Phase II double blind trial of PC-SOD in patients with idiopathic interstitial pneumonias

UMIN ID: UMIN000000752

Registered date:27/06/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Idiopathic interstitial pneumonias(GradeIII to IV)
• Date of first enrollment: 2007/06/01
• Target sample size: 45
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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 dismutase) is administered over 1 hour once a day for consecutive 28 days.
Intravenous infusion of placebo of PC-SOD(lecithinized superoxide dismutase) is administered over 1 hour once a day for consecutive 28 days.

Outcome(s)

• Primary Outcome: Forced Vital Capacity(FVC)

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: LTT Bio-Pharma Co.,Ltd.
• Source(s) of Monetary Support: LTT Bio-Pharma Co.,Ltd.