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Trial record 1 of 1 for:    NCT02739165
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Clinical Study of ART-123 for the Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosis

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ClinicalTrials.gov Identifier: NCT02739165
Recruitment Status : Completed
First Posted : April 15, 2016
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
Asahi Kasei Pharma Corporation

Tracking Information
First Submitted Date  ICMJE April 1, 2016
First Posted Date  ICMJE April 15, 2016
Last Update Posted Date January 18, 2019
Study Start Date  ICMJE May 2016
Actual Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 11, 2016)
Survival rate on Day 90 [ Time Frame: 90 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2016)
  • Overall survival [ Time Frame: 180 days after the start of investigational product administration in the last subject ]
  • Survival time up to Day 90 [ Time Frame: 90days ]
  • P/F ratio [ Time Frame: 4 days, 7 days, 15 days, 28 days, 60 days, 90 days ]
  • Coagulation tests [ Time Frame: 4 days, 7 days, 15days, 28 days, 60 days, 90 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 11, 2016)
  • Chest imaging findings (chest HRCT findings) [ Time Frame: Within 90days ]
  • Blood gas test [ Time Frame: Within 90days ]
  • mMRC [ Time Frame: Within 90days ]
  • CAT [ Time Frame: Within 90days ]
  • Dyspnea-12 [ Time Frame: Within 90days ]
  • Duration of respiration management [ Time Frame: Within 90days ]
  • Inflammatory markers [ Time Frame: Within 90days ]
  • Interstitial pneumonia markers [ Time Frame: Within 90days ]
  • Total duration of respiratory system-related inpatient hospitalization [ Time Frame: Within 90days ]
  • Adverse events (AEs) [ Time Frame: Within 90days ]
  • AEs related to hemorrhage [ Time Frame: Within 90days ]
  • Routine laboratory tests [ Time Frame: Within 90days ]
  • Vital signs [ Time Frame: Within 90days ]
  • Presence of anti-drug antibodies [ Time Frame: Within 90days ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Clinical Study of ART-123 for the Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosis
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Idiopathic Pulmonary Fibrosis
Intervention  ICMJE
  • Drug: ART-123
    380 U/kg/day by intravenous drip infusion in addition to standard of care steroid therapy
  • Drug: Placebo
    Placebo by intravenous drip infusion in addition to standard of care steroid therapy
Study Arms  ICMJE
  • Experimental: ART-123
    Intervention: Drug: ART-123
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 11, 2016)
74
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2018
Actual Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02739165
Other Study ID Numbers  ICMJE ART-123-AEIPF-301
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Asahi Kasei Pharma Corporation
Study Sponsor  ICMJE Asahi Kasei Pharma Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Asahi Kasei Pharma Corporation Asahi Kasei Pharma Corporation
PRS Account Asahi Kasei Pharma Corporation
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP