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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02739165
• Other study ID #: ART-123-AEIPF-301
• Status: Completed
• Phase: Phase 3
• Start date: May 2016
• Est. completion date: December 2018

Study information

• Verified date: July 2017
• Source: Asahi Kasei Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Interstitial Pneumonias
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Drug:
• ART-123
380 U/kg/day by intravenous drip infusion in addition to standard of care steroid therapy
• Placebo
Placebo by intravenous drip infusion in addition to standard of care steroid therapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Asahi Kasei Pharma Corporation

Country where clinical trial is conducted

Japan, 

Outcome

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