Clinical Trial: This Clinical Study is to Test Efficacy and Safety of BT595 in Chronic Primary Immune Thrombocytopenia (ITP)

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

Official Title: An Open Label, Prospective, Randomized, Multicenter Study Investigating Clinical Efficacy and Safety of the Human Normal Immunoglobulin for Intravenous Administration BT595 in Patients With Chronic Pr

Brief Summary: The main purpose of this study is to assess the efficacy and safety of BT595 in adult subjects with chronic ITP. The primary objective of this study is to determine the rate of subjects with a response. A response is defined as a platelet count of ≥30×10^9/L and at least a 2 fold increase of the baseline count, confirmed on at least 2 separate occasions at least 7 days apart, and the absence of bleeding. The secondary objectives of this study, in addition to further efficacy assessments, are to evaluate the safety of BT595.

Detailed Summary:
Sponsor: Biotest

Current Primary Outcome: Rate of subjects with response (R) [ Time Frame: 1 month ]

The rate of subjects with response is defined as subjects with a platelet count of ≥30×10^9/L and at least a 2 fold increase of the baseline count, confirmed on at least 2 separate occasions at least 7 days apart, and the absence of bleeding


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The number of subjects with complete response (CR) [ Time Frame: 1 month ]
    The number of subjects with CR, which is defined as a platelet count ≥100×10^9/L, confirmed on at least 2 separate occasions at least 7 days apart, and the absence of bleeding
  • The percentage of subjects with complete response (CR) [ Time Frame: 1 month ]
    The percentage of subjects with CR, which is defined as a platelet count ≥100×10^9/L, confirmed on at least 2 separate occasions at least 7 days apart, and the absence of bleeding
  • The number of subjects with no response (NR) [ Time Frame: 1 month ]
    The number of subjects with NR, which is defined as subjects without R, i.e. a platelet count <30×10^9/L or less than a 2 fold increase of baseline platelet count, confirmed on at least 2 separate occasions, approximately 1 day apart, or bleeding
  • The percentage of subjects with no response (NR) [ Time Frame: 1 month ]
    The percentage of subjects with NR, which is defined as subjects without R, i.e. a platelet count <30×10^9/L or less than a 2 fold increase of baseline platelet count, confirmed on at least 2 separate occasions, approximately 1 day apart, or bleeding
  • The number of subjects with a loss of response [ Time Frame: 1 month ]
    The number of subjects with a loss of response (only in subjects who previously had CR or R), which is defined as a platelet count <100×10^9/L or bleeding (from CR) or platelet count <30×10^9/L or less than 2 fold increase of the baseline platelet count, or bleeding (from R). Platelet counts will be confirmed on at least 2 separate occasions approximately 1 day apart
  • The percentage of subjects with a loss of response [ Time Frame: 1 month ]
    The percentage of subjects with a loss of response (only in subjects who previously had CR or R), which is defined as a platelet count <100×10^9/L or bleeding (from CR) or platelet count <30×10^9/L or less than 2 fold increase of the baseline platelet count, or bleeding (from R). Platelet counts will be confirmed on at least 2 separate occasions approximately 1 day apart
  • Time to Response (R) [ Time Frame: 1 month ]
    Time to response (R), which is defined as the time from the start of treatment to the time of achievement of CR or R
  • Duration of response (R), [ Time Frame: 1 month ]
    Duration of response (R), which is defined as the time from the achievement of CR or R to loss of CR or R
  • The number of subjects with response to ≥50×10^9/L [ Time Frame: 1 month ]
    The number of subjects with response to ≥50×10^9/L, which is defined as a platelet count increase to at least ≥50×10^9/L within 7 days of the first BT595 infusion
  • The percentage of subjects with response to ≥50×10^9/L [ Time Frame: 1 month ]
    The percentage of subjects with response to ≥50×10^9/L, which is defined as a platelet count increase to at least ≥50×10^9/L within 7 days of the first BT595 infusion
  • Subject's maximum platelet count achieved [ Time Frame: 1 month ]
  • Time to subject's maximum platelet count [ Time Frame: 1 month ]
  • Time course of platelet count [ Time Frame: 1 month ]
  • Occurrence of bleeding symptoms [ Time Frame: 1 month ]


Original Secondary Outcome: Same as current

Information By: Biotest

Dates:
Date Received: July 25, 2016
Date Started: November 2016
Date Completion: February 2018
Last Updated: April 3, 2017
Last Verified: April 2017