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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | C000000327 |
Receipt No. | 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 |
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 | |
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Condition | ||||||
Condition | Disseminated intravascular coagulation (DIC) directly caused by malignant hematopoietic tumors or infections | |||||
Classification by specialty |
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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 |
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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. | |
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Eligibility | ||||
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Age-upper limit |
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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 |
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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). |
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Target sample size | 220 |
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Name of lead principal investigator |
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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 |
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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 | |
Institute | Asahi Kasei Pharma Corporation |
Institute | |
Department |
Funding Source | |
Organization | Asahi Kasei Pharma Corporation |
Organization | |
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Category of Funding Organization | Profit organization |
Nationality of Funding Organization | Japan |
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IRB Contact (For public release) | |
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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 |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
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Recruitment status | Completed | ||||||
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Last modified on |
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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 | |
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Research case data | |
Registered date | File name |