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

Phase 3

Completed

• Conditions: Idiopathic Pulmonary Fibrosis
• Interventions: Drug: ART-123; Drug: Placebo

• Registration Number: NCT02739165
• Lead Sponsor: Asahi Kasei Pharma Corporation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-01
• Study First Submitted QC: 2016-04-11
• Study First Posted: 2016-04-15
• Study Start: 2016-05
• Status Verified: 2017-07
• Primary Completion: 2018-09
• Study Completion: 2018-12
• Last Update Submitted: 2019-01-17
• Last Update Posted: 2019-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ART-123	ART-123	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Survival rate on Day 90	90 days

Secondary Outcome Measures

Name	Time	Method
Overall survival	180 days after the start of investigational product administration in the last subject
Survival time up to Day 90	90days
P/F ratio	4 days, 7 days, 15 days, 28 days, 60 days, 90 days
Coagulation tests	4 days, 7 days, 15days, 28 days, 60 days, 90 days