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

Conditions

• Pulmonary Emphysema in Alpha-1 Antitrypsin Deficiency

Eligibility Criteria

Sex

ALL

Age

20 Years - 72 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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).

Key Dates

Start date

Jul 31, 2016

Status verified

Mar 2026

Primary completion

Sep 30, 2028

Completion

Feb 28, 2029

Study Design

Enrollment

290 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

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

Primary Outcome Measure

Adverse events (AEs) [ Time Frame: Week 1 through Week 108 ]

Locations (6)

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