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Be Part of Research - Trial Details - PRTX-100-202 Open-Label, Dose Escalation Study in Adult Patients With ITP

PRTX-100-202 Open-Label, Dose Escalation Study in Adult Patients With ITP

Stopped

Open to: ALL

Age: 18.0 - N/A

Medical Conditions

Thrombocytopenia
Purpura, Thrombocytopenic, Idiopathic


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Pre-clinical and clinical evaluations show that PRTX- 100 has biological activity that may lead to improved platelet levels where these are decreased due to immunological pathologies and that PRTX-100 has an acceptable safety profile. In vivo treatment with PRTX-100 has been shown to raise platelet counts in a mouse model of immune thrombocytopenia (ITP). The primary objective of the study is to assess the efficacy of PRTX-100 in terms of platelet response in patients with chronic/persistent ITP.

Funding Source - FDA OOPD (1R01FD005750-01A1)

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Sep 2015 Mar 2019

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Four weekly infusions of PRTX-100 at a level of 1 (3, 6,12, 18, or 24) microgram of PRTX-100 per kilogram of patient weight, infused over 30 minutes, followed by four hours of observation.

Intervention Arm Group : PRTX-100;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Queen Elizabeth Hospital
    Birmingham
    B15 2TH
  • Glasgow Royal Infirmary
    Glasgow
    G4 0SF
  • Aberdeen Royal Infirmary
    Aberdeen
    AB
    AB25 27N
  • Leicester Royal Infirmary
    Leicester
    Leichester
    LE1 5WW
  • Norfolk and Norwich Hospital
    Norwich
    NR4 7UY


The study is sponsored by Protalex, Inc.




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Read full details for Trial ID: NCT02401061
Last updated 02 July 2019

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