A Randomized, Double-blind, Placebocontrolled, Clinical Outcome Study of ARC1779 Injection in Patients with Thrombotic Microangiopathy - ND
- Conditions
- Thromobotic microangiopathy (TMA) disordersMedDRA version: 9.1Level: LLTClassification code 10009731Term: Coagulation disorder
- Registration Number
- EUCTR2008-001872-54-IT
- Lead Sponsor
- ARCHEMIX CORP
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
Patients who meet the following criteria are eligible for this study: Male or female; 18 to 75 years of age; Diagnosis of TMA based on presence of: Thrombocytopenia, defined as a platelet count <100 x 10^9 per liter; Microangiopathic hemolytic anemia, defined by negative findings on direct antiglobin test, and evidence of accelerated red blood cell (RBC) production and destruction); AND Absence of a clinically apparent alternative explanation for thrombocytopenia and anemia, e.g., disseminated intravascular coagulation (DIC), eclampsia, HELLP syndrome, Evans syndrome; Females: non-pregnant and commit to use of effective, redundant methods of contraception (i.e., for both self and male partner) throughout the study and for at least 30 days after discontinuation of study drug treatment; Males: commit to use of a medically acceptable contraceptive (abstinence or use of a condom with spermicide) throughout the study and for at least 30 days after discontinuation of study drug treatment; Not received an unlicensed investigational agent (drug, device, or blood-derived product) within 30 days prior to randomization, and may not receive such an investigational agent in the 30 days post-randomization (note: investigational use for treatment of TMA of a licensed immunomodulator, e.g., rituximab, is permitted at any time relative to randomization); Capable of understanding and complying with the protocol, and he/she (or a legal representative) must have signed the informed consent document prior to performance of any study-related procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Patients who meet the following criteria are NOT eligible for this study: Females: pregnant or <24 hours post-partum, or breastfeeding; History of bleeding diathesis or evidence of active abnormal bleeding within the previous 30 days; Disseminated malignancy or other co-morbid illness limiting life expectancy to ≤3 months independent of the TMA disorder. Diagnosis other than TMA which can account for the findings of thrombocytopenia and hemolytic anemia (e.g., DIC, HELLP syndrome, Evans syndrome); Diagnosis of DIC verified by laboratory values for D-dimer, fibrinogen, prothrombin time (PT), and activated partial thromboplastin time (aPTT).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the ability of ARC1779 Injection to improve clinical outcome by protecting brain, heart, and kidney from damage due to formation of disseminated platelet thrombi in the microcirculation; To evaluate the overall safety and tolerability of ARC1779 Injection;;Secondary Objective: To assess the concentration-response of ARC1779 for efficacy- and safety-related effects; To assess the concentration-response relationships among ARC1779 pharmacokinetic (PK) and pharmacodynamic (PD) parameters.;Primary end point(s): Composite of clinical events and biomarker evidence for injury to the target organs commonly affected by TMA, i.e. brain, heart and kidney.
- Secondary Outcome Measures
Name Time Method