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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by Asahi Kasei Pharma Corporation
Sponsor:
Information provided by (Responsible Party):
Asahi Kasei Pharma Corporation
ClinicalTrials.gov Identifier:
NCT02739165
First received: April 1, 2016
Last updated: June 17, 2016
Last verified: June 2016
  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.

Condition Intervention Phase
Idiopathic Pulmonary Fibrosis
Drug: ART-123
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Asahi Kasei Pharma Corporation:

Primary Outcome Measures:
  • Survival rate on Day 90 [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: 180 days after the start of investigational product administration in the last subject ] [ Designated as safety issue: No ]
  • Survival time up to Day 90 [ Time Frame: 90days ] [ Designated as safety issue: No ]
  • P/F ratio [ Time Frame: 4 days, 7 days, 15 days, 28 days, 60 days, 90 days ] [ Designated as safety issue: No ]
  • Coagulation tests [ Time Frame: 4 days, 7 days, 15days, 28 days, 60 days, 90 days ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Chest imaging findings (chest HRCT findings) [ Time Frame: Within 90days ] [ Designated as safety issue: No ]
  • Blood gas test [ Time Frame: Within 90days ] [ Designated as safety issue: No ]
  • mMRC [ Time Frame: Within 90days ] [ Designated as safety issue: No ]
  • CAT [ Time Frame: Within 90days ] [ Designated as safety issue: No ]
  • Dyspnea-12 [ Time Frame: Within 90days ] [ Designated as safety issue: No ]
  • Duration of respiration management [ Time Frame: Within 90days ] [ Designated as safety issue: No ]
  • Inflammatory markers [ Time Frame: Within 90days ] [ Designated as safety issue: No ]
  • Interstitial pneumonia markers [ Time Frame: Within 90days ] [ Designated as safety issue: No ]
  • Total duration of respiratory system-related inpatient hospitalization [ Time Frame: Within 90days ] [ Designated as safety issue: No ]
  • Adverse events (AEs) [ Time Frame: Within 90days ] [ Designated as safety issue: Yes ]
  • AEs related to hemorrhage [ Time Frame: Within 90days ] [ Designated as safety issue: Yes ]
  • Routine laboratory tests [ Time Frame: Within 90days ] [ Designated as safety issue: Yes ]
  • Vital signs [ Time Frame: Within 90days ] [ Designated as safety issue: Yes ]
  • Presence of anti-drug antibodies [ Time Frame: Within 90days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 74
Study Start Date: May 2016
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ART-123 Drug: ART-123
380 U/kg/day by intravenous drip infusion in addition to standard of care steroid therapy
Placebo Comparator: Placebo Drug: Placebo
Placebo by intravenous drip infusion in addition to standard of care steroid therapy

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 50,000/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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02739165

Contacts
Contact: Asahi Kasei Pharma Corporation ct-info@om.asahi-kasei.co.jp

Locations
Japan
Recruiting
Seto, Aichi, Japan
Recruiting
Sakura, Chiba, Japan
Recruiting
Kurume, Fukuoka, Japan
Recruiting
Ogaki, Gifu, Japan
Recruiting
Himeji, Hyogo, Japan
Recruiting
Kobe, Hyogo, Japan
Not yet recruiting
Naka, Ibaragi, Japan
Recruiting
Yokohama, Kanagawa, Japan
Recruiting
Tenri, Nara, Japan
Not yet recruiting
Kurashiki, Okanaya, Japan
Not yet recruiting
Oosakasayama, Oosaka, Japan
Recruiting
Sakai, Osaka, Japan
Recruiting
Hamamatu, Shizuoka, Japan
Recruiting
Bunkyo, Tokyo, Japan
Not yet recruiting
Minato, Tokyo, Japan
Recruiting
Minato, Tokyo, Japan
Recruiting
Ota, Tokyo, Japan
Not yet recruiting
Shibuya, Tokyo, Japan
Not yet recruiting
Sinjyuku, Tokyo, Japan
Recruiting
Chiba, Japan
Recruiting
Fukuoka, Japan
Recruiting
Kumamoto, Japan
Recruiting
Nagasaki, Japan
Sponsors and Collaborators
Asahi Kasei Pharma Corporation
Investigators
Study Chair: Asahi Kasei Pharma Corporation Asahi Kasei Pharma Corporation
  More Information

Responsible Party: Asahi Kasei Pharma Corporation
ClinicalTrials.gov Identifier: NCT02739165     History of Changes
Other Study ID Numbers: ART-123-AEIPF-301 
Study First Received: April 1, 2016
Last Updated: June 17, 2016
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Asahi Kasei Pharma Corporation:
Acute exacerbations
Idiopathic pulmonary fibrosis
Recombinant human soluble thrombomodulin
ART-123

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial

ClinicalTrials.gov processed this record on July 26, 2016