AzTrials
AzTrials

Idiopathic Pulmonary FibrosisPhase 3NCT02739165

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

A Phase 3 study testing ART-123 in people with Idiopathic Pulmonary Fibrosis, run by Asahi Kasei Therapeutics Corporation at 26 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 40 to 85 years
Conditions the study is for
Idiopathic Pulmonary Fibrosis
What is being tested?
ART-123
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
74 participants
Where
26 sitesJapan
Study dates
May 2016to Dec 2018
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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 locations and contacts

26 sites in 1 country.

26 sites in 1 country

Japan26 sites

  • Study site

    Bunkyo, Tokyo

  • Study site

    Chiba

  • Study site

    Fukuoka

  • Study site

    Hamamatsu, Shizuoka

  • Study site

    Himeji, Hyōgo

  • Study site

    Kamogawa, Chiba

  • Study site

    Kobe, Hyōgo

  • Study site

    Kumamoto

  • Study site

    Kurashiki, Okanaya

  • Study site

    Kurume, Fukuoka

  • Study site

    Minato, Tokyo

  • Study site

    Nagasaki

  • Study site

    Nagoya, Aichi-ken

  • Study site

    Naka, Ibaragi

  • Study site

    Ōgaki, Gifu

  • Study site

    Ōta-ku, Tokyo

  • Study site

    Sakai, Osaka

  • Study site

    Sakura, Chiba

  • Study site

    Sayama, Osaka

  • Study site

    Sendai, Miyagi

  • Study site

    Seto, Aichi-ken

  • Study site

    Shibuya City, Tokyo

  • Study site

    Shimotsuke, Tochigi

  • Study site

    Shinjuku, Tokyo

  • Study site

    Tenri, Nara

  • Study site

    Yokohama, Kanagawa

Other trials in Japan

About this study

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

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.

Being tested
ART-123, Placebo
Keywords
Acute exacerbations, Idiopathic pulmonary fibrosis, Recombinant human soluble thrombomodulin, ART-123
Medical subject headings
Idiopathic Pulmonary Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ART-123Drug

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

  • PlaceboDrug

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

Study groups in NCT02739165
Study groupRoleWhat they receive
ART-123ExperimentalNot described
Receives: Drug: ART-123
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Survival rate on Day 90

    Measured: 90 days

Secondary outcomes (4)

  1. Overall survival

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

  2. Survival time up to Day 90

    Measured: 90days

  3. P/F ratio

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

  4. Coagulation tests

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2016 (estimated)
  2. Study startMay 2016
  3. Primary completionSep 2018
  4. Study completionDec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02739165
Sponsor's protocol ID
ART-123-AEIPF-301
Status last verified
Jul 2017
First submitted
1 Apr 2016
Last updated
18 Jan 2019
Results posted
No

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.

    PubMed 31917621

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ART-123 in people with Idiopathic Pulmonary Fibrosis, run by Asahi Kasei Therapeutics Corporation at 26 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Survival rate on Day 90 (time frame: 90 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02739165, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2019; AzTrials last refreshed its copy on 8 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in