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Clinical Outcome Study of ARC1779 Injection in Patients With Thrombotic Microangiopathy

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ClinicalTrials.gov Identifier: NCT00726544
Recruitment Status : Terminated (Enrollment into study was slower than expected.)
First Posted : August 1, 2008
Last Update Posted : November 26, 2009
Sponsor:
Information provided by:
Archemix Corp.

July 30, 2008
August 1, 2008
November 26, 2009
December 2008
December 2010   (Final data collection date for primary outcome measure)
The incidence of the clinical composite of death (all-cause mortality), stroke, coma, seizures, renal failure, or acute myocardial infarction (AMI) [ Time Frame: 6 weeks post randomization ]
Same as current
Complete list of historical versions of study NCT00726544 on ClinicalTrials.gov Archive Site
  • Neurocognitive function is to be assessed with the CogState® test system. [ Time Frame: Once during the hospitalization period and again at the 6 week clinic visit. ]
  • The incidence of death, stroke, or acute renal failure/injury requiring dialysis is to be assessed. [ Time Frame: During the extended clinical follow-up for each patient from the time of the 6 week clinic visit until the study is closed. ]
  • Safety- and efficacy-related clinical laboratory parameters and biomarkers will be analyzed in relation to ARC1779 exposure in terms of the dose administered and the observed plasma concentration. [ Time Frame: During initial hospitalization and at 6 week clinic visit. ]
  • The incidence of the composite of complications associated with plasma exchange therapy (i.e., catheter-related infection, thrombosis, internal hemorrhage, or pneumothorax) is to be assessed. [ Time Frame: During initial hospitalization and at the 6 week clinic visit. ]
Same as current
Not Provided
Not Provided
 
Clinical Outcome Study of ARC1779 Injection in Patients With Thrombotic Microangiopathy
A Randomized, Double-blind, Placebo Controlled, Clinical Outcome Study of ARC1779 Injection in Patients With Thrombotic Microangiopathy
The purpose of this ascending-dose research study is to determine whether the administration of ARC1779 Injection improves subject's health profile by protecting the brain, heart, and kidney from damage due to formation of small blood clots in blood vessels. It will also determine the safety of ARC1779 Injection, how ARC1779 Injection enters and leaves the blood and tissue over time, and its effect on laboratory tests related to blood clotting, heart and brain function, and other body systems.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Thrombotic Microangiopathy
  • Thrombotic Thrombocytopenic Purpura
  • Drug: ARC 1779 Placebo
    ARC1779 Injection or placebo is administered intravenously to patients as an initial loading dose followed by continuous infusion of up to 14 days plus 2 day taper.
  • Drug: ARC1779 Injection
    ARC1779 Injection or placebo is administered intravenously to patients as an initial loading dose followed by continuous infusion of up to 14 days plus 2 day taper. Treatment with ARC1779 Injection is to be given at low dosage that is intended to produce target steady-state ARC1779 plasma concentrations during infusion of 3μg/mL.
  • Drug: ARC1779 Injection
    ARC1779 Injection or placebo is administered intravenously to patients as an initial loading dose followed by continuous infusion of up to 14 days plus 2 day taper. Treatment with ARC1779 Injection is to be given at low dosage that is intended to produce target steady-state ARC1779 plasma concentrations during infusion of 6μg/mL.
  • Drug: ARC1779 Injection
    ARC1779 Injection or placebo is administered intravenously to patients as an initial loading dose followed by continuous infusion of up to 14 days plus 2 day taper. Treatment with ARC1779 Injection is to be given at low dosage that is intended to produce target steady-state ARC1779 plasma concentrations during infusion of 12μg/mL.
  • Placebo Comparator: Placebo
    Intervention: Drug: ARC 1779 Placebo
  • Active Comparator: Low Dose
    Intervention: Drug: ARC1779 Injection
  • Active Comparator: Medium Dose
    Intervention: Drug: ARC1779 Injection
  • Active Comparator: High Dose
    Intervention: Drug: ARC1779 Injection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
100
Same as current
March 2011
December 2010   (Final data collection date for primary outcome measure)

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 antiglobulin 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.

Patients who have again become acutely ill following recent treatment and achievement of a brief remission of acute TMA may be enrolled in the study if ALL of the following conditions are met:

  • Disease activity in the patient in unabated (e.g. persistent thrombocytopenia and microangiopathic hemolytic anemia with ongoing neurological symptoms and/or troponin elevation);
  • The last plasma exchange of the patient's preceding course of treatment occurred at least 7 days prior;
  • The patient did not undergo splenectomy during the preceding course of treatment;
  • The new course of plasma exchange has not been ongoing for more than 3 days.

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.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Canada,   Italy,   United Kingdom,   United States
 
 
NCT00726544
ARC1779-006
Yes
Not Provided
Not Provided
Dr, James Gilbert, Archemix
Archemix Corp.
Not Provided
Not Provided
Archemix Corp.
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP