A Randomized, Double-blind, Placebo-controlled, Clinical Outcome study of ARC1779 Injection in Patients with Thrombotic Microangiopathy - Study of ARC1779 Injection in Patients with Thrombotic Microangiopathy

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

• Male or female;
• =18 to =75 years of age;
• Diagnosis of TMA based on presence of:
- Thrombocytopenia, defined as a platelet count <100 x 109 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

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);
• Clinical diagnosis of DIC verified by corresponding laboratory values for Ddimer, 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

Secondary Outcome Measures

Name	Time	Method

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