Clinical Trial: A Study to Find How Safe and Effective GAMMAPLEX® is in Subjects With Chronic Idiopathic Thrombocytopenic Purpura (ITP)

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

Official Title: A Phase III, Multicenter, Open-Label Study To Evaluate the Efficacy and Safety of GAMMAPLEX® in Chronic Idiopathic Thrombocytopenic Purpura

Brief Summary: To determine if GAMMAPLEX raises the platelet count of subjects with chronic ITP to a threshold of 50 x 109/L, similar to that of published response >60%. Also to assess the safety of GAMMAPLEX and determine if platelet counts are maintained at 50 x 109/L in subjects with chronic ITP for.

Detailed Summary: The primary objective is to determine if BPL's GAMMAPLEX raises the platelet count of subjects with chronic ITP to a threshold of 50 x 109/L, similar to that of published response >60%. The secondary objectives are: 1) to determine the safety of GAMMAPLEX at the dosage used in this study. 2) to determine if GAMMAPLEX maintains platelet counts of ³ 50 x 109/L in subjects with chronic ITP for a period of time similar to that of a published data.
Sponsor: Bio Products Laboratory

Current Primary Outcome: The Number of Subjects With Chronic ITP Treated With Gammaplex Whose Platelet Count Reached a Threshold of 50 x 10^9/L. [ Time Frame: 9 days ]

The number of subjects with chronic ITP treated following treatment with Gammaplex who attained a platelet count of ≥ 50 x 10^9/L by Day 9.


Original Primary Outcome: The primary objective is to determine if BPL's GAMMAPLEX raises the platelet count of subjects with chronic ITP to a threshold of 50 x 109/L, similar to that of a historical control.

Current Secondary Outcome:

  • The Safety of GAMMAPLEX at the Dosage Used in This Study. [ Time Frame: AEs were documented from the date the informed consent form was signed until the End of Study visit on Day 90. ]

    The safety variables used to assess safety were the following:

    • Adverse events

      • The number and percent of infusions with at least 1 adverse event(AE) that occurs during an infusion or within 72 hours after the infusion stops
      • Nature, severity, and frequency of AEs
      • Suspected unexpected serious adverse reactions (SUSARs)
    • Vital signs
    • Clinical laboratory tests and Direct Coombs' Test
    • Transmission of viruses
    • Physical examination
  • Duration of Time That the Platelet Count of Subjects With Chronic ITP Treated With Gammaplex Remained ≥ 50 x 10^9/L. [ Time Frame: Days 1, 2, 3, 5, 9, 14, 21, 32. ]
    Blood samples were collected to measure platelet counts and the duration of time for which the platelet count remained ≥50 x 10^9/L was measured.


Original Secondary Outcome: To determine the safety of GAMMAPLEX at the dosage used in this study and to determine if GAMMAPLEX maintains platelet counts of ³ 50 x 109/L in subjects with chronic ITP for a period of time similar to that of a historical control.

Information By: Bio Products Laboratory

Dates:
Date Received: July 18, 2007
Date Started: September 2007
Date Completion:
Last Updated: February 26, 2013
Last Verified: February 2013