NCT00795197

A Screening Study Evaluating Disease Status of Gaucher Type I Patients

A Screening Protocol to Characterize the Disease Status of Gaucher Type 1 Patients for Potential Inclusion in a Subsequent Phase 3 Clinical Study

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: 16 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

A screening study to identify and characterize the disease status of patients with Gaucher Type 1 disease for potential inclusion in a subsequent phase 3 clinical study.

Detailed description

The primary objective of this screening study is to identify and characterize the disease status of patients with Gaucher Type 1 disease for potential inclusion in a subsequent Phase 3 clinical study which will evaluate the efficacy and safety of Genz-112638. This will be a multi-center, multi-national screening study to assess the disease status of patients with Gaucher Type 1 disease utilizing criteria to be eligible for enrollment in a subsequent phase 3 clinical study. The assessment performed in this study are standard of care for the evaluation of symptoms of Gaucher Type 1 disease. No study drug will be administered in this screening study.

Conditions

• Gaucher Disease, Type 1

Timeline

• Start date: 2008-12-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2008-11-21
• Last updated: 2015-05-08

Locations

3 sites across 2 countries: United States, India