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: Rationale and Design of a Phase 3b Multicenter, Randomized, Double-Blind Placebo-Controlled, Parallel-Group Trial with an Open-Label Extension Phase to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Pediatric Patients with Immune Thrombocytopenia

Researchers

Presenter

  • Rachael F. Grace

Principal Investigators

  • Xiaoqiang Xue

  • Brian Jamieson

Medical Centers

  • Dana-Farber/Boston Children's Cancer and Blood Disorders Center, Harvard Medical School, Boston, MA

Locations

  • United States

Companies

  • N/A

Study Components

Therapeutic Area

  • Oncology (ONC)

  • Autoimmune (AI)

  • Blood/haematological Diseases

  • Pulmonary/Respiratory Diseases

  • Cardiovascular (CVS)

Disease

  • Alpha-thalassemia myelodysplasia syndrome

  • Immune thrombocytopenia

  • Venous thrombosis

  • Thrombocytopenia

Biomarkers

  • N/A

Drug/Treatment

  • Avatrombopag

Outcome

  • N/A

Study Design

  • Randomized

  • Efficacy

  • Safety

  • Placebo Control

  • Pharmacokinetics

  • Pharmacodynamics

  • Double Blind/Blinded

  • Open Label

  • Multicenteric

  • Controlled

  • Cohort

  • Parallel Group

Phase

  • III

Study Id's

  • N/A

Sponsors

  • N/A

Result

  • N/A

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