CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 38 enrolled
Drug / intervention
alpha-1 proteinase inhibitor (human)drug
Likely dose
Alpha-1 proteinase inhibitor (human) 60 mg/kg intravenously weekly for 20 weeksAI-extracted
Key inclusion· 2
  • ✓Documented diagnosis of congenital alpha-1-antitrypsin deficiency
  • ✓FEV1 between 20–80% of predicted value (within last 6 months)
Key exclusion· 3
  • ✕Pregnancy, breastfeeding, or inadequate contraception if of childbearing potential
  • ✕Systemic steroids within 2 weeks prior to study treatment (inhaled steroids allowed)
  • ✕Disease exacerbations within 1 month of trial entry

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

Search/NCT00301366
NCT00301366Phase 3Completed
CompareCT.gov

Multi-center, Open-label Trial to Evaluate the Safety and Tolerability of Alpha-1 MP in Subjects With Alpha-1-antitrypsin (AAT) Deficiency

Grifols Therapeutics LLC·interventional·Posted Mar 10, 2006·Updated Aug 19, 2014

In Brief

A Phase 3 clinical trial evaluating alpha-1 proteinase inhibitor (human) for Alpha 1-Antitrypsin Deficiency. Completed, enrolled 38 participants across 10 sites in 2 countries.

Detailed Summary

The purpose of this clinical study is to assess the safety and tolerability of Alpha-1 MP in adult Alpha1-antitrypsin deficient patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlpha 1-Antitrypsin Deficiency
CountriesUnited Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 10, 2006
Enrollment StartJun 1, 2006
Primary CompletionMar 1, 2007
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 20.3 years ago

Interventions

alpha-1 proteinase inhibitor (human)drug

60 mg/kg weekly for 20 weeks