Phase I/II Multicenter, Open-label Trial to Evaluate the Safety and Pharmacokinetics of Alpha-1 MP in Patients with Alpha1-Antitrypsin Deficiency

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223105

Enrollment

Registered

2016-02-17

Start date

2016-02-17

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Alpha1-antitrypsin deficiency

Interventions

investigational material(s) Generic name etc : Alpha-1 MP INN of investigational material : Therapeutic category code : 229 Other agents affecting respiratory organs Dosage and Administration for Inv

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Main inclusion criteria: - Subjects with clinically apparent pulmonary emphysema diagnosed by CT scan - Subjects with serum alpha1-PI levels of <50 mg/dL - Subjects whose percentage of force expired volume in 1 second/Forced vital capacity (FEV1/FVC) after inhalation of a bronchodilator is <70 %

Exclusion criteria

Exclusion criteria: Main exclusion criteria: - Subjects with moderately or severely deteriorated lung function within 4 weeks - Subjects whose percentage of forced expired volume in 1 second (%FEV1) after inhalation of a bronchodilator is <30% - Subjects who have undergone lung transplantation or liver transplantation

Design outcomes

Primary

Measure	Time frame
Safety	—

Secondary

Measure	Time frame
Pharmacokinetics	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026