NCT02401061

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

A Phase 1/2, Open-Label, Dose Escalation Study of PRTX-100 in Adult Patients With Persistent/Chronic Immune Thrombocytopenia

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Protalex, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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)

Conditions

• Immune Thrombocytopenia

Interventions

Type	Name	Description
DRUG	PRTX-100	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.

Timeline

• Start date: 2015-09-01
• Primary completion: 2019-03-01
• Completion: 2019-06-04
• First posted: 2015-03-27
• Last updated: 2019-07-05

Locations

11 sites across 2 countries: United States, United Kingdom