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Clinical Research & Trials

USO 24196

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of Mezagitamab Subcutaneous Injection in Participants with Chronic Primary Immune Thrombocytopenia (TAK-079-3002)

 

Disease Types: Lymphoma & Hematologic

Eligibility Requirements:

The participant has been diagnosed with ITP that has persisted for at least 12 months.

The participant's diagnosis of ITP is supported by a prior response to an ITP therapy.

The participant has evidence of insufficient response or intolerance to at least 1 currently available first-line therapy for treatment of ITP and at least 1 currently available second-line therapy for treatment of ITP.

The participant has a mean platelet count of <30,000/μL  

If the participant is receiving allowed standard-of-care treatment for ITP at screening, and continued use is intended, treatment may continue during the trial if the dose, and frequency have been stable for at least 4 weeks before receiving the first dose of IMP (i.e., Day 1), and are expected to remain stable throughout the trial.

   

If the participant is an individual with potential for pregnancy, the participant is not pregnant as confirmed by negative human chorionic gonadotropin during screening, and before the first dose of trial intervention.

  

For more details on this trial CLICK HERE .

Available at: