IMPORTANT!
This summary of clinical trials for ITP is intended to be used as a starting point for discussion with a health care professional. Be sure you understand all the implications of the proposed treatment and read the informed consent very carefully 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 FDA. They are also done after a drug or treatment is approved to document the effectiveness of the treatment or to gain FDA approval to use the drug or therapy to treat a different disease.

There are three main phases to clinical trials, done 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. A Phase III study tests the results on a large population of volunteers.

 

Clinical Trials List

A Study to Investigate the Efficacy and Safety of S-888711 Tablets Administered to Adult Subjects With Immune Thrombocytopenia
S-888711 is a TPO mimetic for thrombocytopenia, from Shionogi USA, Inc.

Safety and Efficacy Study of PG2 to Treat Idiopathic Thrombocytopenic Purpura (ITP) Patients
PG2 is a biologic from PhytoHealth Corporation, based in Taiwan.

Efficacy and Safety Study of Eltrombopag in Pediatric Patients With Thrombocytopenia From Chronic ITP (PETIT)
Eltrombopag, from GlaxoSmithKline, is a small molecule (pill) that stimulates the bone marrow to make more platelets.

The Efficacy of Dexamethasone Versus Dexamethasone Combined With Rituximab in Patients With Newly Diagnosed Idiopathic Thrombocytopenic Purpura (ITP)
Dexamethasone, a type of corticosteroid, and rituximab, a biologic that disables part of the immune system, are often used separately to treat ITP.  The study sponsor is Copenhagen University Hospital.

A Prospective, Study Evaluating Changes in Bone Marrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment of Thrombocytopenia Associated With Immune (Idiopathic) Thrombocytopenia Purpura (ITP)
Romiplostim is a biologic from Amgen that stimulates the bone marrow to make more platelets.

A Phase 1, Open-Label, Multiple-Dose, Dose Escalation Study of the Safety and Tolerability of Staphylococcal Protein A in Adult Patients With Chronic Idiopathic Thrombocytopenic Purpura (ITP)
Staphylococcal protein A (PRTX-100) is a biologic made by Protalex.

IGIV Study for Chronic ITP Patients Ages 3-70
1. http://www.clinicaltrials.gov/ct2/show/NCT00511147
2. http://www.clinicaltrials.gov/ct2/show/NCT00699140
This is a study using a specific brand of IGIV, IGIV3I 10% by Grifols Biologicals Inc. IGIV is also called IGg or IVIg.



A Study to Find How Safe and Effective GAMMAPLEX® is in Subjects With Chronic Idiopathic Thrombocytopenic Purpura (ITP)
This study uses Gammaplex, a brand of IVIg from Bio Products Laboratory.

A Randomized Study of IVIG vs. IVIG With High Dose Methylprednisolone in Childhood ITP
This study is sponsored by the Hospital for Sick Children in Canada in collaboration with Bayer.

Open Label Trial on the Safety and Efficacy of Sym001 in the Treatment of Immune Thrombocytopenic Purpura (ITP)

• Sym001, a new type of anti-D, is being tested by Symphogen A/S in collaboration with Biovitrum.

An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects With ITP
Subjects in this study will inject themselves with romiplostim, a biologic from Amgen that stimulates the bone marrow to make more platelets.

Pilot Study of Rituximab for the Treatment of Acute Immune Thrombocytopenic Purpura (ITP)
Sponsored by Hamilton Health Sciences and McMaster University in Canada in conjunction with Hoffmann-LaRoche.

 

 

Study of Veltuzumab (hA20) at Different Doses in Patients With ITP
Veltuzumab (hA20) is a biologic by Immunomedics, Inc.that is similar to rituximab.

 

Prednisone or Dexamethasone in Treating Patients With Newly Diagnosed, Previously Untreated Primary Immune Thrombocytopenic Purpura
Prednisone and dexamethasone are types of corticosteroids.

 

Sirolimus for Autoimmune Disease of Blood Cells
Sirolimus, also known as rapamycin, removes white blood cells from circulation and is used to prevent rejection after organ transplants.

Problems with Platelet Formation

This study is being conducted by the National Institutes of Health.   The purpose of the study is to determine how platelet sacs are formed and what happens to cause bleeding disorders.  They are looking for people diagnosed with Gray Platelet Syndrome (GPS), Hermansky-Pudlak Syndrome (HPS), Storage Pool Deficiency (SPD), Chediak-Higashi Syndrome (CHS), Griscelli Syndrome (GS), Wiscott-Aldrich Syndrome (WAS), Thrombocytopenia Absent Radius Syndrome (TAR)  Call 1-800-411-1222 for more information.

See http://clinicalstudies.info.nih.gov/detail/A_2004-HG-0226.html