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

NCT ID: NCT02739165

Last Updated: 2019-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2018-12-31

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.

Conditions

Idiopathic Pulmonary Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

ART-123

Group Type: EXPERIMENTAL

ART-123

Intervention Type: DRUG

380 U/kg/day by intravenous drip infusion in addition to standard of care steroid therapy

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo by intravenous drip infusion in addition to standard of care steroid therapy

Interventions

ART-123

380 U/kg/day by intravenous drip infusion in addition to standard of care steroid therapy

Intervention Type: DRUG

Placebo

Placebo by intravenous drip infusion in addition to standard of care steroid therapy

Intervention Type: DRUG

Eligibility Criteria

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

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asahi Kasei Pharma Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Asahi Kasei Pharma Corporation

Role: STUDY_CHAIR

Asahi Kasei Pharma Corporation

Locations

Nagoya, Aichi-ken, Japan

Seto, Aichi-ken, Japan

Kamogawa, Chiba, Japan

Sakura, Chiba, Japan

Kurume, Fukuoka, Japan

Ōgaki, Gifu, Japan

Himeji, Hyōgo, Japan

Kobe, Hyōgo, Japan

Naka, Ibaragi, Japan

Yokohama, Kanagawa, Japan

Sendai, Miyagi, Japan

Tenri, Nara, Japan

Kurashiki, Okanaya, Japan

Sakai, Osaka, Japan

Sayama, Osaka, Japan

Hamamatsu, Shizuoka, Japan

Shimotsuke, Tochigi, Japan

Bunkyo, Tokyo, Japan

Minato, Tokyo, Japan

Ōta-ku, Tokyo, Japan

Shibuya City, Tokyo, Japan

Shinjuku, Tokyo, Japan

Chiba, , Japan

Fukuoka, , Japan

Kumamoto, , Japan

Nagasaki, , Japan

Countries

Japan

References

Kondoh Y, Azuma A, Inoue Y, Ogura T, Sakamoto S, Tsushima K, Johkoh T, Fujimoto K, Ichikado K, Matsuzawa Y, Saito T, Kishi K, Tomii K, Sakamoto N, Aoshima M, Araya J, Izumi S, Arita M, Abe M, Yamauchi H, Shindoh J, Suda T, Okamoto M, Ebina M, Yamada Y, Tohda Y, Kawamura T, Taguchi Y, Ishii H, Hashimoto N, Abe S, Taniguchi H, Tagawa J, Bessho K, Yamamori N, Homma S. Thrombomodulin Alfa for Acute Exacerbation of Idiopathic Pulmonary Fibrosis. A Randomized, Double-Blind Placebo-controlled Trial. Am J Respir Crit Care Med. 2020 May 1;201(9):1110-1119. doi: 10.1164/rccm.201909-1818OC.

Reference Type: DERIVED

PMID: 31917621 (View on PubMed)

Other Identifiers

ART-123-AEIPF-301

Identifier Type: -

Identifier Source: org_study_id