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

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 40 Years - 85 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02739165
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Asahi Kasei Pharma Corporation
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Asahi Kasei Pharma Corporation
Principal Investigator Affiliation Asahi Kasei Pharma Corporation
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Japan
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Idiopathic Pulmonary Fibrosis

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Ogaki, Gifu, Japan

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Recruiting

Address

Ogaki, Gifu,

Himeji, Hyogo, Japan

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Recruiting

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Himeji, Hyogo,

Kobe, Hyogo, Japan

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Recruiting

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Kobe, Hyogo,

Naka, Ibaragi, Japan

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Recruiting

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Naka, Ibaragi,

Yokohama, Kanagawa, Japan

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Recruiting

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Yokohama, Kanagawa,

Sendai, Miyagi, Japan

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Recruiting

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Sendai, Miyagi,

Tenri, Nara, Japan

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Recruiting

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Tenri, Nara,

Kurashiki, Okanaya, Japan

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Recruiting

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Kurashiki, Okanaya,

Osakasayama, Osaka, Japan

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Recruiting

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Osakasayama, Osaka,

Sakai, Osaka, Japan

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Recruiting

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Sakai, Osaka,

Hamamatsu, Shizuoka, Japan

Status

Recruiting

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Hamamatsu, Shizuoka,

Shimotsuke, Tochigi, Japan

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Recruiting

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Shimotsuke, Tochigi,

Bunkyo, Tokyo, Japan

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Recruiting

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Bunkyo, Tokyo,

Minato, Tokyo, Japan

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Recruiting

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Minato, Tokyo,

Ota, Tokyo, Japan

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Recruiting

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Ota, Tokyo,

Shibuya, Tokyo, Japan

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Recruiting

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Shibuya, Tokyo,

Sinjyuku, Tokyo, Japan

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Recruiting

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Sinjyuku, Tokyo,

Kurume, Fukuoka, Japan

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Recruiting

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Kurume, Fukuoka,

Nagoya, Aichi, Japan

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Recruiting

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Nagoya, Aichi,

Seto, Aichi, Japan

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Recruiting

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Seto, Aichi,

Kamogawa, Chiba, Japan

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Recruiting

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Kamogawa, Chiba,

Sakura, Chiba, Japan

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Recruiting

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Sakura, Chiba,

Chiba, Japan

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Recruiting

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Chiba, ,

Fukuoka, Japan

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Recruiting

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Fukuoka, ,

Kumamoto, Japan

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Recruiting

Address

Kumamoto, ,

Nagasaki, Japan

Status

Recruiting

Address

Nagasaki, ,