
Key exclusion· 9
  • ✕Type 2 or Type 3 Gaucher disease
  • ✕History of splenectomy
  • ✕Positive for anti-ISU302 or anti-imiglucerase antibodies, or history of anaphylaxis to either agent
  • ✕Any non-GD investigational drug or device within 30 days

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02770625
NCT02770625Phase 3Completed
CompareCT.gov

A Multicenter, Open-Label Phase III Study to Evaluate the Safety and Efficacy of ISU302 (Imiglucerase for Injection) in Patients With Type 1 Gaucher Disease

ISU Abxis Co., Ltd.·interventional·Posted May 12, 2016·Updated Jul 12, 2017

In Brief

A Phase 3 clinical trial evaluating ISU302 for Gaucher Disease, Type 1. Completed, enrolled 8 participants.

Detailed Summary

The purpose of this study is to evaluate the safety and efficacy of ISU302 in patients with Type 1 Gaucher disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGaucher Disease, Type 1
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 12, 2016
Enrollment StartSep 1, 2011
Primary CompletionMar 1, 2013
Study CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 10.1 years ago

Interventions

ISU302drug

60 U/kg given intravenously