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A Randomized, Double-blind, Placebo Controlled, Clinical Outcome Study of ARC1779 Injection in Patients With Thrombotic Microangiopathy


Phase 2
18 Years
75 Years
Not Enrolling
Both
Thrombotic Microangiopathy, Thrombotic Thrombocytopenic Purpura

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Trial Information

A Randomized, Double-blind, Placebo Controlled, Clinical Outcome Study of ARC1779 Injection in Patients With Thrombotic Microangiopathy


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

The incidence of the clinical composite of death (all-cause mortality), stroke, coma, seizures, renal failure, or acute myocardial infarction (AMI)

Outcome Time Frame:

6 weeks post randomization

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

ARC1779-006

NCT ID:

NCT00726544

Start Date:

December 2008

Completion Date:

March 2011

Related Keywords:

  • Thrombotic Microangiopathy
  • Thrombotic Thrombocytopenic Purpura
  • thrombocytopenia
  • microangiopathic hemolytic anemia
  • von Willebrand Factor
  • ADAMTS13
  • Purpura
  • Purpura, Thrombocytopenic
  • Purpura, Thrombotic Thrombocytopenic
  • Thrombosis
  • Vascular Diseases
  • Thrombotic Microangiopathies

Name

Location

New York Medical CollegeValhalla, New York  10595
University of PennsylvaniaPhiladelphia, Pennsylvania  19104
Northwestern UniversityChicago, Illinois  60611
Washington UniversitySt. Louis, Missouri  63110
The Methodist HospitalHouston, Texas  77030
Indiana University Simon Cancer CenterIndianapolis, Indiana  46202
The Ohio State University Research FoundationColumbus, Ohio  43235