UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009591
Receipt No. R000011210
Scientific Title Clinical study of defibrotide in safety and pharmacokinetics in healthy adult subjects
Date of disclosure of the study information 2013/01/10
Last modified on 2014/06/10

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Clinical study of defibrotide in safety and pharmacokinetics in healthy adult subjects
Acronym FMU-DF-001
Scientific Title Clinical study of defibrotide in safety and pharmacokinetics in healthy adult subjects
Scientific Title:Acronym FMU-DF-001
Region
Japan

Condition
Condition Veno Occulisive Disease
Classification by specialty
Hematology and clinical oncology Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Investigation for safety and pharmacokinetics of defibrotide in Japanese healthy adult subjects.

Investigation for fibrinolytic and coagulation activity of defbrotide.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes Presence of dose-limiting toxicities of 2 doses of defibrotide
Key secondary outcomes Profile of adverse effects of defibrotide
Pharmacokinetics of defibrotide
Fibrinolytic and coagulation activit

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-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 defibrotide
Interventions/Control_2 Placebo(physical saline)
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
45 years-old >=
Gender Male
Key inclusion criteria 1. Male Japanese
2. >=20 years old and <=45 years old at voluntary written consent
3. >=50.0 kg and <100.0 kg, and >=18.5 and <25.0 of BMI at screening
4. No history of taken drugs within 6 days at screening
5. Clinical laboratory values are within normal levels in screening and before administration in hospital.
6. Normal in subjective and objective symptoms.
7. Voluntary written consent by themselves is given before screening and is reconfirmed after entering in hospital.
Key exclusion criteria 1. History of abnormal function in CNS, cardiovascular system, respiratory sytem, blood/hematopoietic system, gastroenteric system, liver/kidney, thyroid, pituitary gland, adrenal gland and so on and it is difficult to keep safety of subjects during clinical study.
2. Known hypersensitivity to some drugs
3. Abuse of alcohol or drugs
4. Known active chronic hepatitis B or C, active syphilis and human immunodeficiency virus infection
5. History of blood taken
*>=1200ml of all blood within 1 year before screening
*>=400ml of all blood with 84 days before screening
*>=200ml of all blood within 28 days before screening
*taken blood component within 14 days
*taken all blood or blood component after screening and before clinical laboratory tests at entering in hospital
6. Treatment with any investigational compound within 120 days before screening or after screening
7. Treatment by other doctors within 28 days before the dose of study drug
8. Any serious medical or psychiatric illness that could, in the opinion of the investigator, potentially interfere with the completion of treatment according to this protocol.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuo Umemura
Organization Hamamatsu University Hospital
Division name Center for clinical research
Zip code
Address Handayama 1-20-1, Higashi-ku, Hamamatsu, Japan
TEL 053-435-2006
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kazuo Umemura
Organization Hamamatsu University Hospital
Division name Center for clinical research
Zip code
Address Handayama 1-20-1, Higashi-ku, Hamamatsu, Japan
TEL 053-435-2006
Homepage URL http://www2.hama-med.ac.jp/w6a/trial/index.html
Email umemura@hama-med.ac.jp

Sponsor
Institute Fukushima Medical University Clinical Oncology Center, Division of Pediatric Oncology, Atsushi Kikuta
Institute
Department

Funding Source
Organization ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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 2012.11.20

Institutions
Institutions 浜松医大大学病院(静岡県)

Other administrative information
Date of disclosure of the study information
2013 Year 01 Month 10 Day

Related information
URL releasing protocol
Publication of results Unpublished

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
2013 Year 01 Month 10 Day
Date of IRB
Anticipated trial start date
2013 Year 01 Month 15 Day
Last follow-up date
2013 Year 04 Month 01 Day
Date of closure to data entry
2013 Year 04 Month 01 Day
Date trial data considered complete
2013 Year 05 Month 01 Day
Date analysis concluded
2013 Year 07 Month 01 Day

Other
Other related information

Management information
Registered date
2012 Year 12 Month 20 Day
Last modified on
2014 Year 06 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011210

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.