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)

UMIN ID: C000000327

Registered date:07/02/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Disseminated intravascular coagulation (DIC) directly caused by malignant hematopoietic tumors or infections
• Date of first enrollment: 2000/11/01
• Target sample size: 220
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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.
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.

Outcome(s)

• Primary Outcome: DIC restoration rate
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: 15years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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).

Related Information

• Primary Sponsor: Asahi Kasei Pharma Corporation
• Source(s) of Monetary Support: Asahi Kasei Pharma Corporation
• Secondary ID(s): JapicCTI-050059