Clinical Trial: IdeS in Asymptomatic Asymptomatic Antibody-Mediated Thrombotic Thrombocytopenic Purpura (TTP) Patients
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: A Phase II Pilot Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacodynamics and Pharmacokinetics of IdeS in Asymptomatic Antibody-Mediated Thrombotic Thrombocytopenic
Brief Summary: The main purpose of this study is to evaluate safety and tolerability in patients diagnosed with asymptomatic antibody-mediated TTP with low ADAMTS13 activity after receiving single intravenous dose of IdeS.
Detailed Summary:
Immunoglobulin G-degrading enzyme of Streptococcus pyogenes (IdeS) is an IgG specific endopeptidase which cleaves IgG molecules and efficiently neutralizes Fc-mediated activities. IdeS-mediated IgG degradation constitutes a novel therapeutic principle for the treatment of IgG-driven human diseases.
In addition to assessing the safety and tolerability of IdeS the study will also assess the efficacy of IdeS to significantly increase the ADAMTS13 activity and decrease the anti-ADAMTS13 antibody levels in patients diagnosed with asymptomatic antibody-mediated TTP with low ADAMTS13 activity.
Sponsor: Hansa Medical AB
Current Primary Outcome: Safety and tolerability as measured by type, frequency and intensity of adverse events and change from baseline in parameters of clinical laboratory tests, vital signs and ECGs [ Time Frame: From dosing until end of follow up on day 64 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change from baseline in ADAMTS13 activity [ Time Frame: From day of dosing until end of follow up on day 64 ]
- Change from baseline in ADAMTS13 antibody levels (IgG and F(ab')2) [ Time Frame: From day of dosing until end of follow up on day 64 ]
- Time for ADAMTS13 activity to return to normal levels [ Time Frame: From day of dosing until end of follow up on day 64 ]
- Serum concentration of IdeS [ Time Frame: From day of dosing until day 14 ]
- Change from baseline in pharmacodynamics as measured by level of IgG [ Time Frame: From day of dosing until end of follow up on day 64 ]
- Change from baseline in pharmacodynamics as measured by level of F(ab')2 fragments [ Time Frame: From day of dosing until end of follow up on day 64 ]
- Immunogenicity of IdeS by measuring anti-drug antibodies [ Time Frame: From day of dosing until end of follow up on day 64 ]
Original Secondary Outcome: Same as current
Information By: Hansa Medical AB
Dates:
Date Received: July 27, 2016
Date Started: September 2016
Date Completion:
Last Updated: February 22, 2017
Last Verified: February 2017