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NCT00701701 · ClinicalTrials.gov registry record · Phase 4
Immune Tolerance Induction Study
A Phase 4 study, sponsored by Genzyme, a Sanofi Company.
- Terminated
- Registry status
- Phase 4
- Development phase
- 4
- Enrollment target
NCT00701701 is a Phase 4 study that was terminated before completion, run by Genzyme, a Sanofi Company. The registered enrollment target is 4 participants.
The verdict
NCT00701701, a Phase 4 study, was terminated before completion, sponsored by Genzyme, a Sanofi Company.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 4 participants
- Enrollment target
Study Summary
An exploratory, open-labeled study of participants with Pompe disease, who had previously received Myozyme® (alglucosidase alfa) treatment, to evaluate the efficacy, safety and clinical benefit of 2 Immune Tolerance Induction (ITI) regimens in combination with Myozyme®. Eligible participants who were then receiving Myozyme® therapy were enrolled into the study, and were followed for a minimum of 18 months on-study (a 6-month ITI treatment module and a 12-month follow-up module on Myozyme® alone). Eligible participants were followed for a minimum of 18 months on treatment or, if a participant was \<6 months of age at the time of enrollment, until the participant was 2 years of age. Both cross-reacting immunologic material (CRIM)-negative and CRIM-positive participants were eligible for Regimen A depending if they met the required criteria. Regimen B, however, was limited to CRIM-negative participants.
Interventions
- BIOLOGICAL Myozyme® (alglucosidase alfa)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2008-12-14 |
| Est. Completion | 2020-02-18 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00701701
The ClinicalTrials.gov registry entry for NCT00701701 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genzyme, a Sanofi Company, which has 196 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Myozyme® (alglucosidase alfa) is the first listed.
NCT00701701 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00701701 about?
NCT00701701 is a clinical study titled "Immune Tolerance Induction Study". An exploratory, open-labeled study of participants with Pompe disease, who had previously received Myozyme® (alglucosidase alfa) treatment, to evaluate the efficacy, safety and clinical benefit of 2 Immune Tolerance Induction (ITI) regimens in combination with Myozyme®. Eligible participants who wer...
What is the current status of trial NCT00701701?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 4 participants. The study started on 2008-12-14. Estimated completion is 2020-02-18.
What interventions are being tested in trial NCT00701701?
The interventions under investigation include: Myozyme® (alglucosidase alfa) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00701701?
This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.
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