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

Idiopathic Thrombocytopenic Purpura Clinical Trial

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01609452
• Other study ID #: AN-ITP3321
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• First received: May 23, 2012
• Last updated: July 28, 2015
• Start date: December 2015

Study information

• Verified date: July 2015
• Source: Anthera Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Idiopathic Thrombocytopenic Purpura
• Immune Thrombocytopenic Purpura
• Purpura
• Purpura, Thrombocytopenic
• Purpura, Thrombocytopenic, Idiopathic

Intervention

Biological:
• Blisibimod

Other:
• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Anthera Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Achievement of a durable platelet response of 50 billion platelets per liter or higher over the last weeks of treatment.		24 weeks	No
Secondary	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	No
Secondary	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	No
Secondary	Change in background corticosteroid dose.		baseline to 24 weeks	No
Secondary	Percentage of subjects requiring rescue therapy.		24 weeks	No
Secondary	Time to treatment failure.		24 weeks	No
Secondary	Change in bleeding risk.		baseline to 24 weeks	No
Secondary	Safety profile (AEs, vitals signs, labs)		24 weeks	Yes
Secondary	Biomarker changes from baseline.		baseline to 24 weeks	No