CTRI/2011/11/002098 [Registered on: 01/11/2011] Trial Registered Prospectively
Last Modified On:
25/04/2013
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Biological
Study Design
Single Arm Study
Public Title of Study
A clinical study to evaluate the efficacy and safety of immunoglobulin intravenous (human) 10% (NewGam) in Primary Immune Thrombocytopenia, Is the condition of having an abnormally low platelet count (thrombocytopenia) of no known cause.
Scientific Title of Study
A Prospective, open-label, non-controlled, multicenter, phase III clinical study to evaluate the efficacy and safety of immunoglobulin intravenous (human) 10% (NewGam) in
Primary Immune Thrombocytopenia
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
2009-014589-24
EudraCT
NGAM-02
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Max Neeman Internatinal, Max House, 1st Floor,1, Dr. Jha Marg, Okhla Phase-III, New Delhi-110020
South DELHI 110020 India
Phone
91-9717287654
Fax
91-011-41001945
Email
atulg@neemanasia.com
Details of Contact Person Public Query
Name
Dr Shariq Anwar
Designation
Director- Operations
Affiliation
Max Neeman International
Address
Max Neeman International
Max House, 1, Dr. Jha Marg, Okhla Phase-III
City: New Delhi
State: New Delhi
Postal Code: 110020
Country: India
South DELHI 110020 India
Phone
91-9810979215
Fax
91-11-40548168
Email
sanwar@neemanasia.com
Source of Monetary or Material Support
OCTAPHARMA AG
Seidenstrasse 2
CH-8853 Lachen, Switzerland
Primary Sponsor
Name
OCTAPHARMA AG
Address
Seidenstrasse 2
CH-8853 Lachen, Switzerland
Type of Sponsor
Pharmaceutical industry-Global
Details of Secondary Sponsor
Name
Address
Max Neeman International
Max House,1st Floor
1 Dr. Jha Marg, Okhla III
New Delhi- 110020
Countries of Recruitment
Czech Republic Germany India Poland Romania
Sites of Study
No of Sites = 4
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Shailesh Singi
CARE Hospital The Institute of Medical Sciences
Hematologist and Hemato-oncologist
CARE Hospital
The Institute of Medical Sciences
Banjara Hills road no 1
City: Hyderabad
State: Andhra Pradesh
Postal Code: 500034
Country: India Hyderabad ANDHRA PRADESH
91-40-30418422 91-40-23300795 drsrs74@yahoo.com
Dr Suthanthira Kannan
G Kuppuswamy Naidu Memorial Hospital
Consultant Hematologist
G Kuppuswamy Naidu Memorial Hospital,
6237, Netaji Road, Pappanakkenpalayam
City: Coimbatore
State: Tamil Nadu Postal Code: 641030
Country: India Coimbatore TAMIL NADU
Onco Hematologist
Jehangir Clinical Development Centre Pvt. Ltd.,
Jehangir Hospital Premises , 32 , Sassoon Road ,
City: Pune
State: Maharashtra Postal Code: 411001
Country: India Pune MAHARASHTRA
91-20-67268800 91-20-26059319 mvijayr@gmail.com
Dr Shashikant Apte
Sahyadri Speciality Hospital
Head, Dept of Hematology and BMT Unit
Sahyadri Speciality Hospital, 30C, Erandawane, Karve Road
City: Pune
State: Maharashtra Postal Code: 411 004
Country: India Pune MAHARASHTRA
Care Foundation, Institutional Ethics Committee The Institute of Medical Sciences Banjara Hills road no 1 Hyderabad – 500034
Approved
G. Kuppuswamy Naidu Memorial Hospital,Netaji Road, Coimbatore-641030, Tamil Naidu.
Approved
Hirabhai Cowasji Jehangir Medical Research Institute & Jehangir Clinical Development Centre, Institutional Ethics Committee Jehangir Hospital, 32, Sassoon Road, Pune 411001
Approved
Sahyadri Hospitals Ltd. Ethics Committee, Sahyadri Speciality Hospital, 30 C, Erandwane, Karve Road, Pune 411004, Maharashtra, India.
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
Primary Immune Thrombocytopenia (ITP),
Intervention / Comparator Agent
Type
Name
Details
Intervention
Intervention Agent: NewGam, (human normal immunoglobulin)
InterVention Agent: NewGam, (human normal immunoglobulin) 10%, solvent/detergent (S/D) treated solution for intravenous infusion. Daily dose of 1 g/kg given for two consecutive days, for a total of 2 g/kg
1. Age of ≥18 years and ≤65 years.
2. Confirmed diagnosis of chronic primary ITP (threshold platelet count less than 100x109/L) of at least 12 months duration and fulfilling the following criteria:
a) history and physical examination excluding other causes of thrombocytopenia b) pattern of bleeding associated with platelet disorders using the verbal rating scale according to Buchanan (2002) [8].
c) isolated thrombocytopenia in the blood count; apart from thrombocytopenia, the blood count is normal for the patient’s age, or if abnormal, readily explained
d) peripheral blood smear consistent with ITP: thrombocytopenia with platelets of normal size or slightly larger than normal, with absence of platelet clumps and giant platelets; normal red and white blood cell morphology
e) when any abnormal finding is present, additional diagnostic evaluation exclude other causes of thrombocytopenia.
3. Platelet count of ≤20x109/L with or without bleeding manifestations.
4. Freely given written informed consent from patient.
5. Women of childbearing potential must have a negative result on a pregnancy test (human chorionic gonadotropine [HCG]-based assay) and need to practice contraception using a method of proven reliability for the duration of the study.
Note:"In India as per the DCGI cap we will include patients from the age of 18 to 65 yrsâ€
ExclusionCriteria
Details
1. Thrombocytopenia secondary to other diseases (such as Acquired Immunodeficiency Syndrome [AIDS] or systemic lupus erythematosus [SLE]) or drug-related thrombocytopenia.
2. Administration of intravenous immunoglobulin (IGIV), anti-D or thrombopoetin receptor agonists or other platelet enhancing drugs (incl. immunosuppressive or other immunomodulatory drugs) within 3 weeks before enrollment, except for:
a) long-term corticosteroid therapy when the dose has been stable during the preceding 3 weeks and no dosage change is planned until study Day 22.
b) long-term azathioprine, cyclophosphamide or attenuated androgen therapy when the dose has been stable during the preceding 3 months and no dosage change is planned until study Day 22.
3. Unresponsive to previous treatment with IGIV or anti-D immunoglobulin.
4. Experimental treatment (e.g. Rituximab) within 3 months before enrollment.
5. Splenectomy in the previous 4 weeks or planned splenectomy throughout the study period.
6. Subject with Evans syndrome (autoimmune thrombocytopenia and autoimmune hemolysis).
7. Known or suspected human immunodeficiency virus (HIV) or hepatitis C virus (HCV) infection
8. Live viral vaccination within the last two months before study entry.
9. Emergency operation.
10. Severe liver or kidney disease (alanine aminotransferase [ALAT] 3x > upper limit of normal, creatinine >120 µmol/L).
11. Congestive heart failure New York Heart Association (NYHA) class III or IV.
12. Non-controlled arterial hypertension (systolic blood pressure >160 mmHg or diastolic blood pressure >90 mmHg).
13. History of hypersensitivity to blood or plasma derived products, or any component of the investigational product.
14. Known immunoglobulin A (IgA) deficiency and antibodies against IgA.
15. History of, or suspected alcohol or drug abuse.
16. Pregnant or nursing women.
17. Unable or unwilling to comply with the study protocol.
18. Participating in another interventional clinical study and receiving investigational medicinal product within three months before study entry.
19. Patients with body mass index ≥ 30kg /m2
20. Patients with risk factors(i) for thromboembolic events in whom the risks outweigh the potential benefit of NewGam treatment
(i) Such as obesity,advanced age , hypertension, diabetes, a history of atheroschlerosis/vascular disease or thrombotic events , hyperlipidaemia, multiple cardiovascular risk factors, acquired or inherited thrombophilic disorders, prolonged periods of immobilization, severe hypvoleamia, central venous catheterization, active malignancy and/or known or suspected hyperviscosity.
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
The primary objective of the study is to assess the efficacy of NewGam in correcting the platelet count.
Day 8
Secondary Outcome
Outcome
TimePoints
The secondary objective of the study is to evaluate the safety and the efficacy of NewGam.
Efficacy outcome- Day 22
Safety Outcome- Day 63
Target Sample Size
Total Sample Size="95" Sample Size from India="20" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
This
study is a Prospective, open-label, non-controlled, multicenter, phase III
clinical study to evaluate the efficacy and safety of immunoglobulin
intravenous (human) 10% (NewGam) in approximately 95 patients with Primary
Immune Thrombocytopenia that will be conducted approximately 35 centers in India & in Europe.
The
Primary outcome measures will be to assess the efficacy of NewGam in correcting
the platelet count. The secondary outcome will be to evaluate the safety of
NewGam.