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NCT02216084 · ClinicalTrials.gov registry record · Phase 1
Phase 1 Dose Escalation, Single Dose Study to Assess Safety and Pharmacokinetics of BAX930 in Hereditary Thrombotic Thrombocytopenic Purpura (TTP)
A Phase 1 study, sponsored by Baxalta now part of Shire.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT02216084 is a Phase 1 study that has completed, run by Baxalta now part of Shire. The registered enrollment target is 16 participants.
The verdict
NCT02216084, a Phase 1 study, has completed, sponsored by Baxalta now part of Shire.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
The purpose of this Phase 1, prospective, uncontrolled, open-label, multicenter, dose-escalation study is to evaluate the safety, including immunogenicity, and pharmacokinetics of BAX930 (rADAMTS13) in a total of 14 evaluable subjects diagnosed with severe hereditary thrombotic thrombocytopenic purpura (TTP) (plasma ADAMTS13 activity \<6%) who are assigned to one of three dose cohorts.
Interventions
- DRUG Recombinant ADAMTS13
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2014-09-30 |
| Est. Completion | 2016-02-22 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02216084
The ClinicalTrials.gov registry entry for NCT02216084 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baxalta now part of Shire, which has 74 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Recombinant ADAMTS13 is the first listed.
NCT02216084 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02216084 about?
NCT02216084 is a clinical study titled "Phase 1 Dose Escalation, Single Dose Study to Assess Safety and Pharmacokinetics of BAX930 in Hereditary Thrombotic Thrombocytopenic Purpura (TTP)". The purpose of this Phase 1, prospective, uncontrolled, open-label, multicenter, dose-escalation study is to evaluate the safety, including immunogenicity, and pharmacokinetics of BAX930 (rADAMTS13) in a total of 14 evaluable subjects diagnosed with severe hereditary thrombotic thrombocytopenic purp...
What is the current status of trial NCT02216084?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2014-09-30. Estimated completion is 2016-02-22.
What interventions are being tested in trial NCT02216084?
The interventions under investigation include: Recombinant ADAMTS13 (DRUG).
Who is sponsoring clinical trial NCT02216084?
This trial is sponsored by Baxalta now part of Shire, which has 74 total clinical trials registered on ClinicalTrials.gov.
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