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Single Arm Open Labeled Multicenter Trial for Safety and Efficacy of recombinant human soluble Thrombomodulin for Acute Exacerbation of Idiopathic Interstitial pneumonias

Single Arm Open Labeled Multicenter Trial for Safety and Efficacy of recombinant human soluble Thrombomodulin for Acute Exacerbation of Idiopathic Interstitial pneumonias - Trial for Safety and Efficacy of Thrombomodulin for Acute Exacerbation of Idiopathic Interstitial Pneumonias (SETUP Trial)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000014969
Enrollment
40
Registered
2014-08-28
Start date
2014-08-28
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute exacerbation of idiopathic interstitial pneumonias

Interventions

Intervention: recombinant soluble human thrombomodulin Control: Cases of acute exacerbation of idiopathic interstitial pneumonias treated in the past

Sponsors

NHO Kinki-Chuo Chest Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Cases of acute exacerbation of chronic idiopathic interstitial pneumonias.

Exclusion criteria

Exclusion criteria: 1) Patients with major organ dysfunction. 2) Patients with fatal bleeding including intracranial bleeding, bleeding from gastrointestinal tracts, lung hemorrhage and so on. 3) Patients with high probability of fatal bleeding. 4) Patients with cerebral vascular diseases within one year. 5) Patients with intracranial damage caused by operations and external injury. 6) Pregnant or lactating woman, and woman with possibility of pregnancy. 7) Patients with apparent infection. 8) Patients within one month after surgery. 9) Patients with past history of hypersensitivity to thrombomodulin. 10) Patients improper to the trial according to the decision of a chief doctor.

Design outcomes

Primary

MeasureTime frame
90 days survival compared with cases of acute exacerbation of idiopathic interstitial pneumonias treated in the past.

Secondary

MeasureTime frame
Changes of serum markers, coagulation markers, arterial blood gas analysis and HRCT findings after the start of thrombomodulin are observed. Occurrence of bleeding and frequency of positive pressure ventilation are compared with control.

Countries

Japan

Contacts

Public ContactToru Arai

NHO Kinki-Chuo Chest Medical Center Clinical Research Center

arai.toru.cp@mail.hosp.go.jp072-252-3021

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026