Clinical Trial: Study to Assess Efficacy and Safety of Anti-von Willebrand Factor Nanobody in Patients With Acquired Thrombotic Thrombocytopenic Purpura (TTP)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase II, Single-blind, Randomised, Placebo-controlled Trial to Study the Efficacy and Safety of Anti-von Willebrand Factor Nanobody Administered as Adjunctive Treatment to Patients With Acquired

Brief Summary: The purpose of this study is to determine whether anti-von Willebrand factor Nanobody is safe and effective as adjunctive treatment in patients with acquired thrombotic thrombocytopenic purpura (TTP). Patients will receive either placebo or anti-von Willebrand factor Nanobody as adjunctive therapy to plasma exchange.

Detailed Summary:
Sponsor: Ablynx

Current Primary Outcome: Reduction of time-to-recovery [ Time Frame: after completion of plasma exchange, followed by confirmation 48h later ]

Reduction of time-to-recovery, defined by the achievement of laboratory blood marker response (platelet count and LDH level), confirmed at 48 hours after the initial reporting of this response


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Reduction of number of relapses [ Time Frame: 12 months ]
    Number of patients relapsing of TTP (de novo event of TTP that occurs later than 30 days after the last daily plasma exchange) for a maximum of 1 year, and time to first relapse of TTP
  • Reduction of number of exacerbations [ Time Frame: 30 days after the last daily plasma exchange session ]
    Number of exacerbations of TTP, and time to first exacerbation of TTP


Original Secondary Outcome:

  • Reduction of number of relapses [ Time Frame: 12 months ]
    Number of patients relapsing of TTP (de novo event of TTP that occurs later than 30 days after the last plasma exchange) for a maximum of 1 year, and time to first relapse of TTP
  • Reduction of number of exacerbations [ Time Frame: 30 days after the last plasma exchange session ]
    Number of exacerbations of TTP, and time to first exacerbation of TTP


Information By: Ablynx

Dates:
Date Received: June 25, 2010
Date Started: September 2010
Date Completion:
Last Updated: July 22, 2015
Last Verified: June 2015