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Long Term Safety of Alpha1-Proteinase Inhibitor in Subjects With Alpha1 Antitrypsin Deficiency

NCT02796937 · Status: ENROLLING_BY_INVITATION · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 290

Last updated 2026-03-04

No results posted yet for this study

Summary

This is a 2-year open-label, multicenter extension of the double-blind, placebo-controlled GTi1201 study. The purpose of this study is to obtain an additional 2 years of safety data for intravenously administered Alpha1-MP 60 mg/kg/week in subjects with alpha1-antitrypsin deficiency (AATD).

Conditions

  • Pulmonary Emphysema in Alpha-1 Antitrypsin Deficiency

Interventions

BIOLOGICAL

Alpha-1 MP

Alpha-1 MP 60 mg/kg/week for up to 104 weeks

Sponsors & Collaborators

  • Grifols Therapeutics LLC

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
72 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2028-09-30
Completion
2029-02-28

Countries

  • United States
  • Australia
  • Canada
  • Denmark
  • Estonia
  • Finland
  • France
  • Moldova
  • New Zealand
  • Poland
  • Russia
  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02796937 on ClinicalTrials.gov