An Open-Label, Multicenter Study to Evaluate the Long-term Safety of Weekly Intravenous Alphal-Proteinase Inhibitor (Human), Modified Process 60 mg/kg 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

CTIS2024-513962-20-00

Acronym

GTi1201_OLE

Enrollment

120

Registered

2024-08-21

Start date

2016-07-14

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 efficacy variables that will be assessed are: •Whole lung 15th percentile point (PD15) using computed tomography (CT) densitometry •Carbon monoxide diffusing capacity (DLCO) •forced expiratory volume in 1 second (FEV1) •St. George’s Respiratory Questionnaire (SGRQ) score •Five level EQ-5D (EQ-5D-5L) score •Incidence and severity of chronic obstructive pulmonary disease (COPD) exacerbations as defined by American Thoracic Society (ATS)/European Respiratory Society (ERS) criteria

Detailed description

The following safety variables will be assessed in this study: •AEs, serious AEs (SAEs), and discontinuations due to AEs and SAEs •Physical examination (complete and respiratory) •Clinical laboratory parameters: hematology, chemistry (includes high-sensitivity C-reactive protein [hs-CRP])

Interventions

DRUGALPHA-1-PROTEINASE INHIBITOR (HUMAN)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The efficacy variables that will be assessed are: •Whole lung 15th percentile point (PD15) using computed tomography (CT) densitometry •Carbon monoxide diffusing capacity (DLCO) •forced expiratory volume in 1 second (FEV1) •St. George’s Respiratory Questionnaire (SGRQ) score •Five level EQ-5D (EQ-5D-5L) score •Incidence and severity of chronic obstructive pulmonary disease (COPD) exacerbations as defined by American Thoracic Society (ATS)/European Respiratory Society (ERS) criteria	—

Measure

Time frame

—

Secondary

Measure	Time frame
The following safety variables will be assessed in this study: •AEs, serious AEs (SAEs), and discontinuations due to AEs and SAEs •Physical examination (complete and respiratory) •Clinical laboratory parameters: hematology, chemistry (includes high-sensitivity C-reactive protein [hs-CRP])	—

Countries

Denmark, Estonia, Finland, France, Poland, Sweden

Outcome results

None listed

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