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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2014 by Anthera Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Anthera Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01609452
First received: May 23, 2012
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Immune Thrombocytopenic Purpura
Idiopathic Thrombocytopenic Purpura
Biological: Blisibimod
Other: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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)

Resource links provided by NLM:


Further study details as provided by Anthera Pharmaceuticals:

Primary Outcome Measures:
  • Achievement of a durable platelet response of 50 billion platelets per liter or higher over the last weeks of treatment. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change in background corticosteroid dose. [ Time Frame: baseline to 24 weeks ] [ Designated as safety issue: No ]
  • Percentage of subjects requiring rescue therapy. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Time to treatment failure. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change in bleeding risk. [ Time Frame: baseline to 24 weeks ] [ Designated as safety issue: No ]
  • Safety profile (AEs, vitals signs, labs) [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Biomarker changes from baseline. [ Time Frame: baseline to 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: December 2015
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Blisibimod Biological: Blisibimod
Other Name: A-623
Placebo Comparator: Placebo Other: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01609452

Contacts
Contact: Colin Hislop chislop@anthera.com

Sponsors and Collaborators
Anthera Pharmaceuticals
  More Information

No publications provided

Responsible Party: Anthera Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01609452     History of Changes
Other Study ID Numbers: AN-ITP3321
Study First Received: May 23, 2012
Last Updated: August 5, 2014
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on October 20, 2014