Clinical trial NCT01609452: MONICA-SC: A Study to Evaluate the Efficacy, Safety and Tolerability of Blisibimod (A-623) Administration in Subjects With ITP
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 type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Immune Thrombocytopenic Purpura
Idiopathic Thrombocytopenic Purpura
Keywords: Immune Thrombocytopenic Purpura
Idiopathic Thrombocytopenic Purpura
Chronic ITP
Lead sponsor: Anthera Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2012-06-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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.

Primary outcomes:
measure: Achievement of a durable platelet response of 50 billion platelets per liter or higher over the last weeks of treatment.
timeFrame: 24 weeks
Secondary outcomes:
measure: 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.
timeFrame: 24 weeks
measure: Achievement of a transient improvement in platelet count of 50 billion platelets per liter or higher at any 4 weeks of the treatment period.
timeFrame: 24 weeks
measure: Change in background corticosteroid dose.
timeFrame: baseline to 24 weeks
measure: Percentage of subjects requiring rescue therapy.
timeFrame: 24 weeks
measure: Time to treatment failure.
timeFrame: 24 weeks
measure: Change in bleeding risk.
timeFrame: baseline to 24 weeks
measure: Safety profile (AEs, vitals signs, labs)
timeFrame: 24 weeks
measure: Biomarker changes from baseline.
timeFrame: baseline to 24 weeks
Other outcomes:
Locations:
Study officials:
References: