Long-term safety study by A1-PI

A multi-center, open-label study to evaluate the long-term safety of weekly intravenous infusions of alpha1-proteinase inhibitor (human) in Japanese subjects with alpha1 antitrypsin deficiency (AATD)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223139

Enrollment

Registered

2016-03-09

Start date

2016-10-14

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

AATD

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 In

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Main inclusion criteria: Subjects who complete participation in another study (JapicCTI-No.163160)

Exclusion criteria

Exclusion criteria: Main exclusion criteria: Subjects who are not enrolled in JapicCTI-No.163160

Design outcomes

Primary

Measure	Time frame
safety Long-term Safety	—

Secondary

Measure	Time frame
safety Long-term safety	—

Countries

Japan

Outcome results

None listed

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