Clinical trial to assess the safety and the efficacy of a new intravenous immune globulin (IGIV3I Grifols10%) in patients with idiopathic (immune) thrombocytopenic purpura.

Phase 3

Completed

• Conditions: Immune thrombocytopenic purpura, (2) ICD-10 Condition: D693||Immune thrombocytopenic purpura,

• Registration Number: CTRI/2009/091/000860
• Lead Sponsor: Spectrum Clinical Research Pvt Ltd

Brief Summary

This study is a multi-center, prospective, open-label, clinical trial to assess the safety and the efficacy of a new intravenous immune globulin (IGIV3I Grifols10%) in patients with idiopathic (immune) thrombocytopenic purpura that will be conducted in India, USA and Canada. Globally 75 subjects will be recruited for the study . However from India 30 subjects will be recruited in study from 12 centres . Anticipated date of enrollment for the indian arm would be 1st week of December 2009. Efficacy Endpoint : -Response rate, defined by the proportion of treated patients whose platelet counts increase from ≤ 20 x 10.e9/L to ≥ 50 x 10.e9/L by Day 8 ± 1 (the day of the first infusion is Day 1). -Time to platelet count recovery, defined by the number of days elapsed from Day 1 (the day of the first infusion of the IMP) to the day when the platelet count is first known to be ≥ 50 x 10.e9/L at any moment during the clinical follow-up period ending on Day 30 ± 1. -Duration of response, defined by the number of consecutive days for which the platelet count remains ≥ 50 x 10.e9/L at any moment during the clinical follow-up period ending on Day 30 ± 1. -Regression of hemorrhage/bleedings, defined by the proportion of treated patients with hemorrhage/bleedings at Day 1 (i.e., the day of the first infusion, pre-infusion) who improve their diathesis during the clinical follow-up period ending on Day 15 ± 1. Assessment of regression is made according to a categorized rating scale defined in advance.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02-04
• Last Update Posted: 2019-12-12

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• 1.To be male or female.
• 2.To be 18 to 70 years of age.
• 3.To have a diagnosis of chronic ITP.
• 4.To have a platelet count ≤ 20 x 10.e9/L.
• 5.To sign an informed consent form.

Exclusion Criteria

• 1.Has a history or clinical evidence of medical conditions (other than ITP) felt to be the underlying cause of the thrombocytopenia.
• 2.Has a diagnosis of secondary immune thrombocytopenia.
• 3.Has a history of severe (e.g. anaphylactic) reactions to blood or any blood-derived product.
• 4.Is suffering a serious and/or life-threatening hemorrhage/bleeding defined as: -Any intracranial or central nervous system bleeding.
• 5.Is known to have IgA deficiency.
• 6.Has a documented diagnosis of thrombotic complications to polyclonal IVIG therapy in the past.
• 7.Is anemic (Hgb 9 g/dL).
• 8.Is known to have a positive test for either HIV 1/2 or HCV 9.Has a splenectomy within the prior 8 weeks to the screening visit.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary efficacy endpoint:Response rate as defined by the proportion of treated patients in whom platelet counts increase from ≤ 20 x 10.e9/L to ≥ 50 x 10.e9/L by Day 8 ± 1 [where the day of the first infusion is Day 1].	From Day 1 to Day 8 ± 1

Secondary Outcome Measures

Name	Time	Method
Time to platelet count recovery as defined by the number of days elapsed from Day 1 (the day of the first infusion of the IMP) to the day when the platelet count is first known to be 50 x 10.e9/L at any moment during the clinical follow-up period ending on Day 30 ± 1.	Day 1 to Day 30 ±1 Duration of response: from Day 1 to Day 30 ± 1 Regression of hemorrhage/bleedings: from Day 1 to Day 15 ± 1.

Trial Locations

Locations (10)

Apple Hospital; 🇮🇳 Surat, GUJARAT, India

Artemis Health Institute,; 🇮🇳 Gurgaon, HARYANA, India

Christian Medical College; 🇮🇳 Vellore, TAMIL NADU, India

Kodlikeri Memorial Hospital; 🇮🇳 Aurangabad, BIHAR, India

Narayana Hrudayalaya,; 🇮🇳 Bangalore, KARNATAKA, India

Netaji Subhash Chandra Bose Cancer Research Institute; 🇮🇳 Kolkata, WEST BENGAL, India

Ruby Hall Clinic; 🇮🇳 Pune, MAHARASHTRA, India

Sahyadri hospital; 🇮🇳 Pune, MAHARASHTRA, India

Shalby Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

St. Johns Medical College Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Apple Hospital

🇮🇳Surat, GUJARAT, India

Dr Jayanti Patel

Principal investigator

02616696000

drpranavthaker@gmail.com