Intravenous Immunoglobulin for Acute Exacerbation of Idiopathic Pulmonary Fibrosis

JRCT ID: jRCT1061220010

Registered date:25/04/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: idiopathic pulmonary fibrosis
• Date of first enrollment: 17/08/2022
• Target sample size: 24
• Study type: Interventional
• Intervention(s): 5 g/day of intravenous human immunoglobulin for 3 consecutive days.

Outcome(s)

• Primary Outcome: survival proportion on day 90 (confirmed cases by central review)

Secondary Outcome

(1) Identification of prognostic factors
(2) safety
(3) survival proportion on day 90 (all cases)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Patients diagnosed with acute exacerbation of IPF
(2) Patients whose consent for participation in this study can be obtained personally or through his/her legal representative
(3) Patients who are 20 years old or older at the time of obtaining consent.

Exclude criteria

(1) Patients considered to have acute exacerbation of interstitial pneumonia other than IPF (IIPs other than IPF, collagen vascular disease-associated ILD, etc.)
(2) Patients who cannot give consent for the use of blood products
(3) Patients who are denied the coexistence of infectious diseases and do not receive antibiotics
(4) Patients who have a history of acute exacerbation of IPF
(5) Patients judged unsuitable to participate in this clinical study by the investigator

Related Information

• Primary Sponsor: Miyahara Nobuaki