MONICA-SC: A Study to Evaluate the Efficacy, Safety and Tolerability of Blisibimod (A-623) Administration in Subjects With ITP
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)
1 other identifier
interventional
N/A
0 countries
N/A
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2012
CompletedFirst Posted
Study publicly available on registry
June 1, 2012
CompletedStudy Start
First participant enrolled
December 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedJuly 30, 2015
July 1, 2015
6 months
May 23, 2012
July 28, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Achievement of a durable platelet response of 50 billion platelets per liter or higher over the last weeks of treatment.
24 weeks
Secondary Outcomes (8)
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.
24 weeks
Achievement of a transient improvement in platelet count of 50 billion platelets per liter or higher at any 4 weeks of the treatment period.
24 weeks
Change in background corticosteroid dose.
baseline to 24 weeks
Percentage of subjects requiring rescue therapy.
24 weeks
Time to treatment failure.
24 weeks
- +3 more secondary outcomes
Study Arms (2)
Blisibimod
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- to 75 years of age(male or female).
- Diagnosis of ITP according to the guidelines of the American Society of Hematology (ASH) and British Committee for Standards in Hematology.
- 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.
You may not qualify if:
- Subjects who have had a splenectomy for any reason.
- Currently receiving high-dose ITP medications, eltrombopag, romiplostim, rituximab, or investigational therapeutic agents.
- Nursing or pregnant.
- Active infection requiring hospitalization or treatment with parenteral antibiotics within the past 60 days.
- Any known history of bone marrow stem cell disorder.
- Active hepatitis B, active hepatitis C or a documented history of HIV, hepatitis B, or hepatitis C.
- Liver disease.
- Malignancy within the past 5 years.
- History of active tuberculosis (TB) or history of TB infection.
- Subject has not yet completed at least 3 months or 5 half-lives (whichever is longer) since ending other investigational study.
- History of congenital immunodeficiency.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 23, 2012
First Posted
June 1, 2012
Study Start
December 1, 2015
Primary Completion
June 1, 2016
Last Updated
July 30, 2015
Record last verified: 2015-07