| CTRI Number |
CTRI/2020/06/025707 [Registered on: 08/06/2020] Trial Registered Prospectively |
| Last Modified On: |
20/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical study to compare effects and safety of Recombinant Human Thrombopoietin (rhTPO) Injection with Romiplostim injection in Indian Patients with Immune Thrombocytopenia |
|
Scientific Title of Study
|
A Phase III, Randomized, Open-Label, Multicentre Clinical Trial to evaluate the efficacy and safety of Recombinant Human Thrombopoietin (rhTPO) Injection compared with Romiplostim injection in Indian Patients with Immune Thrombocytopenia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BIO/CT/19/0000101 |
DCGI |
| CT-TPIAO-001-ITP-2019 Version 1.0 dated 05 Dec 2019 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abhay Bhave |
| Designation |
Principal Investigator |
| Affiliation |
Leelavati Hospital and Research Centre |
| Address |
Leelavati Hospital and Research Centre, A791,Bandra Reclamation, Bandra west
Mumbai
MAHARASHTRA
400050
India |
| Phone |
9820238559 |
| Fax |
|
| Email |
bhaveabhay@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Viraj Suvarna |
| Designation |
President Medical |
| Affiliation |
Eris Lifesciences Ltd |
| Address |
8th floor, Commerce House-4
Prahlad Nagar, Ahmedabad
Ahmadabad
GUJARAT
380015
India |
| Phone |
07930451111 |
| Fax |
07930179404 |
| Email |
viraj.suvarna@erislifesciences.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neeta Nargundkar |
| Designation |
Managing Director |
| Affiliation |
Biosphere Clinical Research Pvt.Ltd |
| Address |
Office No. 02, 03 & 04, 2nd Floor
Highland Corporate Center, Kapurbawdi Junction,
Thane
MAHARASHTRA
400607
India |
| Phone |
02241006794 |
| Fax |
|
| Email |
drneeta@biospherecro.com |
|
|
Source of Monetary or Material Support
|
| Eris Lifesciences Ltd
8th floor, Commerce House-4 Prahlad Nagar, Ahmedabad – 380015 Gujarat, India |
|
|
Primary Sponsor
|
| Name |
Eris Lifesciences Ltd |
| Address |
8th floor, Commerce House-4 Prahlad Nagar, Ahmedabad – 380015 Gujarat, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 19 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Tulika Seth |
All India Institute of Medical Sciences |
Department of Hematology,All India Institute of Medical Sciences,Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi-110029
New Delhi
DELHI |
9811262092
drtulikaseth@gmail.com |
| Dr Ashutosh Panigrahi |
All India Institute of Medical Sciences, Bhubaneswar |
Department of Medical
Oncology/Hematology
,Sijua, Patrapada,
Odisha-751019
Khordha
ORISSA |
91-8249223471
dr.ashupanigrahi@gmail.com |
| Dr Jigar Patel |
Aman Hospital and Research Centre, |
15, Shashwat, Opp.E.S.IHospital,Gotri Hospital, Vadodara-390021,Gujarat - 390021 India
Vadodara
GUJARAT |
91-9879794049
jigarpatel5785@gmail.com |
| DrNeeraj Sidharthan |
Amrita Institute of Medical Sciences |
Amrita Institute of
Medical Sciences and
Research Centre
(AIMS) Department of
Medical Oncology and
Hematology Peeliyadu
Road, Ponekkara,
Edappally Kochi, Kerala
– 682 041
Ernakulam
KERALA |
91-9946047464
neerajsidharthan@aims.amrita.edu |
| Dr Satish Kumar A |
Columbia Asia Referral Hospital Yeshwanthpur |
Columbia Asia Referral
Hospital-Yeshwanthpur, Department of Hematology,
No. 26/4, Brigade Gateway, Malleshwaram, West, Beside Metro, Bengaluru-560055, India
Bangalore
KARNATAKA |
91-8030925454
satishkumar.a@columbiaasia.com |
| Dr Rohan Bhise |
KLE Dr Prabhakar Kore Hospital and MRC |
OPD No. 25, First floor, Nehru Nagar, Belagavi-590010
Belgaum
KARNATAKA |
9448866712
rohanbhise30@gmail.com |
| Dr Abhay Bhave |
Lilavati Hospital and Research Centre |
Department of Research, A-791, Bandra Reclamation Road, Bandra West, Mumbai-400050
Mumbai
MAHARASHTRA |
9820238559
bhaveabhay@hotmail.com |
| Dr Manoj Toshniwal |
Mahatma Gandhi Missions Medical College & Hospital |
Department of Clinical Pharmacology & Therapeutics,MGM Medical College and Hospital
N-6 Cidco, Aurangabad-431003
Aurangabad
MAHARASHTRA |
9225300842
dr.manojtwal@gmail.com |
| DrSharat Damodar |
Mazumdar Shaw Medical center, A unit of Narayana Hrudayalaya Ltd |
Department of Haematology,
NH Health City
No,258/A, Bommasandar Industrial Area, Anekal taluk, Bengaluru- (Bangalore) 560099
Bangalore
KARNATAKA |
9880437134
drsharat.damodar@gmail.com |
| Dr Kasi Viswanathan Thiagarajan |
Meenakshi Mission Hospital and Research Centre |
Department of
Haematology and Bone
Marrow Transplantation
,Meenakshi Mission
Hospital and Research
Centre,Lake Area,
Melur Road,
Madurai-625107
Madurai
TAMIL NADU |
91-9385596139
kasi.mmhrc@gmail.com |
| Dr Siddhesh Kalantri |
NAMCO Charitable Trust’s SGS Cancer Hospital |
Department of Haematology,
Plot No. 30/1/1B/1 &
30/2/2C/2, Opp. R T O
Office, Sardar Vallabhai
Patel Marg,Peth Road,
Panchvati,
Nashik-422004
Nashik
MAHARASHTRA |
91-8437649501
sidkalantri@gmail.com |
| Dr Tuphan Kanti Dolai |
Nil Ratan Medical College & Hospital |
Room no. 7, Department of hematology, centenary building, 138 AJC Bose Road, Kolkata- 700014
Kolkata
WEST BENGAL |
9874890275
tkdolai@hotmail.com |
| Dr Narendra Agrawal |
Rajiv Gandhi Cancer Institute & Research Centre |
Department of
Haematology, Room
no. 3257, Second
Floor,Sector-5, Rohini,
Delhi-110085
North West
DELHI |
91-9868764808
narendra_ag1@rediffmail.com |
| DrShashikant Apte |
Sahyadri Superspeciality Hospital |
Department of Hematology and BMT,Plot No.30 C, Erandawane, Karve road, Pune, Maharashtra.
Pune
MAHARASHTRA |
91-9822404983
shashikant.apte@gmail.com |
| Dr Vikash Goyal |
Sanjeevani CBCC USA Cancer Hospital |
Department of Hematology,Sanjeevani CBCC USA Cancer Hospital,In front of Jain mandir,
dawada colony,
pachpedinaka, Raipur
-492001
Raipur
CHHATTISGARH |
91-9300872740
drvikas20@gmail.com |
| Dr Chandrakala Shanmukhaiah |
Seth G.S. Medical College and KEM Hospital |
Ward No 42, 10th Floor, Department of Haematology, Acharya Donde Marg, Parel, Mumbai 400012
Mumbai
MAHARASHTRA |
91-22-24107986
drchandra_s@rediffmail.com |
| DrMahesh Rajashekaraiah |
Sparsh Super Speciality Hospital |
Department of Hamatology,4/1, Tumkur Road, Yeshwantpur, Banglore-560022
Bangalore
KARNATAKA |
91-7406016591
maheshhemat@gmail.com |
| Dr Ross Cecil |
St. Johns Medical College and Ilospital |
Dept, of Medicine and Hematology
St. Johns Medical College and Hospital
Sarjapur Road, Bangalore- 560034
Bangalore
KARNATAKA |
9448493705
cecil.ross@stjohns.in |
| DrJeevan Kumar |
Tata Medical Centre |
Department of Clinical Hematology and BMT,
14-Mar (E-W), Rajarhat, Kolkata-700160, India.
Kolkata
WEST BENGAL |
91-9007016755
jeevan.kumar@tmckolkata.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 19 |
| Name of Committee |
Approval Status |
| Ethics Committee All India Institute of Medical Sciences |
Submittted/Under Review |
| Ethics Committee N.R.S Medical College |
Submittted/Under Review |
| Ethics committee Tata Medical Centre |
Submittted/Under Review |
| Ethics Committee, Sanjeevani Cancer Hospital |
Approved |
| Institute of Institutional Ethics Amrita Institute of Medical Sciences |
Submittted/Under Review |
| Institution review Board,Rajiv Gandhi Cancer Institute and Research Centre |
Submittted/Under Review |
| Institutional Ethics Committee All India Institute of Medical Sciences |
Submittted/Under Review |
| Institutional Ethics Committee Aman Hospital and Research Centre |
Approved |
| Institutional Ethics Committee Columbia Asia Columbia Asia Referral Hospital-Yeshwanthpur |
Approved |
| Institutional Ethics Committee Meenakshi Mission Hospital and Research Centre |
Submittted/Under Review |
| Institutional Ethics Committee Seth GS Medical College and KEM Hospital, Mumbai. |
Submittted/Under Review |
| Institutional Ethics Committee Sparsh Hospital |
Approved |
| Institutional Ethics Committee St. Johns Medical College Hospital |
Submittted/Under Review |
| Institutional Ethics Committee, KLE University |
Submittted/Under Review |
| Institutional Ethics Committee- Lilavati Hospital and Research Center |
Submittted/Under Review |
| MGM Ethics Committee for Research on Human Subjects (MGM-ECRHS) |
Approved |
| Namco Hospital Ethics Committee |
Submittted/Under Review |
| Narayana Health Medical Ethics Committee |
Approved |
| Sahyadri Hospitals Ltd. Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D693||Immune thrombocytopenic purpura, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Recombinant Human Thrombopoietin (rhTPO) injection |
Recombinant Human Thrombopoietin (rhTPO) injection, will be administered subcutaneously at 1.0 μg/kg (300U/kg) once daily for 14 days. |
| Comparator Agent |
Romiplostim injection |
Romiplostim injection at dose of 1-3 μg/kg (250 mcg) subcutaneously once a week calculated as per the body weight and later the weekly dose will be increased based on the platelet response |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and Female, aged 18 to 65 years old
2. Meeting the following criteria of ITP:
a. Thrombocytopenia by repeated lab tests.
b. Bone marrow examination shows megakaryocyte count increasing or at normal level with dysmaturity.
3. Patients with Platelet count ≤ 20×109/L at any time during the screening period, who are non-responsive to standard or high-dose glucocorticoids.
4. Patients without splenectomy.
5. Patients willing to give written validinformed and signed consent. |
|
| ExclusionCriteria |
| Details |
1. Pregnant or lactating women or patients not willing to adopt contraceptive measures during the trial.
2. Patient with Thrombosis history.
3. Patients with a diagnosis of secondary thrombocytopenia.
4. Patients with hepatorenal dysfunction (serum transaminase and bilirubin are over 1.5 folds of normal upper limit, and creatinine ≥1.5mg/dl).
5. Patients with severe cardiorespiratory dysfunction.
6. Patients who have active malignancy.
7. Patient with hypersensitivity to study drug or any of its excipients.
8. Patients on other thrombopoietin receptor agonists (Eltrombopag) as they compete with TPIAO for TPO receptor binding.
9. Patients with concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent.
10.Patients with suspected inability to comply with the study procedure. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Compare the complete response rate; Platelet count ≥ 100 X 109 /L and
absence of bleeding between two groups.
2. Compare the response rate ;Platelet count between ≥ 30 X 109 /L and 100 X 109 /L and at least double of the baseline count and absence of bleeding between two groups
3.Compare the total response rate between two groups. |
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Compare the maximum value and increment in platelet count between two groups
2.Compare the frequencies and total volume of platelet transfusion between two groups
3.Observe the time of platelet count to complete response (reaching ≥100×109/L) and maintenance duration. |
14 days |
| 4.Occurrence of non neutralizing or neutralizing TPO antibodies. |
28 days |
| 5.The assessment of safety will be based on the frequency of Adverse Event. Change in vital signs and laboratory parameters |
28 days |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
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 3 |
|
Date of First Enrollment (India)
|
30/06/2020 |
| 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) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is A Phase III, Randomized, Open-Label, Multicentre Clinical Trial to evaluate the efficacy and safety of Recombinant Human Thrombopoietin (rhTPO) Injection compared with Romiplostim injection in Indian Patients with Immune Thrombocytopenia.
The Primary endpoints are: 1.Compare the complete response rate; Platelet count ≥ 100 X 109 /L and absence of bleeding between two groups. 2.Compare the response rate ; Platelet count between ≥ 30 X 109 /L and 100 X 109 /L and at least double of the baseline count and absence of bleeding between two groups 3.Compare the total response rate between two groups.
The Secondary endpoints are: 1.Compare the maximum value and increment in platelet count between two groups 2.Compare the frequencies and total volume of platelet transfusion between two groups 3.Observe the time of platelet count to complete response (reaching ≥100×109/L) and maintenance duration. 4.Occurrence of non neutralizing or neutralizing TPO antibodies.
Safety Endpoint 1.The assessment of safety will be based on the frequency of Adverse Event. Change in vital signs and laboratory parameters
|