Clinical Study of ART-123 for the Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosis

Asahi Kasei Medical

Status and phase

Completed

Phase 3

Conditions

Idiopathic Pulmonary Fibrosis

Treatments

Drug: ART-123

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02739165

ART-123-AEIPF-301

Details and patient eligibility

About

The purpose of this study is to assess the efficacy and safety of the intravenous drip infusion of ART-123 in patients with acute exacerbation of idiopathic pulmonary fibrosis (IPF) in a multicenter, double-blind, randomized, placebo-controlled, parallel group comparison study, and to confirm its superiority over placebo with survival rate on Day 90 as the primary endpoint.

Enrollment

74 patients

Sex

All

Ages

40 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria:

Patients diagnosed with IPF who meet all criteria from (1) through (4) during the course of IPF
(1)Unexplained development or worsening of dyspnea within 1 month during the course of IPF
(2)Finding of new, bilateral ground glass opacities and/or consolidation on HRCT
(3)No apparent Pulmonary infections, pneumothorax, malignant tumors, pulmonary embolism, or left heart failure
(4)A decrease* in PaO2 of ≥10 mmHg or SpO2 of ≥4% under the same conditions compared with the level at the previous measurements
- (*) In cases where no PaO2 or SpO2 test values under the same conditions are available, a patient with a P/F ratio ≤300 in the current episode of acute exacerbation is considered to have met criterion (4)
Aged 40 years or older and no older than 85 years at the time of informed consent with either sex

Main Exclusion Criteria:

Have intracranial hemorrhage, pulmonary hemorrhage, gastrointestinal bleeding (continued hematemesis, bloody discharge, gastrointestinal ulcer-induced hemorrhage)
Have a history of cerebrovascular disorder (e.g., cerebral hemorrhage or cerebral infarction) within 52 weeks (364 days) before informed consent
Patients for whom the completion of hemostatic treatment has not been confirmed after undergoing surgery of the central nervous system or after trauma
Have a high risk for fatal or life-threatening hemorrhage
Patients with malignant tumors
Have acute exacerbation attributable to drug induced pulmonary disorder, after surgery for malignant tumors, chemotherapy, or radiation therapy
Have acute exacerbation due to a thoracic surgical procedure (including thoracoscopic lung biopsy)
Have a history of acute exacerbation of IPF
Receiving mechanical ventilation through intratracheal intubation
Patients who are pregnant or nursing, or who may be pregnant
Patients with a platelet count less than 100,000/uL at the time of enrollment
Patients with severe renal (serum Cr: ≥4 mg/dL) or hepatic (AST/ALT: ≥500 IU/L or T-Bil: ≥10 mg/dL) dysfunction
Have been administered a commercially available thrombomodulin alfa (recombinant )(Recomodulin® for Intravenous Injection 12800) within 30 days before the start of investigational product administration
Have a history of hypersensitivity for investigational product