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

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)

Timeline

Start

2015-09

Primary completion

2019-03

Completion

2019-06-04

Outcome

Outcome not reported

Stopped: “Enough data has been collected to allow analysis of safety profile and risk-benefit.”

Drugs

Indications