Idiopathic Pulmonary Fibrosis Clinical Trial
Official title:
Phase III Clinical Study of ART-123 for the Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosis: a Multicenter Randomized Placebo-controlled Double-blind Study to Assess the Efficacy and Safety of ART-123
Verified date | July 2017 |
Source | Asahi Kasei Pharma Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 74 |
Est. completion date | December 2018 |
Est. primary completion date | September 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 85 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Asahi Kasei Pharma Corporation |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Chest imaging findings (chest HRCT findings) | Within 90days | ||
Other | Blood gas test | Within 90days | ||
Other | mMRC | Within 90days | ||
Other | CAT | Within 90days | ||
Other | Dyspnea-12 | Within 90days | ||
Other | Duration of respiration management | Within 90days | ||
Other | Inflammatory markers | Within 90days | ||
Other | Interstitial pneumonia markers | Within 90days | ||
Other | Total duration of respiratory system-related inpatient hospitalization | Within 90days | ||
Other | Adverse events (AEs) | Within 90days | ||
Other | AEs related to hemorrhage | Within 90days | ||
Other | Routine laboratory tests | Within 90days | ||
Other | Vital signs | Within 90days | ||
Other | Presence of anti-drug antibodies | Within 90days | ||
Primary | Survival rate on Day 90 | 90 days | ||
Secondary | Overall survival | 180 days after the start of investigational product administration in the last subject | ||
Secondary | Survival time up to Day 90 | 90days | ||
Secondary | P/F ratio | 4 days, 7 days, 15 days, 28 days, 60 days, 90 days | ||
Secondary | Coagulation tests | 4 days, 7 days, 15days, 28 days, 60 days, 90 days |
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