Clinical Trial: An Open Phase 3 Study of IV-Globulin SN Inj.10% to Treat Immune Thrombocytopenia

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

Official Title: Prospective, Non-Randomized, Open-label, Single-arm, Multi-Center Phase III Clinical Trial to Evaluate the Efficacy and Safety of IV-Globulin SN Inj.10% in the Patients Diagnosed With Same as current

Current Secondary Outcome:

• Duration from the achievement of platelet count ≥ 50 x 10^9/L increase to the loss [ Time Frame: 4 weeks after intervention ]
• % patient with response [ Time Frame: 4 weeks after intervention ]
  Response (R): platelet count ≥ 30 x 10^9/L and at least 2-fold increase of the baseline count, confirmed on at least 2 separate occasions at least 7 days apart, and absence of bleeding.
• % patient with complete response [ Time Frame: 4 weeks after intervention ]
  Complete response (CR): platelet count >100 x 10^9/L, confirmed on at least 2 separate occasions at least 7 days apart, and absence of bleeding.
• Duration of response [ Time Frame: 4 weeks after intervention ]
  measured from the achievement of R to loss of R
• Duration of complete response [ Time Frame: 4 weeks after intervention ]
  measured from the achievement of CR to loss of CR
• % patient with no response [ Time Frame: 4 weeks after intervention ]
  No response (NR): platelet count < 30 x 10^9/l or less than 2-fold increase of baseline platelet count, confirmed on at least 2 separate occasions approximately 1 day apart, or bleeding.
• Descriptive statistics of platelet count at each visit [ Time Frame: 4 weeks after intervention ]
• Haemorrhage severity rate at each visit [ Time Frame: 4 weeks after intervention ]
  Haemorrhage severity score (HSS) system
• Quality of Life (EQ-5D) [ Time Frame: 4 weeks after intevention ]
• Patient reported bleeding events [ Time Frame: 12 weeks after intervention ]
• Usage of rescue mediations [ Time Frame: 4 weeks after intervention ]
  Rescue medications: Acetaminophen, antihistamines.
• Adverse events [ Time Frame: 12 weeks after intervention ]
• Drug compliance [ Time Frame: 2 days of intervention ]
• Viral safety [ Time Frame: Base line, 4 weeks and 12 weeks after intervention ]
• Time to the achievement of platelet count ≥50x10^9/L increase [ Time Frame: within 7 days after intervention ]

Original Secondary Outcome: Same as current

Information By: Green Cross Corporation

Dates:
Date Received: February 13, 2014
Date Started: June 2014
Date Completion:
Last Updated: May 23, 2016
Last Verified: May 2016