Clinical trials listed for ITP are a starting point for discussion with a healthcare professional. Be sure you understand all the implications of the proposed treatment by reading the informed consent very carefully and speaking with your doctor before enrolling in a clinical trial.
What are Clinical Trials?
Clinical Trials are controlled patient studies that must be performed before a new drug or treatment is approved by the Food and Drug Administration (FDA) in the United States and similar organizations in other countries. Clinical trials are also completed after a drug or treatment is approved to document the effectiveness of the treatment, or to gain approval to use the drug or therapy for a different disease or age group.
There are three main phases to clinical trials, completed in sequence. A Phase I study tests the safety and side effects of the drug. A Phase II study is initiated to determine the efficacy of the drug, to see if it works as anticipated. And, a Phase III study tests the efficacy of drug or treatment and documents the side effects in a large population of volunteers.
Finding a Clinical Trial
The best way to find the latest information on clinical trials is by visiting ClinicalTrials.gov, a database of privately and publicly funded clinical studies conducted around the world. Pharmaceutical companies and researchers update this site frequently to ensure it contains the most comprehensive and up-to-date clinical trial listings. The database features an easy-to-use search facility and detailed guidance for patients and industry.
Featured Clinical Trials
VAYHIT1 - A phase 3, randomized, double-blind study of ianalumab (VAY736) versus placebo in addition to first-line corticosteroids in primary immune thrombocytopenia (ITP)
The VAYHIT1 study is enrolling adult patients (≥ 18 years) with newly diagnosed primary ITP within the last 3 months. Patients should have a platelet count below 30G/L before starting first-line corticosteroids and should have a platelet count ≥ 50G/L on corticosteroids treatment anytime prior to study randomization. Patients enrolled in the study are randomized to receive either ianalumab higher dose or ianalumab lower dose or placebo. The purpose of the study is to assess if the addition of ianalumab to first-line standard of care with corticosteroids can help to maintain a platelet count ≥ 30G/L without the need for rescue treatment or a new ITP therapy, and to prolong the time to treatment failure in adults with primary ITP.
HUTCHMED is conducting a clinical trial currently enrolling adult patients who were diagnosed with ITP at least 3 months ago, and have had intolerance, insufficient response, or recurrence after at least 1 anti-ITP standard drug therapy. Patients must have a platelet count less than 30,000 µL for at least 2 visits during the screening period and no platelet count >35,000 µL in the 2 weeks before enrollment.
The purpose of the study is to evaluate the safety, tolerability, and efficacy of HMPL-523 in adult patients with ITP. HMPL-523 is a selective Syk inhibitor, which acts by inhibition of B-cell production of antiplatelet antibodies, and subsequent destruction of autoantibody-coated platelets by macrophages. Patients will receive HMPL-523 tablets to be taken once daily for 24 weeks. Patients will be enrolled across dose levels to allow adequate assessment of safety and preliminary efficacy of HMPL-523.
VAYHIT2 -A phase 3 randomized, double-blind study of ianalumab (VAY736) versus placebo in addition to eltrombopag in patients with primary immune thrombocytopenia (ITP) who had an insufficient response or relapsed after first line steroid treatment
The VAYHIT2 study is enrolling patients with the diagnosis of primary ITP who require second-line therapy with a TPO-RA and are eligible to receive eltrombopag. Patients enrolled in the study are randomized to receive either ianalumab higher dose or ianalumab lower dose or placebo, in addition to eltrombopag. The purpose of the study is to assess if the addition of ianalumab to eltrombopag can significantly improve the long-term outcome by prolonging time to treatment failure in adults with primary ITP compared to eltrombopag monotherapy. Ianalumab binds to the B cell Activating Factor (BAFF) receptor, blocking and depleting B-cells, which have a fundamental role in the increased peripheral destruction of platelets.
List of Clinical Trials:
(Select from the list below)- Clinical Trials Actively Recruiting in the USA
- Clinical Trials Actively Recruiting in Canada
- Clinical Trials Actively Recruiting Internationally
- Clinical Trials Active But Not Recruiting
- Completed Clinical Trials
- Clinical Trials for Other Platelet Disorders
- Clinical Trials Not Yet Recruiting
Please contact PDSA if you find missing or incorrect information regarding any of the clinical trials listed.