Thrombotic microangiopathy (TMA) disorders MedDRA version: 9.1 Level: LLT Classification code 10009731 Term: Coagulation disorder
Conditions
Interventions
Product Name: ARC1779
Product Code: ARC1779
Pharmaceutical Form: Solution for infusion
CAS Number: 934868-74-3
Current Sponsor code: ARC1779
Other descriptive name: Poly(oxy-1,2-ethanediyl), a-hydro
Sponsors
Archemix Corp
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female; =18 to =75 years of age; Diagnosis of TMA based on presence of: Thrombocytopenia, defined as a platelet count =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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). Patients who have again become acutely ill following recent treatment and achievement of a brief remission of acute TMA may not be enrolled in the study if ANY of the following conditions are met: The last plasma exchange of the patient’s preceding course of treatment occurred less than 7 days prior; The patient underwent splenectomy during the preceding course of treatment; The new course of plasma exchange has been ongoing for more than 3 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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; • 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.;Secondary Objective: Exploratory objectives Some patients may undergo cranial MRI once prior to, and once again ~6 weeks after the start of study drug treatment.;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. | — |
Countries
Austria, Italy, United Kingdom
Outcome results
None listed