UMIN-CTR Clinical Trial

Basic information
Public title	Phase III Clinical Study on ART-123 in patients with disseminated intravascular coagulation (DIC) directly caused by malignant hematopoietic tumors or infections (Multicenter double-blind randomized parallel group comparative study with heparin sodium as control drug)
Acronym	Phase III Clinical Study on ART-123 in patients with disseminated intravascular coagulation (DIC) directly caused by malignant hematopoietic tumors or infections
Scientific Title	Phase III Clinical Study on ART-123 in patients with disseminated intravascular coagulation (DIC) directly caused by malignant hematopoietic tumors or infections (Multicenter double-blind randomized parallel group comparative study with heparin sodium as control drug)
Scientific Title:Acronym	Phase III Clinical Study on ART-123 in patients with disseminated intravascular coagulation (DIC) directly caused by malignant hematopoietic tumors or infections
Region	Japan

Condition
Condition	Disseminated intravascular coagulation (DIC) directly caused by malignant hematopoietic tumors or infections
Classification by specialty	Medicine in general Hematology and clinical oncology Infectious disease Emergency medicine Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objective of this study as a phase III clinical study on ART-123 is to examine the efficacy (by non-inferiority verification with DIC restoration rate as the primary evaluation variable) and safety of ART-123. The study is conducted by a multicenter double-blind randomized parallel group comparison (double-dummy method, telephone-registration method) with heparin sodium as the control drug, in patients with disseminated intravascular coagulation (DIC) directly caused by malignant hematopoietic tumors or infections.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase III

Assessment
Primary outcomes	DIC restoration rate
Key secondary outcomes	Course of hemorrhage symptoms; Outcome of subjects; Rate of improvement of blood clotting test findings; Rate of improvement of organ symptoms; General improvement rate; Incidence rate of adverse events related to hemorrhage symptoms

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Active
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	ART-123 (real drug or placebo) is administered at a dose of 0.06 mg/kg/day by intravenous drip for 30 min. This treatment is replaced once daily for 6 days.
Interventions/Control_2	Heparin sodium (real drug or placebo) is administered at a daily dose of 8 units/kg/hr by intravenous drip for 24 hrs. This treatment is replaced for 6 days.
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	15 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(i)Patients given a diagnosis of DIC on the basis of criteria established by the DIC research group of the Ministry of Health and Welfare of Japan(1988 Revision). (ii)Patients with malignant hematopoietic tumors or infections as underlying diseases which directly caused DIC. -Details of malignant hematopoietic tumors: Acute myelocytic leukemia, acute lymphocytic leukemia, chronic myelocytic leukemia, chronic lymphocytic leukemia, adult T-cell leukemia, malignant lymphoma, osteomyelodysplasia, multiple myeloma, and others. -Details of infections: Sepsis, pneumonia, urinary tract infection, biliary tract infection, viremia, peritonitis, abscess, burn/trauma/wound infections, and others. (iii)Inpatients (can be discharged after examinations/observations at the completion (or discontinuance) of administration of the study drug) (iv)Without distinction of sex
Key exclusion criteria	(i)Patients showing lethal or life-threatening hemorrhage (intracranial, gastrointestinal or pulmonary hemorrhage, and others). (ii)Patients having a strong possibility of onset of lethal or life-threatening hemorrhage. (iii)Patients with a history (within the past one year) of cerebrovascular disorders (cerebral hemorrhage, cerebral infarction, and others). (iv)Patients who recently underwent surgery of the central nervous system or were subjected to trauma. (v)Children under 15. (vi)Patients with a history of hypersensitivity to protein preparations or unfractionated heparin preparations. (vii)Pregnant women, nursing mothers or possibly pregnant women. (viii)Patients whose skin test for ART-123 is positive. (ix)Patients undergoing treatment by dialysis or with drug excretion severely damaged by serious renal disorder. (x)Patients with serious hepatopathy such as fulminant hepatitis, uncompensated liver cirrhosis and others. (xi)Patients believed to die early even if they recovered from DIC, making it difficult to ensure a sufficient period of administration of the study drug and to obtain data on the efficacy and safety. (xii)Patients given a study drug within last 6 months. (xiii)Patients participating in the past trial of ART-123. (xiv)Patients receiving preadministration of unfractionated heparin for DIC (within 3 months before the start of administration of study drug). (xv)Other patients judged to be inappropriate at the discretion of investigators (or assistant investigators).
Target sample size	220

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hidehiko Saito
Organization	National Hospital Organization, Nagoya Medical Center
Division name	Director
Zip code
Address	4-1-1, San-nomaru, Naka-ku, Nagoya City, Aichi 460-0001, Japan
TEL	052-951-1111
Email

Public contact
Name of contact person	1st name Middle name Last name
Organization	Asahi Kasei Pharma Corporation
Division name	Clinical Development Center
Zip code
Address	9-1 Kanda Mitoshiro-cho, Chiyoda-ku, Tokyo 101-8481 Japan
TEL
Homepage URL
Email	ct-info@om.asahi-kasei.co.jp

Sponsor
Institute	Asahi Kasei Pharma Corporation
Institute
Department

Funding Source
Organization	Asahi Kasei Pharma Corporation
Organization
Division
Category of Funding Organization	Profit 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	YES
Study ID_1	JapicCTI-050059
Org. issuing International ID_1	Japan Pharmaceutical Information Center
Study ID_2
Org. issuing International ID_2
IND to MHLW	1992年10月1日　5回

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2006 Year 02 Month 07 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	2000 Year 06 Month 09 Day
Date of IRB
Anticipated trial start date	2000 Year 11 Month 01 Day
Last follow-up date	2005 Year 05 Month 01 Day
Date of closure to data entry	2005 Year 10 Month 01 Day
Date trial data considered complete	2005 Year 10 Month 01 Day
Date analysis concluded	2005 Year 11 Month 01 Day

Other
Other related information

Management information
Registered date	2006 Year 02 Month 07 Day
Last modified on	2006 Year 02 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000420

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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