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

Anthera Pharmaceuticals logo

Anthera Pharmaceuticals

Status and phase

Withdrawn
Phase 3
Phase 2

Conditions

Immune Thrombocytopenic Purpura
Idiopathic Thrombocytopenic Purpura

Treatments

Biological: Blisibimod
Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01609452
AN-ITP3321

Details and patient eligibility

About

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).

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

0 participants in 2 patient groups, including a placebo group

Blisibimod
Experimental group
Treatment:
Biological: Blisibimod
Placebo
Placebo Comparator group
Treatment:
Other: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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