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Enzyme Replacement Therapy

Arm A: Prospective for Gaucher Disease (SWITCH Trial)

Phase 4
Waitlist Available
Research Sponsored by Takeda
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline up to month 12
Awards & highlights

SWITCH Trial Summary

This trial will provide information on outcomes in people with type 1 Gaucher disease when they are treated with velaglucarase alfa (also called VPRIV), under standard care. Standard care means the participant will be treated according to the clinic's standard practice.

SWITCH Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline up to month 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline up to month 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Clinically Stable Hemoglobin (Hb) Concentration From Baseline up to Month 12
Number of Participants With Clinically Stable Liver Volume From Baseline up to Month 12
Number of Participants With Clinically Stable Platelet Count From Baseline in Platelet Count up to Month 12
+1 more
Secondary outcome measures
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

SWITCH Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm B: RetrospectiveExperimental Treatment1 Intervention
Participants with GD1 transitioning from SRT to ERT (VPRIV) or ERT to SRT and then to ERT (VPRIV) previously (within the past 5 years at the time of enrollment) will be assessed retrospectively after switch to ERT for up to 12 months.
Group II: Arm A: ProspectiveExperimental Treatment1 Intervention
Participants with Gaucher's Disease 1 (GD1) transitioning from SRTs to ERT (VPRIV) or ERT to SRT and then to ERT (VPRIV) in a real-world setting among adults 18 and older will be studied by observing standard patient care and by reviewing the results of tests and assessments that would be performed as part of their routine treatment.

Find a Location

Who is running the clinical trial?

TakedaLead Sponsor
1,202 Previous Clinical Trials
4,178,258 Total Patients Enrolled
8 Trials studying Gaucher Disease
181,313 Patients Enrolled for Gaucher Disease
Study DirectorStudy DirectorTakeda
1,207 Previous Clinical Trials
489,676 Total Patients Enrolled
19 Trials studying Gaucher Disease
12,593 Patients Enrolled for Gaucher Disease

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study of Enzyme Replacement Therapy (VPRIV) in People With Type 1 Gaucher Disease Who Were Previously Treated With Substrate Reduction Therapy
2021. "A Study of Enzyme Replacement Therapy (VPRIV) in People With Type 1 Gaucher Disease Who Were Previously Treated With Substrate Reduction Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04718779.
~1 spots leftby Apr 2025
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