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NCT02412787 · ClinicalTrials.gov registry record · Phase 2

Study of Long Term Safety and Clinical Outcomes of Idursulfase IT and Elaprase Treatment in Pediatric Participants Who Have Completed Study HGT-HIT-094

A Phase 2 study, sponsored by Shire.

Completed
Registry status
Phase 2
Development phase
56
Enrollment target

NCT02412787 is a Phase 2 study that has completed, run by Shire. The registered enrollment target is 56 participants.

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The verdict

NCT02412787, a Phase 2 study, has completed, sponsored by Shire.

COMPLETED
Registry status
Phase 2
Development phase
56 participants
Enrollment target

Study Summary

This extension study will allow participants that completed Study HGT-HIT-094 to continue receiving Elaprase treatment in conjunction with idursulfase IT or to continue receiving Elaprase treatment and begin concurrent IT treatment for those that did not receive idursulfase IT treatment in Study HGT-HIT-094.

Interventions

  • DRUG Idursulfase-IT
  • DRUG Elaprase

Trial Details

FieldValue
Enrollment Target 56 participants
Start Date 2015-04-14
Est. Completion 2024-04-18
Phase Phase 2

Sponsor

Shire

245 total trials

What the Registry Record Tells You About NCT02412787

The ClinicalTrials.gov registry entry for NCT02412787 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 56 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 2 interventions - of which Idursulfase-IT is the first listed.

NCT02412787 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02412787 about?

NCT02412787 is a clinical study titled "Study of Long Term Safety and Clinical Outcomes of Idursulfase IT and Elaprase Treatment in Pediatric Participants Who Have Completed Study HGT-HIT-094". This extension study will allow participants that completed Study HGT-HIT-094 to continue receiving Elaprase treatment in conjunction with idursulfase IT or to continue receiving Elaprase treatment and begin concurrent IT treatment for those that did not receive idursulfase IT treatment in Study HGT...

What is the current status of trial NCT02412787?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 56 participants. The study started on 2015-04-14. Estimated completion is 2024-04-18.

What interventions are being tested in trial NCT02412787?

The interventions under investigation include: Idursulfase-IT (DRUG), Elaprase (DRUG).

Who is sponsoring clinical trial NCT02412787?

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.