Idiopathic interstitial pneumonias(GradeIII to IV)
Conditions
Interventions
Intravenous infusion of 40mg of PC-SOD(lecithinized superoxide dismutase) is administered over 1 hour once a day for consecutive 28 days.
Intravenous infusion of 80mg of PC-SOD(lecithinized superoxide
Sponsors
LTT Bio-Pharma Co.,Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients confirmed idiopathic interstitial pneumonias by X-ray and HRCT 2)Patients with Grade III to Grade IV idiopathic interstitial pneumonias and possible measurement of vital capacity 3)Patients must be in hospital during the period of the clinical trial. After the trial, they will be consulted in hospital or as outpatients. 4)Patients who personally give informed consent in writing
Exclusion criteria
Exclusion criteria: 1)Exclusion criteria with respect to relative diseases (1)Patients with interstitial pneumonia caused by medicine (2)Patients who have complicated asthma or COPD (3)Patients who have complicated infectious disease of lung(respiratory organs) which affects the effect of the drug 2)Exclusion criteria with respect to prior treatment (1)Patients who initiated steroid administration or changed the usage and dosage of it within four weeks prior to the investigational new drug (2)Patients who initiated administration of immunosuppressive drugs(ciclosporin, tacrolimus hydrate, azathioprine, cyclophosphamide, methotrexate) 3)Exclusion criteria with respect to safety (1)Patients with disease of kidney, liver, digestive organs(more than middle class) (2)Patients with severe blood disease or circulatory organ disease (3)Patients with the past or complication of neoplasms such as cancers or tumors (4)Patients who are pregnant or have possibility of pregnancy and are under breast-feeding (5)Patients who attended any other clinical trial within four months prior to this trial (6)Patients who have the history of allergic reactions against protein drugs (7)Patients with hypotonic dehydration (8)Patients who, in the opinion of the principal investigators or investigators, are not likely to participate in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Forced Vital Capacity(FVC) | — |
Countries
Japan
Contacts
Public ContactMasahiro Murakami
LTT Bio-Pharma Co.,Ltd. Department of Clinical Development
Outcome results
None listed