PRTX-100 in ITP (PRTX-100-202)
Research type
Research Study
Full title
A Phase 1/2 Open-Label, Dose Escalation Study of PRTX-100 in Adult Patients with Persistent/Chronic Immune Thrombocytopenia (PRTX-100-202)
IRAS ID
235483
Contact name
Henry Watson
Contact email
Sponsor organisation
Protalex Inc
Eudract number
2017-003537-28
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 7 months, 30 days
Research summary
Immune thrombocytopenia (ITP) is a disease where patients have a low platelet count in their blood with normal bone marrow. It causes a characteristic rash and an increased tendency to bleed. It can often occur after an infection and usually resolves itself within two months. Persistent or chronic persists longer than six months with a specific cause being unknown.
Despite the availability of a variety of therapy options, the overall success of Immune Thrombocytopenia (ITP) treatment is limited, often requiring repeated lines of treatment in patients with chronic ITP. Many of the current treatments also suppress immune function which can leave patients at risk of infection. The current treatments have side effects known to reduce an ITP patient’s quality of life, or require frequent treatment (daily, weekly) to maintain responses. This study will explore the safety of up to 6 dose levels of PRTX-100 and assess the efficacy (how well it works) of (IV) PRTX-100 to platelet response. A 7th group of up to 12 patients will be treated after the initial 6 groups of patients have been treated. They will receive a dose of study drug that will be determined by the results of the initial 6 groups.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
17/EM/0406
Date of REC Opinion
12 Dec 2017
REC opinion
Further Information Favourable Opinion