NCT02566603

PRTX-100-203 Open-Label, Dose Escalation Study in Adult Patients With ITP

A Phase 1b 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: 15 (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.

Conditions

• Immune Thrombocytopenia

Interventions

Type	Name	Description
DRUG	PRTX-100	Four weekly infusions of PRTX-100 at a level of 3 micrograms of PRTX-100 per kilogram of patient weight, infused over 30 minutes, followed by four hours of observation after start of infusion.
DRUG	PRTX-100	Four weekly infusions of PRTX-100 at a level of 6 micrograms of PRTX-100 per kilogram of patient weight, infused over 30 to 60 minutes, followed by four hours of observation after start of infusion.
DRUG	PRTX-100	Four weekly infusions of PRTX-100 at a level of 12 micrograms of PRTX-100 per kilogram of patient weight, infused over 60 minutes, followed by four hours of observation after start of infusion.
DRUG	PRTX-100	Four weekly infusions of PRTX-100 at a level of 18 micrograms of PRTX-100 per kilogram of patient weight, infused over 60 minutes, followed by four hours of observation after start of infusion.
DRUG	PRTX-100	Four weekly infusions of PRTX-100 at a level of 24 micrograms of PRTX-100 per kilogram of patient weight, infused over 60 minutes, followed by four hours of observation after start of infusion.

Timeline

• Start date: 2015-11-01
• Primary completion: 2018-05-17
• Completion: 2018-05-17
• First posted: 2015-10-02
• Last updated: 2019-03-25

Locations

16 sites across 2 countries: France, United Kingdom