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NCT00069641 · ClinicalTrials.gov registry record · Phase 2

Iduronate-2-sulfatase Enzyme Replacement Therapy in Mucopolysaccharidosis II (MPS II)

A Phase 2 study, sponsored by Shire.

Completed
Registry status
Phase 2
Development phase
96
Enrollment target

NCT00069641 is a Phase 2 study that has completed, run by Shire. The registered enrollment target is 96 participants.

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The verdict

NCT00069641, a Phase 2 study, has completed, sponsored by Shire.

COMPLETED
Registry status
Phase 2
Development phase
96 participants
Enrollment target

Study Summary

The purpose of this study is to determine whether the administration of iduronate-2-sulfatase enzyme in a weekly or every other week therapy frequency is safe and efficacious in patients with MPS II.

Interventions

  • BIOLOGICAL Placebo
  • BIOLOGICAL Iduronate-2-sulfatase enzyme replacement therapy
  • BIOLOGICAL iduronate-2-sulfatase enzyme replacement therapy

Trial Details

FieldValue
Enrollment Target 96 participants
Start Date 2003-09-18
Est. Completion 2005-03-16
Phase Phase 2

Sponsor

Shire

245 total trials

What the Registry Record Tells You About NCT00069641

The ClinicalTrials.gov registry entry for NCT00069641 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 96 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shire, which has 245 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT00069641 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00069641 about?

NCT00069641 is a clinical study titled "Iduronate-2-sulfatase Enzyme Replacement Therapy in Mucopolysaccharidosis II (MPS II)". The purpose of this study is to determine whether the administration of iduronate-2-sulfatase enzyme in a weekly or every other week therapy frequency is safe and efficacious in patients with MPS II.

What is the current status of trial NCT00069641?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 96 participants. The study started on 2003-09-18. Estimated completion is 2005-03-16.

What interventions are being tested in trial NCT00069641?

The interventions under investigation include: Placebo (BIOLOGICAL), Iduronate-2-sulfatase enzyme replacement therapy (BIOLOGICAL), iduronate-2-sulfatase enzyme replacement therapy (BIOLOGICAL).

Who is sponsoring clinical trial NCT00069641?

This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.