ITP Clinical Trials

Clinical trials are research investigations in which people volunteer to test new treatments, interventions or tests as a means to prevent, detect, treat or manage various diseases or medical conditions. Some investigations look at how people respond to a new intervention and what side effects might occur while others help to determine the best dose of a particular treatment is effective.

There are a number of Clinical Trials available in Australia for the treatment of Immune Thrombocytopenia, which further information available below.
In addition, there are clinical trials ben held internationally. You can review a complete list by visiting ClinicalTrials.gov.

Clinical Trial Register

Status

Trial

Pharmaceutical Sponsor

Trial Summary

Recruiting.

Drug: Efgartigimod PH20 SC

Argenx

ADVANCESC Study

A Study to Evaluate the Efficacy and Safety of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia.

This is a phase 3, multicenter, randomized, double-blinded, placebo-controlled, parallel-group trial to evaluate the efficacy, safety, and effect on QoL/PRO of efgartigimod PH20 SC treatment in adult patients with primary ITP.

Recruiting.

Drug: Rilzabrutinib

Sanofi

LUNA 3 – Rilzabrutinib

This is a randomized, double-blind study of rilzabrutinib in patients with persistent or chronic ITP, with an average platelet count of <30,000/μL (and no single platelet count >35,000/μL) on two counts at least 5 days apart in the 14 days before treatment begins. Patients will receive rilzabrutinib or placebo 400mg twice daily.

Patients who respond per specified criteria at the end of the Open-Label Period will be able to enter a 12-month Long-Term Extension (LTE).

Recruiting.

Drug: PF-06835375

Pfizer

PF-06835375

This is a Phase 2, open-label, single arm, multicenter, multiple subcutaneous injection, safety and efficacy study of PF-06835375 in adult participants with primary immune thrombocytopenia (ITP). This study will focus on participants with persistent (>3 months and ≤12 months), or chronic (>12 months) ITP.

Active. Not Recruiting.

Drug: PRN1008

Sanofi (Principia Biopharma)

PRN1008

This is a 2 part (Part A and B) adaptive, open-label, dose-finding study of PRN1008 in patients with ITP who are refractory or relapsed with no available and approved therapeutic options, with a platelet count <30,000/μL on two counts no sooner than 7 days apart in the 15 days before treatment begins. The dose-finding portion of the study has been completed. Part B treatment dose is 400 mg twice daily.

Contact ITP Australia today to ensure your Clinical Trial is included in our register.

Platinum Sponsor

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