Clinical Trial: Phase 2 Safety and Efficacy Study of RA101495 to Treat PNH Patients

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Phase 2 Multicenter, Open-Label, Uncontrolled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of RA101495 in Subjects With Paroxysmal

Brief Summary: The purpose of the study is to evaluate the safety and efficacy of RA101495 in patients with Paroxysmal Nocturnal Hemoglobinuria (PNH). There will be two groups of patients in the study: the first group will include patients who have never received eculizumab for treatment of PNH. The second group will include patients who have received treatment with eculizumab for at least 6 months prior to the study. Patients will be treated with RA101495 for 12 weeks.

Detailed Summary:
Sponsor: Ra Pharmaceuticals

Current Primary Outcome: Change-from-baseline in serum lactate dehydrogenase (LDH) level. [ Time Frame: Through Week 12 of the study ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Ra Pharmaceuticals

Dates:
Date Received: March 8, 2017
Date Started: March 2017
Date Completion: February 2018
Last Updated: March 8, 2017
Last Verified: March 2017