CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 4 enrolled
Drug / intervention
Alpha-1 MPbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02870309
NCT02870309Phase 2Completed
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Phase I/II Multicenter, Open-label Trial to Evaluate the Safety and Pharmacokinetics of Alpha-1 MP in Patients With Alpha1-Antitrypsin Deficiency

Grifols Therapeutics LLC·interventional·Posted Aug 17, 2016·Updated Oct 28, 2021

In Brief

A Phase 2 clinical trial evaluating Alpha-1 MP for Alpha1-Antitrypsin Deficiency. Completed, enrolled 4 participants across 2 sites.

Detailed Summary

This study is a multicenter, open-label trial to evaluate the safety and pharmacokinetics of weekly intravenous infusions of 60 mg/kg of Alpha-1 MP (alpha1-proteinase inhibitor (human), modified process) for 8 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlpha1-Antitrypsin Deficiency
CountriesJapan
CollaboratorsGrifols Japan K.K.

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedAug 17, 2016
Enrollment StartJul 29, 2016
Primary CompletionMar 15, 2017
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 9.9 years ago

Interventions

Alpha-1 MPbiological

Alpha-1 MP is a stable, sterile, lyophilized preparation of human alpha1-PI, also known as α1-antitrypsin