| CTRI Number |
CTRI/2017/11/010620 [Registered on: 23/11/2017] Trial Registered Prospectively |
| Last Modified On: |
29/04/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to assess Inj. Romiplostim in patients with Low levels of the blood cells that prevent bleeding |
|
Scientific Title of Study
|
A Prospective, Assessor-blind, Randomized, Parallel group Clinical Trial to Assess Single Dose Pharmacokinetics and Pharmacodynamics of Inj. Romiplostim from Intas Pharmaceuticals Ltd. and Inj. Romiplostim of Amgen Inc. in Patients with Chronic Refractory Immune (Idiopathic) Thrombocytopenic Purpura |
| Trial Acronym |
NA |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| 1005-16, Version 4.0 Dated 15 May 2018 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Mr Sumanta Nandi |
| Designation |
Project Manager |
| Affiliation |
Lambda Therapeutic Research Ltd |
| Address |
Lambda House, Plot no. 38, Survey No. 388
Near Silver Oak Club,
S. G. Highway, Gota
Ahmadabad
GUJARAT
382481
India |
| Phone |
07940202057 |
| Fax |
07940202021 |
| Email |
sumantanandi@lambda-cro.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Kenil Ghorecha |
| Designation |
Assistant Manager |
| Affiliation |
Lambda Therapeutic Research Ltd |
| Address |
Lambda House, Plot no. 38, Survey No. 388
Near Silver Oak Club,
S. G. Highway, Gota
Ahmadabad
GUJARAT
382481
India |
| Phone |
07940202597 |
| Fax |
07940202021 |
| Email |
kenildghorecha@lambda-cro.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Mr Sumanta Nandi |
| Designation |
Project Manager |
| Affiliation |
Lambda Therapeutic Research Ltd |
| Address |
Lambda House, Plot no. 38, Survey No. 388
Near Silver Oak Club,
S. G. Highway, Gota
Ahmadabad
GUJARAT
382481
India |
| Phone |
07940202057 |
| Fax |
07940202021 |
| Email |
sumantanandi@lambda-cro.com |
|
|
Source of Monetary or Material Support
|
| Intas Pharmaceuticals Limited, Plot No. 423/P/A, Sarkhej-Bavla Highway,
Moraiya, Tal: Sanand, Ahmedabad-382213
Tel. No.: 02717660100,Fax No.: 02717660105 |
|
|
Primary Sponsor
|
| Name |
Intas Pharmaceuticals Limited |
| Address |
Plot No. 423/P/A, Sarkhej-Bavla Highway,
Moraiya, Tal: Sanand, Ahmedabad-382213
Tel. No.: 02717660100,Fax No.: 02717660105 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Eva Bhagat |
HCG Hospitals |
HCG Hospital,Department of clinical research,Room no NA Methakhali, Ellisbridge
Ahmadabad
GUJARAT |
09825016858
evabhagat@Yahoo.com |
| Dr Niraj Bhatt |
Kailash Cancer Hospital & Research Center |
Department of clinical research, Room no NA,Seva Ashram, Goraj, Waghodia-391760
Vadodara
GUJARAT |
09925581480
medonc12@gmail.com |
| Dr Tuphan Kanti Dolai |
N.R.S. Medical College & Hospital |
Haematology Department,4th Floor, 138, A.J.C.Bose Road-700014.
Kolkata
WEST BENGAL |
09874890275
tkdolai@hotmail.com |
| Dr Mitesh Halvawala |
Nirmal Hospital Pvt Ltd., |
Department of clinical research, Room no NA,Ring Road-395002
Surat
GUJARAT |
09825109995
drmitesh@ymail.com |
| Dr Avinash Kumar Singh |
Paras HMRI Hospital  |
Department of clinical research, Room no NA,NH 30, Raja Bazar,Bailey Rd, MLA Colony, Raja Bazar-800001
Patna
BIHAR |
07543015099
anvinash.pmch@gmail.com |
| Dr Hemant Malhotra |
R K Birla Cancer Centre |
Department of clinical research, Room no NA, SMS Medical College & Attached Hospital, JLN Marg-302004
Jaipur
RAJASTHAN |
09829062040
drmalhotrahemant@gmail.com |
| Dr Ankit Patel |
Unique Hospital-Multispeciaity &Research Institute |
Department of clinical research, Room no NA,Opp. Kiran Motor, Near Canal, Civil Hospital Char Rasta - Sosyo Circle Lane, Off Ring Road-395002,
Surat
GUJARAT |
09825404202
ankit_ahm1985@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| Ethics Committee SMS Medical College and Attached Hospitals ,Dr Hemant Malhotra |
Submittted/Under Review |
| Ethics Committee, N.R.S. Medical College ,Dr. Tuphan Kanti Dolai |
Approved |
| Ethics Committee, Unique Hospital-Multispeciality & Research Institute,Dr. Ankit Patel |
Approved |
| Ethics Committee,Paras HMRI Hospital,Dr. Avinash Kumar Singh |
Approved |
| HCG Multi Specialty Ethics Committee, HCG Hospital,Dr Eva Bhagat |
Approved |
| Instituitional Ethics Committe, Kailash Cancer Hospital & Research Center, Dr. Niraj Bhatt |
Approved |
| Nirmal hospital Ethics committee situated at Nirmal Hospital Pvt. Ltd.,Dr Mitesh Halvawala |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
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 |
Romiplostim Powder and Solvent for Solution for Injection of Amgen Inc |
Dose: 3.00 mcg/kg; Frequency: Single Dose; Mode of Administration: Subcutaneous; Duration of treatment: Single dose |
| Intervention |
Romiplostim Powder and Solvent for Solution for Injection of Intas Pharmaceuticals Limited |
Dose: 3.00 mcg/kg; Frequency: Single Dose; Mode of Administration: Subcutaneous; Duration of treatment: Single dose |
|
|
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. Patients in good health as determined by past medical history, physical examination, vital signs (Heart rate, blood pressure, respiratory rate and oral body temperature), ECG and laboratory tests at screening
3. Subject must weigh at least 50 kg to participate in the study and must have body mass index (BMI) within the range of 18-30 kg/m2
4. Diagnosis of ITP according to American Society of Haematology (ASH) guidelines at least 3months before enrolment
5. Have completed at least 1 prior treatment for ITP
6. Subject (or legally acceptable representative) is willing and able to provide written informed consent
7. Patient must be able to communicate well with the investigator, adhere to the study visit schedule, understand and comply with all protocol requirements. |
|
| ExclusionCriteria |
| Details |
1. Previously patients have taken romiplostim during last one year
2. History of hematological malignancy, myeloproliferative disorder, myelodysplastic syndrome (MDS), or bone marrow stem cell disorder.
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. Pregnant or breast feeding
9. Use of other investigational drug at the time of enrollment or within 30 days or 5 half-lives of enrollment, whichever is longer
10. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
11. Nursing (lactating) women
12. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means unless they are using acceptable methods of contraception
13. Fertile males, defined as all males physiologically capable of conceiving offspring unless the subjects agrees to comply with effective contraceptive methods for the entire duration and refrain from fathering a child for at least 3 months following last study drug administration
14. Smokers (use of tobacco products in the previous 3 months)
15. Use of any prescription drugs, herbal supplements which are known to interfere with pharmacokinetics or pharmacodynamics of romiplostim
16. Donation or loss of 400 ml or more of blood or equivalent plasma within 8 weeks prior to initial dosing or longer if required by local regulation
17. Significant illness within 2 weeks prior to initial dosing
18. History of immunodeficiency diseases including a positive HIV test result. A positive HBsAg or Hepatitis C test results
19. Any other condition that in the opinion of investigator could hamper participation in the study
20. History of drug or alcohol abuse within 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during screening and/or baseline |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of pharmacokinetic parameters of Inj. Romiplostim from Intas Pharmaceuticals Ltd. and Inj. Romiplostim of Amgen Inc. in chronic refractory immune (idiopathic) thrombocytopenic purpura patients |
Visit 2 to visit 9 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Assessment safety and tolerability of Inj. Romiplostim from Intas Pharmaceuticals Ltd. and Inj. Romiplostim of Amgen Inc
2. Assessment of pharmacodynamics of Inj. Romiplostim from Intas Pharmaceuticals Ltd. and Inj. Romiplostim of Amgen Inc. |
Visit 1 to Visit 10 |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
21/12/2017 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Immune thrombocytopenia (ITP) is an autoimmune syndrome involving antibody- and cell-mediated destruction of platelets and suppression of platelet production by the bone marrow (BM) megakaryocytes that may predispose to bleeding. 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. Romiplostim has been approved globally including US, EU, Canada, Australia etc since 2008. Romiplostim has not yet approved in India. Intas Pharmaceuticals has developed biosimilar Romiplostim, which is similar to Innovator’s product in terms for chemical and preclinical characteristics. Efficacy and safety of Romiplostim manufactured by Intas Pharmaceuticals Ltd has already proven in Indian population in a phase III clinical study. Aim of the current study is to evaluate pharmacokinetics of Romiplostim in Indian population. It is a Prospective, Assessor-blind, Randomized, Parallel group clinical study. The present study will be carried out to generate pharmacokinetics, pharmacodynamics and safety data from 24adult patients (12 patients per arm) of both the genders aged 18 to 65 years (both inclusive) years with chronic refractory ITP at different clinical sites across India. Adult patients of both the genders with chronic refractory ITP will be screened for Inclusion/Exclusion criteria. The study will consist of a 1 week of screening period, dosing on day 0 and 4 weeks of follow-up period. Patients will be screened for eligibility over 1 week period. Physical examination, vital signs, and laboratory testing will be performed at the screening visit. All patients will be given 3 mcg/kg dose of Romiplostim on day 0. Total 25 blood samples (3 mL each) will be collected for pharmacokinetic assessment. Total 7 blood samples will be collected for pharmacodynamics assessment. Pharmacodynamic assessment will be performed at central lab using standard validated method. Safety of the patients will be ensured during entire duration of the study. |