to evaluate a triple therapy: plasma exchange, rituximab, intravenous immunoglobulin (IVIg) and corticosteroid administration compared to standard corticosteroid therapy in patients for severe acute exacerbation of idiopathic pulmonary

Phase 1

• Conditions: severe acute exacerbation of idiopathic pulmonary fibrosis; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2018-002632-24-FR
• Lead Sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-20
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

1.Patient = 18 years of age and < 75 years
2.Admitted to ICU in the last 72 h
3.Definite or probable IPF diagnosis defined on 2011 ATS/ERS/JRS/ALAT guidelines or a possible usual interstitial pneumonia pattern on HRCT without etiology.
4.Definite AE-IPF according to the 2016 revised criteria :
a) Previous or concurrent diagnosis of idiopathic pulmonary fibrosis (if the diagnosis of IPF is not previously established, this criterion can be met by the presence of radiologic and or histopathologic changes consistent with usual interstitial pneumonia (UIP) pattern on the current evaluation);
b) Acute worsening or development of dyspnea typically of less than one-month duration;
c) Computed tomography with new bilateral ground-glass opacity and/or consolidation superimposed on a background pattern consistent with a UIP pattern (if no previous computed tomography is available, the qualifier new” can be dropped);
d) Deterioration not fully explained by cardiac failure or fluid overload.
5.PaO2/FiO2 ratio < 200

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Known hypersensitivity intravenous immunoglobulins or rituximab
2.Severe heart failure
3.Active and uncontrolled bacterial fungal or parasitic infection
4.Positive multiplex PCR for Influenzae A and B, and for VRS
5.Deep Veinous Thrombosis or Pulmonary embolism in the last six months
6.Prior exposures to human-murine chimeric antibodies
7.Ongoing treatment with a cellular immunosuppressant (e.g., cyclophosphamide, methotrexate, mycophenolate, azathioprine, calcineurin inhibitors, etc.)
8.Subject treated with more than 2 boluses of methylprednisolone (total dose > 500mg of methylprednisolone) or one dose > 10mg/kg in the last 72 hours
9.Uncorrectable coagulopathies or thrombocytopenia < 30000/mm3
10.Active cancer (other than basal cell carcinoma of the skin)
11.Other source of immunosuppression (i.e. HIV infection, solid organ transplant, lymphoma or leukemia)
12.Pregnancy
13.Patient listed for lung transplantation
14.Patient on ECMO
15.Patient with a do-not-intubate order at admission to ICU
16.Concurrent participation in other experimental trials
17.Not Affiliation to the French social security
18.Not Written informed consent from the patient or a legal representative if appropriate

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified