CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 6 enrolled
Drug / intervention
Agalsidase betadrug
Likely dose
Agalsidase beta (dose not specified in provided text)AI-extracted
Key inclusion· 5
  • ✓Definitively diagnosed cardiac Fabry disease with documented α-GAL activity ≤20% of normal (males) or family history (heterozygous females)
  • ✓Left ventricular hypertrophy documented on cardiac imaging
  • ✓GL-3 accumulation in myocardium or genetic α-GAL deficiency confirmed
  • ✓Interventricular and posterior wall thickness ≥13 mm on echocardiography within 3 months of consent
Key exclusion· 9
  • ✕Severe hypertension (SBP ≥180 mmHg and/or DBP ≥110 mmHg despite adequate medication)
  • ✕Serum creatinine above upper normal limit within 3 months prior to consent
  • ✕History of kidney transplantation or current dialysis
  • ✕Serious hepatic disorder or abnormal liver function (ALT or AST >5× upper normal limit) within 3 months

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

Search/NCT00140621
NCT00140621Phase 4Completed
CompareCT.gov

A Multicenter Open-label Study of the Safety and Efficacy of α-galactosidase A (R-h α-GAL) Replacement Therapy in Patients With Cardiac Fabry Disease

Genzyme, a Sanofi Company·interventional·Posted Sep 1, 2005·Updated May 12, 2015

In Brief

A Phase 4 clinical trial evaluating Agalsidase beta for Fabry Disease. Completed, enrolled 6 participants across 7 sites.

Detailed Summary

This is a multi-center, open label, phase IV study conducted to evaluate the efficacy and safety of agalsidase beta (Fabrazyme \[recombinant form\]) administered by intravenous drip infusion in participants with cardiac Fabry disease. Participants participated for 4 weeks or less in the baseline period and 156 weeks for the treatment period.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFabry Disease
CountriesJapan
Collaborators--

Timeline

Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 1, 2005
Enrollment StartJul 1, 2005
Primary CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 7.1 yearsPosted 20.8 years ago

Interventions

Agalsidase betadrug