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CTRI Number  CTRI/2009/091/000860 [Registered on: 22/10/2009]
Last Modified On: 12/12/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study
Modification(s)  		 Biological 
Study Design  Single Arm Study 
Public Title of Study
Modification(s)  		 Clinical trial to assess the safety and the efficacy of a new intravenous immune globulin (IGIV3I Grifols10%) in patients with idiopathic (immune) thrombocytopenic purpura. 
Scientific Title of Study
Modification(s)  		 A multi-center, prospective, open-label, clinical trial to assess the safety and the efficacy of a new intravenous immune globulin (IGIV3I Grifols 10%) in patients with idiopathic (immune) thrombocytopenic purpura. 
Trial Acronym  Nil 
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
NCT00511147  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr Viral Shah 
Designation  Medical Director 
Affiliation  Spectrum Clinical Research Pvt. Ltd. 
Address  Spectrum clinical Research Pvt. Ltd.
401, Kshamalaya Building, 4th Floor, 37 New Marine Lines
Mumbai
MAHARASHTRA
400020
India 
Phone  02240645101  
Fax  02266155567  
Email  vshah@spectrumcr.com  
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Dr Viral Shah 
Designation  Medical Director 
Affiliation  Spectrum clinical Research Pvt. Ltd. 
Address  Spectrum clinical Research Pvt. Ltd.
401, Kshamalaya Building, 4th Floor, 37 New Marine Lines
Mumbai
MAHARASHTRA
400020
India 
Phone  02240645101  
Fax  02266155567  
Email  vshah@spectrumcr.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Dr Viral Shah 
Designation  Medical Director 
Affiliation  Spectrum Clinical Research Pvt. Ltd. 
Address  Spectrum clinical Research Pvt. Ltd.
401, Kshamalaya Building, 4th Floor, 37 New Marine Lines
Mumbai
MAHARASHTRA
400020
India 
Phone  02240645101  
Fax  02266155567  
Email  vshah@spectrumcr.com  
 
Source of Monetary or Material Support
Modification(s)  
Instituto Grifols, S.A. Barcelona , Spain 
 
Primary Sponsor
Modification(s)  
Name  Spectrum Clinical Research Pvt Ltd  
Address  401, 4th Floor Kshamalaya Building, 37 New marine Lines , Mumbai - 400020. 
Type of Sponsor  Contract research organization 
 
Details of Secondary Sponsor
Modification(s)  
Name  Address 
CROfessionals LLC   6593 Merchant Place, Suite 200 Warrenton, VA 20187 
 
Countries of Recruitment     India
Canada
United States of America  
Sites of Study
Modification(s)  
No of Sites = 11  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jayanti Patel  Apple Hospital  Udhana Darwaja,Ring Road
Surat
GUJARAT 		 02616696000

drpranavthaker@gmail.com 
Dr Arpit Jain  Artemis Health Institute,  Sector-51
Gurgaon
HARYANA 		 01246767010
01246767708
arpit@artemishealthsciences.com 
Dr Joseph John  Christian Medical College  Clinical Haematology & Haemato-Oncology Unit, Dept. of Medicine
Ludhiana
PUNJAB 		 01615037957
01612600270
mjosephjohn@gmail.com 
Dr Vikram Mathew  Christian Medical College  Dept. Of Haematology,CMC, IDA Scudder Road
Vellore
TAMIL NADU 		 04162282352
04162226449
haemres@cmcvellore.ac.in 
Dr Jayant Indurkar  Kodlikeri Memorial Hospital  8 Manjit Nagar,Opp. Akashwani Jalna Road
Aurangabad
BIHAR 		 02402335751
02402359279
jayantindurkar@yahoo.co.in 
Dr Sharat Damodar  Narayana Hrudayalaya,   No.258/A,bommasandra Industrial Area, Anekal Taluk
Bangalore
KARNATAKA 		 08027835000
08027835208
drsharat.damodar@gmail.com 
Dr Ashis Mukhopadhyay  Netaji Subhash Chandra Bose Cancer Research Institute  Clinical Research Department, 16A, Park lane
Kolkata
WEST BENGAL 		 03322291049
03322295628
somashis@vsnl.net 
Dr Vijaya Ramanan  Ruby Hall Clinic  New Cancer Centre,40, Sasoon Road
Pune
MAHARASHTRA 		 02066455605
02066455605
mvijayr@gmail.com 
Dr Shashikant Apte  Sahyadri hospital  30C, Erandwane,Karve Road
Pune
MAHARASHTRA 		 02025403000
02025459117
shashikant.apte@gmail.com 
Dr Chirag A Shah  Shalby Hospital  Opp. Karnavati Club, S.G. Road,P.O Ambawadi Vistar
Ahmadabad
GUJARAT 		 07940203148
07940203115
research1@shalby.org 
Dr Cecil Ross  St. Johns Medical College Hospital  Sarjapur road
Bangalore
KARNATAKA 		 08022065352
08025501144
cecilross@bsnl.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 11  
Name of Committee  Approval Status 
Artemis Health sciences IRB - Gurgaon  Approved 
ClinXXL Independent Ethics Committee, Mumbai  Approved 
CMC , Vellore , IRB  Approved 
EC Kodlikeri Hospital - Aurangabad  Approved 
EC Netaji Subhas Chandra Bose CAncer Research Istitute - Kolkata  Approved 
Erhics Committee, Shalby Hospital, Ahmedabad  Approved 
Ethical Research Commiittee - Bangalore  Approved 
Institutional EC, CMC, Ludhiana  Approved 
Institutional Ethical Review Board - Bangalore  Approved 
Poona Medical Research Foundation Ethics Commiittee, Pune  Approved 
Sahyadri Speciality Hospital EC - Pune  Approved 
 
Regulatory Clearance Status from DCGI
Modification(s)  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Chronic idiopathic (immune) thrombocytopenic purpura, (1) ICD-10 Condition: D693||Immune thrombocytopenic purpura, (2) ICD-10 Condition: D693||Immune thrombocytopenic purpura,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  Human intravenous immune globulin  IGIV3I 10% 1 g/kg/day is given on two consecutive days, Day 1 and Day 2, for a total dose of 2 g/kg over two days. 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  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. 
 
ExclusionCriteria 
Details  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.
- Any hemorrhagic event in which the subject is at risk of death at the time of the event.
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.  
 
Method of Generating Random Sequence
Modification(s)  		 Not Applicable 
Method of Concealment
Modification(s)  		 Not Applicable 
Blinding/Masking
Modification(s)  		 Open Label 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
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
Modification(s)  
Outcome  TimePoints 
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. 
 
Target Sample Size
Modification(s)  		 Total Sample Size="75"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial
Modification(s)  		 Phase 3 
Date of First Enrollment (India)
Modification(s)  		 02/04/2010 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  24/03/2008 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial
Modification(s)  		 Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Publication of data generated in the study is governed by the Investigator Clinical Trial Agreement. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  		 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. 
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