Phase III clinical study of ART-123 for the treatment of acute exacerbation of idiopathic pulmonary fibrosis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223271

Enrollment

Registered

2016-07-22

Start date

2016-06-09

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

Acute exacerbation of idiopathic pulmonary fibrosis (AE-IPF)

Interventions

investigational material(s) Generic name etc : ART-123 INN of investigational material : thrombomodulin alfa Therapeutic category code : 333 Anticoagulants Dosage and Administration for Investigationa

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Main Inclusion Criteria Patients diagnosed with AE-IPF

Exclusion criteria

Exclusion criteria: Main Exclusion Criteria [1]Have intracranial hemorrhage, pulmonary hemorrhage, gastrointestinal bleeding (continued hematemesis, bloody discharge, gastrointestinal ulcer-induced hemorrhage) [2]Have a history of cerebrovascular disorder (e.g., cerebral hemorrhage or cerebral infarction) within 52 weeks (364 days) before informed consent [3]Patients who are pregnant or nursing, or who may be pregnant [4]Have a history of hypersensitivity for investigational product

Design outcomes

Primary

Measure	Time frame
efficacy Survival rate on Day 90	—

Secondary

Measure	Time frame
efficacy 1)Overall survival 2)Survival time up to Day 90 3)P/F ratio 4)Coagulation tests	—

Countries

Japan

Outcome results

None listed

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