A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Two Dose Regimens (60 mg/kg and 120 mg/kg) of Weekly Intravenous Alpha1-Proteinase Inhibitor (Human) in Subjects with Pulmonary Emphysema due to Alpha1-Antitrypsin Deficiency

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-510030-83-00

Acronym

GTi1201

Enrollment

170

Registered

2024-08-21

Start date

2014-01-29

Completion date

Unknown

Last updated

2025-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Emphysema due to Alpha-1-Antitrypsin Deficiency

Brief summary

The primary variable to assess efficacy in this study is whole lung PD15 using CT densitometry.

Detailed description

Severe COPD exacerbations as defined by ATS/ERS criteria (i.e., COPD exacerbations that require hospitalization), PD15 of the basal lung region using CT densitometry.

Interventions

DRUGPlacebo to be used in this clinical trial is 0.9% sodium chloride injection

DRUGunited states pharmacopeia (0.9% nacl

DRUGusp) (please refer to section 1.6.3 placebo rationale and 3.3 treatments – 3.3.1.2 placebo in the protocol for a more detailed description).

DRUGALPHA-1-PROTEINASE INHIBITOR (HUMAN)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary variable to assess efficacy in this study is whole lung PD15 using CT densitometry.	—

Secondary

Measure	Time frame
Severe COPD exacerbations as defined by ATS/ERS criteria (i.e., COPD exacerbations that require hospitalization), PD15 of the basal lung region using CT densitometry.	—

Countries

Denmark, Finland, France, Poland, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026