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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: Completed Phase 1 study, sponsored by Baxalta now part of Shire.

NCT02216084 is a Phase 1 study that has completed, run by Baxalta now part of Shire. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 16 participants
Start Date 2014-09-30
Est. Completion 2016-02-22
Phase Phase 1
Baxalta now part of Shire

74 total trials

What the finished NCT02216084 record still lists

NCT02216084 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).

The record links to 0 conditions, and to 1 intervention - of which Recombinant ADAMTS13 is the first listed.

NCT02216084 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT02216084's enrollment target sits among peer trials

16 1786th of 2000 higher than 203 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02216084, the US trial registry maintained by the National Library of Medicine. NCT02216084 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.