UMIN-CTR Clinical Trial

Basic information
Public title	Phase II double blind trial of PC-SOD in patients with idiopathic interstitial pneumonias
Acronym	Dose finding trial of PC-SOD for idiopathic interstitial pneumonias
Scientific Title	Phase II double blind trial of PC-SOD in patients with idiopathic interstitial pneumonias
Scientific Title:Acronym	Dose finding trial of PC-SOD for idiopathic interstitial pneumonias
Region	Japan

Condition
Condition	Idiopathic interstitial pneumonias(GradeIII to IV)
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This multicenter placebo-controlled double blind trial aims to evaluate the safety and efficacy of daily dose of PC-SOD(40mg and 80mg) in patients with idiopathic interstitial pneumonias.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Forced Vital Capacity(FVC)
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Intravenous infusion of 40mg of PC-SOD(lecithinized superoxide dismutase) is administered over 1 hour once a day for consecutive 28 days.
Interventions/Control_2	Intravenous infusion of 80mg of PC-SOD(lecithinized superoxide dismutase) is administered over 1 hour once a day for consecutive 28 days.
Interventions/Control_3	Intravenous infusion of placebo of PC-SOD(lecithinized superoxide dismutase) is administered over 1 hour once a day for consecutive 28 days.
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key 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
Key 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
Target sample size	45

Research contact person
Name of lead principal investigator	1st name Middle name Last name Shoji Kudo
Organization	Nippon Medical School
Division name	Department of Pulmonary Medicine/Infection and Oncology
Zip code
Address	1-1-5, Sendagi, Bunkyo-ku, Tokyo113-8602, Japan
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name Masahiro Murakami
Organization	LTT Bio-Pharma Co.,Ltd.
Division name	Department of Clinical Development
Zip code
Address	Shiodome Building 3F 1-2-20 Kaigan, Minato-ku, Tokyo 105-0022 Japan
TEL	03-5733-7394
Homepage URL	http://www.ltt.co.jp
Email	murakami@ltt.co.jp

Sponsor
Institute	LTT Bio-Pharma Co.,Ltd.
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	LTT Bio-Pharma Co.,Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2007 Year 06 Month 27 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications	http://www.ltt.co.jp
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2007 Year 04 Month 12 Day
Date of IRB
Anticipated trial start date	2007 Year 06 Month 01 Day
Last follow-up date	2008 Year 03 Month 01 Day
Date of closure to data entry	2008 Year 03 Month 01 Day
Date trial data considered complete	2008 Year 03 Month 01 Day
Date analysis concluded	2008 Year 04 Month 01 Day

Other
Other related information

Management information
Registered date	2007 Year 06 Month 27 Day
Last modified on	2011 Year 11 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000903

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