Idiopathic Pulmonary Fibrosis
Conditions
Keywords
Acute exacerbations, Idiopathic pulmonary fibrosis, Recombinant human soluble thrombomodulin, ART-123
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.
Interventions
DRUGART-123
380 U/kg/day by intravenous drip infusion in addition to standard of care steroid therapy
DRUGPlacebo
Placebo by intravenous drip infusion in addition to standard of care steroid therapy
Sponsors
Asahi Kasei Pharma Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival rate on Day 90 | 90 days |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Other
| Measure | Time frame |
|---|---|
| Vital signs | Within 90days |
| Presence of anti-drug antibodies | Within 90days |
| Chest imaging findings (chest HRCT findings) | Within 90days |
| Blood gas test | Within 90days |
| Interstitial pneumonia markers | Within 90days |
| CAT | Within 90days |
| Dyspnea-12 | Within 90days |
| Duration of respiration management | Within 90days |
| Inflammatory markers | Within 90days |
| mMRC | Within 90days |
| Total duration of respiratory system-related inpatient hospitalization | Within 90days |
| Adverse events (AEs) | Within 90days |
| AEs related to hemorrhage | Within 90days |
| Routine laboratory tests | Within 90days |
Countries
Japan
Outcome results
None listed