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.
Verified March 2013 by Anthera Pharmaceuticals
Sponsor:
Anthera Pharmaceuticals
Information provided by (Responsible Party):
Anthera Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01609452
First received: May 23, 2012
Last updated: March 20, 2013
Last verified: March 2013
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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 2013 |
| Estimated Primary Completion Date: | June 2015 (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:
- 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.
- History of congenital immunodeficiency.
Contacts and Locations
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: | March 20, 2013 |
| 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 Blood Coagulation Disorders Hematologic Diseases Hemorrhage Pathologic Processes Skin Manifestations |
Signs and Symptoms Thrombotic Microangiopathies Thrombocytopenia Blood Platelet Disorders Immune System Diseases Hemorrhagic Disorders Autoimmune Diseases |
ClinicalTrials.gov processed this record on May 19, 2013