Clinical Trial: Safety and Efficacy Study of PG2 to Treat Idiopathic Thrombocytopenic Purpura (ITP) Patients

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

Official Title: The Clinical Trial of PG2 in Subjects With Chronic Idiopathic Thrombocytopenic Purpura (ITP)

Brief Summary: This was a phase II multi-center, randomized, open-label study with two parallel study groups to evaluate the efficacy and safety of PG2 in ITP patients.

Detailed Summary: The primary objective of this exploratory study is to evaluate the efficacy of PG2 in raising the platelet counts in ITP patients using two dosing schedules. The secondary objective is to determine the safety of PG2 treatment among these patients.
Sponsor: PhytoHealth Corporation

Current Primary Outcome: Platelet Response [ Time Frame: 17 weeks ]

Original Primary Outcome: Platelet Response [ Time Frame: 6 weeks ]

Current Secondary Outcome:

  • The total number of bleeding events Grade 2 or higher for each subject during the treatment period, or till the time of end-of-study visit for early withdrawal patients [ Time Frame: 17 weeks ]
  • The subject incidence of requiring rescue therapy during the treatment period [ Time Frame: 17 weeks ]
  • The endogenous TPO and anti-platelet antibody levels [ Time Frame: 17 weeks ]
  • Patient's fatigue status (measured by the Brief Fatigue Inventory) [ Time Frame: 17 weeks ]
  • Patient's Bleeding Score (measured by the WHO Bleeding Scale) [ Time Frame: 17 weeks ]


Original Secondary Outcome:

  • The total number of bleeding events Grade 2 or higher for each subject during the treatment period, or till the time of end-of-study visit for early withdrawal patients [ Time Frame: 6 weeks ]
  • The subject incidence of requiring rescue therapy during the treatment period [ Time Frame: 6 weeks ]
  • The endogenous TPO and anti-platelet antibody levels [ Time Frame: 6 weeks ]
  • Patient's fatigue status (measured by the Brief Fatigue Inventory) [ Time Frame: 6 weeks ]
  • Patient's Bleeding Score (measured by the WHO Bleeding Scale) [ Time Frame: 6 weeks ]


Information By: PhytoHealth Corporation

Dates:
Date Received: March 10, 2009
Date Started: September 2008
Date Completion:
Last Updated: November 3, 2015
Last Verified: December 2012