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)

Anthera Pharmaceuticals0 sitesDecember 2015

ConditionsImmune Thrombocytopenic Purpura Idiopathic Thrombocytopenic Purpura

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Immune Thrombocytopenic Purpura
Sponsor: Anthera Pharmaceuticals
Primary Endpoint: Achievement of a durable platelet response of 50 billion platelets per liter or higher over the last weeks of treatment.
Status: Withdrawn
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

December 2015

End Date

June 2016

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Anthera Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•18 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.

Exclusion Criteria

•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.

Outcomes

Primary Outcomes

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 Outcomes

Biomarker changes from baseline.(baseline to 24 weeks)
Change in background corticosteroid dose.(baseline to 24 weeks)
Time to treatment failure.(24 weeks)
Change in bleeding risk.(baseline to 24 weeks)
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)
Percentage of subjects requiring rescue therapy.(24 weeks)
Safety profile (AEs, vitals signs, labs)(24 weeks)