NCT02739165

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2016

Typical duration for phase_3

Geographic Reach
1 country

26 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 15, 2016

Completed
16 days until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

January 18, 2019

Status Verified

July 1, 2017

Enrollment Period

2.3 years

First QC Date

April 1, 2016

Last Update Submit

January 17, 2019

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

Acute exacerbationsIdiopathic pulmonary fibrosisRecombinant human soluble thrombomodulinART-123

Outcome Measures

Primary Outcomes (1)

  • Survival rate on Day 90

    90 days

Secondary Outcomes (4)

  • Overall survival

    180 days after the start of investigational product administration in the last subject

  • Survival time up to Day 90

    90days

  • P/F ratio

    4 days, 7 days, 15 days, 28 days, 60 days, 90 days

  • Coagulation tests

    4 days, 7 days, 15days, 28 days, 60 days, 90 days

Other Outcomes (14)

  • Chest imaging findings (chest HRCT findings)

    Within 90days

  • Blood gas test

    Within 90days

  • mMRC

    Within 90days

  • +11 more other outcomes

Study Arms (2)

ART-123

EXPERIMENTAL
Drug: ART-123

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

ART-123DRUG

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

ART-123
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

Unknown Facility

Nagoya, Aichi-ken, Japan

Location

Unknown Facility

Seto, Aichi-ken, Japan

Location

Unknown Facility

Kamogawa, Chiba, Japan

Location

Unknown Facility

Sakura, Chiba, Japan

Location

Unknown Facility

Kurume, Fukuoka, Japan

Location

Unknown Facility

Ōgaki, Gifu, Japan

Location

Unknown Facility

Himeji, Hyōgo, Japan

Location

Unknown Facility

Kobe, Hyōgo, Japan

Location

Unknown Facility

Naka, Ibaragi, Japan

Location

Unknown Facility

Yokohama, Kanagawa, Japan

Location

Unknown Facility

Sendai, Miyagi, Japan

Location

Unknown Facility

Tenri, Nara, Japan

Location

Unknown Facility

Kurashiki, Okanaya, Japan

Location

Unknown Facility

Sakai, Osaka, Japan

Location

Unknown Facility

Sayama, Osaka, Japan

Location

Unknown Facility

Hamamatsu, Shizuoka, Japan

Location

Unknown Facility

Shimotsuke, Tochigi, Japan

Location

Unknown Facility

Bunkyo, Tokyo, Japan

Location

Unknown Facility

Minato, Tokyo, Japan

Location

Unknown Facility

Ōta-ku, Tokyo, Japan

Location

Unknown Facility

Shibuya City, Tokyo, Japan

Location

Unknown Facility

Shinjuku, Tokyo, Japan

Location

Unknown Facility

Chiba, Japan

Location

Unknown Facility

Fukuoka, Japan

Location

Unknown Facility

Kumamoto, Japan

Location

Unknown Facility

Nagasaki, Japan

Location

Related Publications (1)

  • 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.

    PMID: 31917621DERIVED

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

ART123

Condition Hierarchy (Ancestors)

Pulmonary FibrosisLung Diseases, InterstitialLung DiseasesRespiratory Tract Diseases

Study Officials

  • Asahi Kasei Pharma Corporation

    Asahi Kasei Pharma Corporation

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2016

First Posted

April 15, 2016

Study Start

May 1, 2016

Primary Completion

September 1, 2018

Study Completion

December 1, 2018

Last Updated

January 18, 2019

Record last verified: 2017-07

Locations

JP(26)