UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009573 |
|---|---|
| Receipt number | R000008096 |
| Scientific Title | PC-SOD NE (PhaseIIa) -Repeated Dose Study in IPF patients- |
| Date of disclosure of the study information | 2012/12/18 |
| Last modified on | 2012/12/18 14:47:01 |
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Basic information
Public title
PC-SOD NE (PhaseIIa)
-Repeated Dose Study in IPF patients-
Acronym
PC-SOD NE (PhaseIIa)
Scientific Title
PC-SOD NE (PhaseIIa)
-Repeated Dose Study in IPF patients-
Scientific Title:Acronym
PC-SOD NE (PhaseIIa)
Region
| Japan |
Condition
Condition
idiopathic pulmonary fibrosis
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
PC-SOD NE was repeatedly inhaled once daily for 7 days at doses of 10 mg ( step 1 ) or 20 mg ( step 2 ), or once daily for 14 days at a dose of 40 mg ( step 3 ). In placebo group, placebo was repeatedly inhaled once daily for 28 days. After administration, patients were continuously hospitalized for a further 7 days for post-treatment observation period (total duration of hospitalization, 5 weeks (35 nights and 36 days)).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(1)Safety
Adverse event
subjective, objective
weight
vital signs
12-lead electrocardiogram
lung function test
Clinical test
antibody titer in blood of PC-SOD
(2)Pharmacological effect
Biomarker(LDH, SP-A, SP-D, KL-6)
(3)Pharmacokinetics
blood serum concentration of PC-SOD
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
PC-SOD NE was repeatedly inhaled once daily for 7 days at doses of 10 mg ( step 1 ) or 20 mg ( step 2 ), or once daily for 14 days at a dose of 40 mg ( step 3 ).
Interventions/Control_2
Placebo was repeatedly inhaled once daily for 7days at doses of 10 mg ( step 1 ) or 20 mg ( step 2 ), or once daily for 14 days at a dose of 40 mg ( step 3 ).
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)Sex:Male or Female
(2)Age:20-80 years
(3)Japanese
(4)Patients diagnosed as IIP by X-ray and HCRT
(5)
LDH 350U/L<=
SP-A 65ng/mL<=
(6)All patients must provide written informed consent
(7)Patients who the principal Investigator or the investigator judges medically suitable for inclusion in the clinical investigation based on examination at screening conduceted within 28days prior to study drug administration
Key exclusion criteria
(1)Exclusion criteria involving similar diseases
1.Patients who's IPF was clearly caused by pharmaceuticals
2.Patients diagnosed with COPD or asthma or airway infection
(2)Exclusion criteria due to previous treatment
(3)Patients who are moderate intake of alcohol or alcoholics
(4)Patients of chemical dependency
(5)Patients who are smokers within a month(6)Patients are sensitive to any drugs (alldrugs prescribed or commercially available drugs) or have history of sensitivity to the drugs
(7)Before 4 wee
(8)Patients who participated in another clinical study within 4 months prior to the administration period of the study drug
(9)Patients who are pregnant or possibly pregnant, or nursing
(10)Patients who have taken PC-SOD previously in their medical history
Target sample size
4
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tohru Mizushima Ph. D. |
Organization
LTT Bio Pharma Co., LTD.
Division name
Chief technology officer
Zip code
Address
Shiocme Building 3F 1-2-20 Kaigan, Minato-ku, Tokyo 105-0022 Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
LTT Bio Pharma Co., LTD.
Division name
Clinical Develpment
Zip code
Address
TEL
03-5733-7394
Homepage URL
Sponsor or person
Institute
LTT Bio Pharma Co., LTD.
Institute
Department
Personal name
Funding Source
Organization
LTT Bio Pharma Co., LTD.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2012 | Year | 12 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
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
| 2011 | Year | 01 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 05 | Month | 31 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 12 | Month | 18 | Day |
Last modified on
| 2012 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008096
