MONICA-SC: A Study to Evaluate the Efficacy, Safety and Tolerability of Blisibimod (A-623) Administration in Subjects With ITP

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01609452
Recruitment Status : Withdrawn
First Posted : June 1, 2012
Last Update Posted : July 30, 2015
Information provided by (Responsible Party):
Anthera Pharmaceuticals

Brief Summary:
The purpose of this study is to evaluate efficacy, safety and tolerability of blisibimod when administered on top of standard-of-care to subjects with Immune Thrombocytopenic Purpura (ITP).

Condition or disease Intervention/treatment Phase
Immune Thrombocytopenic Purpura Idiopathic Thrombocytopenic Purpura Biological: Blisibimod Other: Placebo Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: MONICA-SC: A Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study to Evaluate the Efficacy, Safety and Tolerability of Blisibimod (A-623) Administration in Subjects With Immune Thrombocytopenic Purpura (ITP)
Study Start Date : December 2015
Estimated Primary Completion Date : June 2016

Arm Intervention/treatment
Experimental: Blisibimod Biological: Blisibimod
Other Name: A-623

Placebo Comparator: Placebo Other: Placebo

Primary Outcome Measures :
  1. Achievement of a durable platelet response of 50 billion platelets per liter or higher over the last weeks of treatment. [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Achievement of a durable platelet count of 50 billion platelets per liter or higher over the last weeks of treatment under conditions of decreased concomitant steroid medication. [ Time Frame: 24 weeks ]
  2. Achievement of a transient improvement in platelet count of 50 billion platelets per liter or higher at any 4 weeks of the treatment period. [ Time Frame: 24 weeks ]
  3. Change in background corticosteroid dose. [ Time Frame: baseline to 24 weeks ]
  4. Percentage of subjects requiring rescue therapy. [ Time Frame: 24 weeks ]
  5. Time to treatment failure. [ Time Frame: 24 weeks ]
  6. Change in bleeding risk. [ Time Frame: baseline to 24 weeks ]
  7. Safety profile (AEs, vitals signs, labs) [ Time Frame: 24 weeks ]
  8. Biomarker changes from baseline. [ Time Frame: baseline to 24 weeks ]

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 18 to 75 years of age(male or female).
  2. Diagnosis of ITP according to the guidelines of the American Society of Hematology (ASH) and British Committee for Standards in Hematology.
  3. Platelet counts at Screening of 30 billion/L or less for subjects not on ITP medication, or 50 billion/L or less for subjects receiving stable background ITP medication.

Exclusion Criteria:

  1. Subjects who have had a splenectomy for any reason.
  2. Currently receiving high-dose ITP medications, eltrombopag, romiplostim, rituximab, or investigational therapeutic agents.
  3. Nursing or pregnant.
  4. Active infection requiring hospitalization or treatment with parenteral antibiotics within the past 60 days.
  5. Any known history of bone marrow stem cell disorder.
  6. Active hepatitis B, active hepatitis C or a documented history of HIV, hepatitis B, or hepatitis C.
  7. Liver disease.
  8. Malignancy within the past 5 years.
  9. History of active tuberculosis (TB) or history of TB infection.
  10. Subject has not yet completed at least 3 months or 5 half-lives (whichever is longer) since ending other investigational study.
  11. History of congenital immunodeficiency.

Responsible Party: Anthera Pharmaceuticals Identifier: NCT01609452     History of Changes
Other Study ID Numbers: AN-ITP3321
First Posted: June 1, 2012    Key Record Dates
Last Update Posted: July 30, 2015
Last Verified: July 2015

Keywords provided by Anthera Pharmaceuticals:
Immune Thrombocytopenic Purpura
Idiopathic Thrombocytopenic Purpura
Chronic ITP

Additional relevant MeSH terms:
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Blood Coagulation Disorders
Hematologic Diseases
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Blood Platelet Disorders
Immune System Diseases
Hemorrhagic Disorders
Autoimmune Diseases