UMIN-CTR Clinical Trial

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

idiopathic pulmonary fibrosis

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Single blind -participants are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

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

Email

Institute

LTT Bio Pharma Co., LTD.

Institute

Department

Personal name

Organization

LTT Bio Pharma Co., LTD.

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2012

Year

12

Month

18

Day

URL releasing protocol

Publication of results

Published

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

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 related 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