| CTRI Number |
CTRI/2015/09/006197 [Registered on: 17/09/2015] Trial Registered Prospectively |
| Last Modified On: |
21/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study to Evaluate the Efficacy and Safety of Inj. Romiplostim of Intas Pharmaceuticals Ltd. in Adult Indian Patients with Idiopathic Thrombocytopenic Purpura. |
|
Scientific Title of Study
|
A Prospective, Open-label, Multi-centric Study to Evaluate the Efficacy and Safety of Inj. Romiplostim of Intas Pharmaceuticals Ltd. in Adult Indian Patients with Chronic Refractory Idiopathic Thrombocytopenic Purpura. |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 063-15, Version: 2.0, Date: 22/05/2015 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ravi Panchal |
| Designation |
Project Manager |
| Affiliation |
Lambda Therapeutic Research Ltd |
| Address |
Plot No. 38, Near Silver Oak Club
S. G. Highway, Gota
Ahmadabad
GUJARAT
380061
India |
| Phone |
07940202564 |
| Fax |
07940202021 |
| Email |
raviapanchal@lambda-cro.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Nil Desai |
| Designation |
Asst. Manager |
| Affiliation |
Lambda Therapeutic Research Ltd |
| Address |
Plot No. 38, Near Silver Oak Club
S. G. Highway, Gota
Ahmadabad
GUJARAT
380061
India |
| Phone |
07940202546 |
| Fax |
07940202021 |
| Email |
nildesai@lambda-cro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ravi Panchal |
| Designation |
Project Manager |
| Affiliation |
Lambda Therapeutic Research Ltd |
| Address |
Plot No. 38, Near Silver Oak Club
S. G. Highway, Gota
Ahmadabad
GUJARAT
380061
India |
| Phone |
07940202564 |
| Fax |
07940202021 |
| Email |
raviapanchal@lambda-cro.com |
|
|
Source of Monetary or Material Support
|
| Intas Pharmaceuticals Ltd, Plot No. 423/P/A, Sarkhej-Bavla Highway, Moraiya, Tal: Sanand, Ahmedabad-382 213 |
|
|
Primary Sponsor
|
| Name |
Intas Pharmaceuticals Ltd |
| Address |
Plot No. 423/P/A, Sarkhej-Bavla Highway, Moraiya, Tal: Sanand, Ahmedabad-382 213 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jose M Easow |
Apollo Speciality Hospital |
320, Padma Complex, Teynampet, Chennai- 600035
Chennai
TAMIL NADU |
09841700827
joseeasow@yahoo.com |
| Dr Rahul Bhargava |
Artemis Hospitals |
Department of Haematology, Room no. 10, Sector-51-122001
Gurgaon
HARYANA |
9958174994
bhargava777@gmail.com |
| Dr Vikram Mathwes |
Christian Medical College |
Department of Haematology, Room no. 5- 632004
Vellore
TAMIL NADU |
04162282352
vikram@cmcvellore.ac.in |
| Prof Maitreyee Bhattacharyya |
Institute of Hematology and Transfusion Medicine |
3rd Floor, Department of Clinical Hematology, Room no. 14, MCH Building, Medical College, 88 College Street-700073
Kolkata
WEST BENGAL |
9836018052
mbhattyacharyya@yahoo.co.in |
| Dr Tuphan Kanti Dolai |
N.R.S. Medical College & Hospital |
Haematology Department, 138, A.J.C.Bose Road – 700014.
Kolkata
WEST BENGAL |
9874890275
tkdolai@hotmail.com |
| Dr Narendra Agrawal |
Rajiv Gandhi Cancer Institute & Research Centre |
Department of Haematology, Room no. 12, Sector-5, Rohini, Delhi-110085
North West
DELHI |
9868764808
narendra_ag1@rediffmail.com |
| DrSameer Malinkeri |
Sahyadri Speciality Hospital |
Department of Hematology, Room no. 17, 30 C Erandwane, Karve Road-411004
Pune
MAHARASHTRA |
9766249644
docmelinkeri@yahoo.com |
| Dr Sanjukta Rao |
St. Johns Medical College& Hospital |
Department of Medicine, Room no. 22, Sarjapur Road - 560034,
Bangalore
KARNATAKA |
9886508910
sanjuktaarao@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 11 |
| Name of Committee |
Approval Status |
| Artemis Health Sciences Institutional Ethics Committee, Dr Rahul Bhargava |
Submittted/Under Review |
| Ethics Committee, N.R.S. Medical College & Hospital, Dr Tuphan Kanti Dolai |
Submittted/Under Review |
| Ethics Committee, SMS Medical College Hospital, Dr Hemant Malhotra |
Submittted/Under Review |
| Institutional Ethics Committee, Apollo Hospitals, Dr. Jose |
Approved |
| Institutional Ethics Committee, Institute of Hematology and Transfusion Medicine, Prof Maitreyee Bhattacharyya |
Submittted/Under Review |
| Institutional Ethics Committee, Rajiv Gandhi Cancer Institute & Research Centre, Dr Narendra Agrawal |
Submittted/Under Review |
| Institutional Ethics Committee, S.C.B. Medical College, Dr Rabindra Kumar Jena |
Submittted/Under Review |
| Institutional Ethics Committee, St.Johns National Academy of Health Sciences, Dr Sanjukta Rao |
Approved |
| Institutional Review Board, Ethics Committee - Silver, Christian Medical College, Dr Vikram Mathwes |
Approved |
| Narayana Health Medical Ethics Committee, Dr Sharat Damodar |
Submittted/Under Review |
| Sahyadri Hospital Ltd. Ethics Committee, DrSameer Malinkeri |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D693||Immune thrombocytopenic purpura, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
Romiplostim Powder and Solvent for Solution for Injection |
Dose:250 & 500 mcg Lyophilized Powder vial, Frequency: Once in a week,
Mode of Administration: Subcutaneous, Duration of treatment: 7 weeks
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and Female patients aged between 18 to 65 years (both inclusive)
2. Diagnosis of ITP according to American Society of Haematology (ASH) guidelines at least 12months before enrolment4
3. Have completed at least 1 prior treatment for ITP
4. Value of platelet count must be: (i) less than 30000/μL for those patients not receiving any ITP therapy (ii) less than 50000/μL for those patients receiving a constant dose schedule of corticosteroids
5. Written informed and signed consent
6. Patient must be able to adhere to the study visit schedule, understand, and comply with all protocol requirements.
|
|
| ExclusionCriteria |
| Details |
1. History of hematological malignancy, myeloproliferative disorder, myelodysplastic syndrome (MDS), or bone marrow stem cell disorder
2. Positive test for human immunodeficiency virus (HIV) infection or hepatitis C virus
3. Currently receiving any treatment for ITP except oral corticosteroids, azathioprine and/or danazol administered at a constant dose and schedule from at least 4 weeks prior to the screening visit
4. Received intravenous immunoglobulin, anti-D immunoglobulin, or any drug administered to increase platelet counts (e.g., immunosuppressants etc) within 1 week before the screening visit
5. Received hematopoietic growth factors (e.g., granulocyte colony stimulating factor, macrophage colony stimulating factor, erythropoietin, interleukin 11) for any reason within 4 weeks before the screening visit
6. Received any monoclonal antibody (e.g., rituximab) within 8 weeks before the screening visit or anticipated use during the time of the proposed study
7. Less than 2 months since major surgery
8. Any other condition that in the opinion of investigator could hamper participation in the study
9. Previous participation in any clinical trial within 1 month before the entry of the study
10. Pregnant or breast feeding
11. Subjects of reproductive potential who are not using adequate contraceptive precautions, in the judgment of the investigator
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of subjects achieving platelet response (Platelet response is defined as a platelet count at a scheduled weekly visit of 50000/μL or more and double the platelet count from baseline in the absence of rescue medication within the 8 weeks.) |
Baseline to week 8 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•Dose required to achieve targeted platelet count (50000/μL)
•Proportion of patients with at least one dose increment
•Proportion of patients with at least one dose reduction
•Patients having Platelet count ≥400000/ μL |
Baseline to week 8 |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
25/09/2015 |
| Date of Study Completion (India) |
26/05/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Romiplostim is a novel thrombopoiesis-stimulating
protein that has been developed as a treatment for adults with thrombocytopenia
associated with ITP. Romiplostim provides an effective approach for the
treatment of ITP. As demonstrated in two multicentre, placebo-controlled, Phase
III studies, Romiplostim robustly maintains platelet counts at clinically
meaningful levels in both splenectomised and non-splenectomised patients, as
compared to patients receiving only standard of care ITP medications, with
response rates generally better than those medications. Romiplostim
has been approved globally including US, EU, Canada, Australia etc since 2008.
Romiplostim has not yet approved in India. Also, India was not the part of
Innovator’s Global clinical trial programme. Hence, safety and efficacy of
Romiplostim is unproven in Indian Population. Intas Pharmaceuticals has
developed biosimilar Romiplostim, which is similar to Innovator’s product in
terms for chemical and preclinical characteristics. Aim of the current study is
to evaluate the efficacy and safety of Intas Romiplostim in Indian population. |