UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000327 |
|---|---|
| Receipt number | R000000420 |
| 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) |
| Date of disclosure of the study information | 2006/02/07 |
| Last modified on | 2006/02/07 20:22:12 |
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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
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
ct-info@om.asahi-kasei.co.jp
Sponsor or person
Institute
Asahi Kasei Pharma Corporation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000420
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