UMIN-CTR Clinical Trial

Public title

Phase I study for the efficacy and the safety of the perioperative urinastatin therapy in chest surgical patients with interstitial pneumonia.

Acronym

Phase I study for the perioperative urinastatin therapy in chest surgical patients with interstitial pneumonia

Scientific Title

Phase I study for the efficacy and the safety of the perioperative urinastatin therapy in chest surgical patients with interstitial pneumonia.

Scientific Title:Acronym

Phase I study for the perioperative urinastatin therapy in chest surgical patients with interstitial pneumonia

Region

Japan

Condition

interstitial pneumonia, lung cancer,
metastatic lung tumor, pneumothorax

Classification by specialty

Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

We are going to evaluate the safety and efficacy of perioperative ulinastatin therapy for chest surgical patient including lung tumor, lung cancer, and others with interstial pneumonia.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I

Primary outcomes

Judging whether a side effect of the ulinastatin appeared.
Evaluating the kind of the side effect, frequency, grade of the ulinastatin.

Key secondary outcomes

Judging whether acute exacerbation of the postoperative interstitial pneumonia appeared.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

From the 2nd day before an operation, ulinastatin was administered as a 30 min infusion of 300000 U for 3 consecutive days. The dose of the ulinastatin reduced by 100000 unit every 3rd day.

Interventions/Control_2

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

Not applicable

Gender

Male and Female

Key inclusion criteria

1.Preoperative chest CT scans IP findings were checked by a radiologist.
The criteria for identifying IPF on a chest high-resolution computed tomography (HRCT) were subpleural space shadow, honeycomb formation, reticular shadow, tractional bronchitis/bronchioles etc., and consolidation.
2.IP findings such as fine crackles at the bilateral lower lung were checked by a pulmonologist.
3.Performance status of 0 to 1
4.The functions of the main organs such as bone marrow, heart, liver, and kidney are kept. Within 2 weeks before registration, the criteria are follows.
White blood cell count
>=3000mm3-<=12000mm3
Neutrophil count
>=1500mm3-<=5000mm3
Platelet count >=50000mm3
Hemoglobin >=8g/dL
Serum KL-6 >=500U/mL
Aspartate aminotransferase (AST) and
Alanine aminotransferase (ALT);
2 times upper limit of normal in our
hospital
5.A case that an operation under the general anesthesia is possible.
6.A case that a document agreement by the person himself was provided about examination participation.

Key exclusion criteria

1.Having the history of allergic reaction against ulinastatin.
2.Asbestosis.
3.Chronic hypersensitivity pneumonitis.
4.Sarcoidosis.
5.Pregnancy.

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Onuki Takamasa

Organization

Tokyo Women's Medical University of Medicine

Division name

Department of Surgery I

Zip code

Address

8-1Kawada-cho, Shinjuku-ku, Tokyo

TEL

03-3353-8111

Email

Name of contact person

1st name
Middle name
Last name

Organization

Tokyo Women's Medical University of Medicine

Division name

Department of Surgery I

Zip code

Address

8-1Kawada-cho, Shinjuku-ku, Tokyo

TEL

03-3353-8111

Homepage URL

Email

Institute

Tokyo Women's Medical University of Medicine, Department of Surgery I

Institute

Department

Personal name

Organization

Tokyo Women's Medical University of Medicine, Department of Surgery I

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

2010

Year

03

Month

06

Day

URL releasing protocol

Publication of results

Unpublished

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

Open public recruiting

Date of protocol fixation

2009

Year

11

Month

10

Day

Date of IRB

Anticipated trial start date

2010

Year

03

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2010

Year

03

Month

06

Day

Last modified on

2010

Year

03

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003990