CTRI/2025/08/092989 [Registered on: 13/08/2025] Trial Registered Prospectively
Last Modified On:
11/06/2026
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Biological
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
A comparative study of Romiplostim Biosimilar with Nplate in Immune Thrombocytopenia patients.
Scientific Title of Study
A prospective randomized double-blind multi centre parallel arm comparative clinical study to
determine the efficacy and safety of Romiplostim Biosimilar manufactured by Levim Lifetech Private
Limited with Nplate manufactured by Amgen in patients with immune thrombocytopenia ITP
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
LBL-CT-20-003 Protocol version 3.2 dated 24 Oct 2024
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Jayashri Krishnan
Designation
Vice President Operations
Affiliation
JSS Medical Research Asia Pacific Private Limited
Address
Tower 2 1st Floor South Wing L&T Business Park Plot no 12 slash 4 Sector 27 D Delhi Mathura Road Near Sarai Khawja Metro Station
Faridabad HARYANA 121003 India
Phone
09771407484
Fax
0129-6613520
Email
jayashri.krishnan@jssresearch.com
Details of Contact Person Scientific Query
Name
Dr Sonika Newar
Designation
GM Medical Monitoring and Safety
Affiliation
JSS Medical Research Asia Pacific Private Limited
Address
Tower 2 1st Floor South Wing L&T Business Park Plot no 12 slash 4 Sector 27 D Delhi Mathura Road Near Sarai Khawja Metro Station
Faridabad HARYANA 121003 India
Phone
09771407484
Fax
01296613520
Email
sonika.newar@jssresearch.com
Details of Contact Person Public Query
Name
Dr Jayashri Krishnan
Designation
Vice President Operations
Affiliation
JSS Medical Research Asia Pacific Private Limited
Address
Tower 2 1st Floor South Wing L&T Business Park Plot no 12 slash 4 Sector 27 D Delhi Mathura Road Near Sarai Khawja Metro Station
Faridabad HARYANA 121003 India
Phone
09771407484
Fax
01296613520
Email
jayashri.krishnan@jssresearch.com
Source of Monetary or Material Support
Levim Lifetech Private Limited
TICEL Biopark Limited Phase II 5th Floor
CSIR Road, Taramani
Chennai 600 113 India
Primary Sponsor
Name
Levim Lifetech Private Limited
Address
TICEL Biopark Limited Phase II 5th Floor CSIR Road, Taramani Chennai 600 113 India
Level 6, Medical College Building, Department of Medical Oncology and Haematology, Veerbhadra road, Rishikesh, Uttarakhand - 249203 Dehradun UTTARANCHAL
9433982756
nath.uttam@gmail.com
Dr Aman Khanna
Aman Hospital and Research centre
Consultation room, Ground floor, Depart of Clinical Research, 15 Shashwat, Gotri Road, opposite ESI Hospital, Vadodara, Gujarat 390021 Vadodara GUJARAT
9904402122
amankhanna170974@gmail.com
Dr Neeraj Sidharthan
Amrita Institute of Medical Science
Room No 5, 4th floor, G block, Department of Clinical Haematology, Amrita Institute of Medical Science, Ponekkara P.O, Kochi, Kerala, India - 682041 Ernakulam KERALA
9946047464
neerajsidharthan@sims.amrita.edu
Dr Rahaul Naithani
Artemis Hospital
Room no. 3001, Tower 3, Ground floor, Department of Haemato-Oncology, Sector 51, Gurugram, Bindapur, Haryana 122001 Gurgaon HARYANA
8800175901
Rahul.Naithani@artemishospitals.com
Dr Ria Ballikar
Arunodaya Heart and Hematology Centre
OPD Room No 01, Ground Floor, Tamaskar Clinic, Department of Haematology, Plot 17, beside Milestone Building, near Lokmat Square, New Ramdaspeth, Nagpur, Maharashtra 440010, India Nagpur MAHARASHTRA
8334988584
riabalikar86@gmail.com
Dr Raut lalit
Aureus Institute of Medical Sciences
OPD Romm 3, 1st Floor, Deapartment of Haematology,Aureus Institute of Medical Sciences Plot No. 16, Wanjari Nagar, Medical college road,Nagpur-440003, Maharashtra, India Nagpur MAHARASHTRA
9326992625
lalitraut76@yahoo.com
Dr Varun Ashok Bafna
Dr Bafnas Star Superspeciality Clinic and Hospital
OPD Room No 1, Ground floor, Department of Haematology, Rukmini Nagar, E Ward, Near LIC Ground, Kolhapur - 416005 Kolhapur MAHARASHTRA
9066565353
starresearch22@gmail.com
Dr Sunit Lokwani
HCG Cancer Centre
OPD Room No 5, Gorund floor, Department of Medical Oncology & Haematology, 142, AB Rd, near LIG Square, Phadnis Colony, Indore – 452008, Madhya Pradesh, India Indore MADHYA PRADESH
9611117398
drsunit85@gmail.com
Dr Manoj Murlidhar Toshniwal
Jeevan Amrut Hematology Centre India Private Limited
Consultation Room No. 2 , 1st floor, Deapartment of Haematology, Jeevan Amrut Hematology Centre India Private LimitedPlot No.47 Parijat Nagar, Near Gokul sweets, Sector N-4, CIDCO, Aurangabad – 431005, Maharashtra, India Aurangabad MAHARASHTRA
9907014104
contact@jeevanammrut.co.in
Dr V Sathya Prasad
King George Hospital
Rajendra Prasad ward, 1st Floor, Department of General Medicine, KGH Down Rd, Opp KGH OP Gate, Maharani Peta, Visakhapatnam, Andhra Pradesh 530002, India Visakhapatnam ANDHRA PRADESH
9393104578
drvsatyaprasadresearch@gmail.com
Dr Miteshkumar D Halvawala
Nirmal Hospital Pvt Ltd
Adult OPD Room No 112, 1st floor, Department of Haematology, Nirmal Hospital Pvt Ltd, Ring Road, Surat, Gujarat 395002 Surat GUJARAT
9825109995
dr.mitesh.55@gmail.com
Dr Tuphan Kanti Dolai
NRS Hospital Kolkata
Room 1, 4th floor, Centrary Buliding, Department of Haematology, 138, A.J.C Bose Road, Kolkata - 700014 Kolkata WEST BENGAL
9879890275
tkdolai@hotmail.com
Dr Sudhir Kumar
PGIMS
Ward No. 9, 2nd Floor, Near to MS Office, Department of Medicine, Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences, Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences Medical Road, Rohtak Haryana -124001. Rohtak HARYANA
9315895272
ssmantri74@yahoo.com
Dr Apte Shashikant Janardan
Sahyadri Super Specialty Hospital
OPD No. 05, Ground Floor, Department of Hematology and BMT., Sahyadri Super Specialty Hospital Deccan, Plot No. 30 C, Erandawane, Karve Road, Pune – 411004, Maharashtra, India. Pune MAHARASHTRA
OPD Room No. 36, 6th Floor, OPD Buliding, Near Silver Jubilee Block, Department of Clinical Haematology, St. Johns Medical College and Hospital, Sarjapur Road, Koramangala, Bangalore-560034, India Bangalore KARNATAKA
250 mcg of deliverable Romiplostim Lyophilized Powder for Solution for Injection in single dose vials will be supplied for subcutaneous administration once a week for 12 weeks.
The initial dose for Romiplostim will be 1 mcg per kg once weekly based on actual body weight.
Subsequent weekly doses will be on the increments of 1 mcg per kg until the patient achieves a platelet count greater than or equal to 50 X 10 to the power of 9 per L as necessary to reduce the risk for bleeding.
Intervention
Romiplostim
250 mcg of deliverable Romiplostim Lyophilized Powder for Solution for Injection in single dose vials will be supplied for subcutaneous administration once a week for 12 weeks.
The initial dose for Romiplostim will be 1 mcg per kg once weekly based on actual body weight.
Subsequent weekly doses will be on the increments of 1 mcg per kg until the patient achieves a platelet count greater than or equal to 50 X 10 to the power of 9 per L as necessary to reduce the risk for bleeding.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
Subjects will be enrolled in the study if they meet all the following criteria
1. Male and female subjects of age group 18 to 65 years (both inclusive).
2. Willing and able to provide a written informed consent.
3. Diagnosed with ITP based on the American Society of Haematology (ASH) guidelines.
4. Already received at least one prior treatment for ITP.
5. Subject greater than 60 years of age must have had a documented history of ITP with a confirmatory bone marrow report on the diagnosis.
6. Two weekly platelet count less than or equal to 30 X 10 to the power of 9 per L at any time during the screening period.
7. Haemoglobin greater than or equal to 9.0 g per decilitre
8. Patients who are willing and able to comply with all the study assessments and adhere to the protocol schedule.
ExclusionCriteria
Details
Subjects will be excluded from the study participation if they fall on any of the below criteria
1. Known history or presence of hypersensitivity reaction to any recombinant E.coli derived products.
2. History of haematological malignancy, myeloproliferative disorder, myelodysplastic syndrome (MDS), or bone marrow stem cell carcinoma
3. Known history of congenital thrombocytopenia, thromboembolic disease, systemic lupus erythematosus, Evans syndrome, or autoimmune neutropenia, antiphospholipid antibody syndrome or positive for lupus anticoagulant or autoimmune haemolytic anaemia
4. Known history of disseminated intravascular coagulation, haemolytic uremic syndrome, or thrombotic thrombocytopenic purpura.
5. Previous use of Romiplostim/ pegylated recombinant human megakaryocyte growth and development factor (PEG-rHuMGDF), TPO-RA drugs such as Eltrombopag, recombinant human thrombopoietin (rHuTPO) or any platelet producing agent
6. Currently receiving any treatment for ITP except corticosteroids, azathioprine, mycophenolate, cyclosporin, vincristine, and/or danazol administered at a constant dose and schedule.
7. 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.
8. 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.
9. Subjects with positive laboratory findings of hepatitis B, hepatitis C, or human immunodeficiency virus at screening
10. Known history of infection with H. pylori • Known case of chronic liver disease or hepatic impairment, defined as any serum bilirubin greater than or equal to 1.5 times laboratory normal range at screening
11. Any active malignancy, if prior history of cancer other than basal cell carcinoma or cervical carcinoma in situ, no treatment or active disease within 5 years before randomization
12. Female subjects of child-bearing potential not using adequate contraceptive precautions in the judgement of the investigator
13. Breast-feeding mothers or female subjects of child-bearing potential with positive urine pregnancy test at the time of screening
14. Less than 2 months since major surgery
15. Subjects involved in clinical trials and taken investigational drugs within 30 days of enrolment
16. Creatinine clearance or calculated creatinine clearance less than 45 mL per minute (Cockcroft-Gault Equation).
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Double Blind Double Dummy
Primary Outcome
Outcome
TimePoints
Proportion of patients achieving platelet response (i.e., greater than or equal to 50 X 10 to the power of 9 per L) for any 4 weeks of the 12 weeks of treatment with biosimilar Romiplostim treatment compared to Nplate
12 weeks (Every week including baseline)
Secondary Outcome
Outcome
TimePoints
Proportion of patients receiving rescue medications that is Corticosteroids, IVIG, Anti D immunoglobulin, Platelet transfusions etc. during the treatment period, compared to Nplate
Number of weekly Platelet Responses defined as a platelet count of greater than or equal to 50 X 10 to the power of 9 per L on the weekly scheduled dose day from week 1 to week 12 inclusive compared to Nplate
Presence of Anti-Romiplostim Antibodies, compared to Nplate
Incidence of Treatment-Emergent Adverse Events TEAEs & Serious Adverse Events SAEs during the treatment period related to biosimilar Romiplostim or Nplate
Clinical chemistry, haematology, urine analysis & other laboratory findings during the 13 weeks, compared to Nplate.
Single-dose pharmacokinetic PK parameters AUC0-t Cmax & Tmax of Romiplostim biosimilar compared to Nplate
Platelet Responses - Every week (Including baseline).
Presence of Anti-Romiplostim Antibodies - baseline & week 13.
Total Sample Size="72" Sample Size from India="72" 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)
22/12/2025
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="0" Months="3" Days="21"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Open to Recruitment
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This is a prospective, randomized, double-blind, multi-centre, parallel arm clinical trial to assess the efficacy and safety of a Romiplostim Biosimilar manufactured by Levim Lifetech Private Limited compared to Nplate (Romiplostim) manufactured by Amgen in patients with immune thrombocytopenia (ITP). Conducted across 15 sites in India, the trial aims to recruit 72 subjects, with a randomization ratio of 3 is to 1 favoring the biosimilar.
The primary objective is to compare the platelet response (greater than or equal to 50 X 10 to the power of 9 per L) between both treatments over a 12-week period. Secondary objectives include analyzing safety through adverse events, measuring the presence of anti-romiplostim antibodies, and assessing pharmacokinetics. The study recognizes ITP as a rare condition with unmet medical needs, justifying the trial for its biosimilar. Each participant’s total study duration is 16 weeks, which includes 2 weeks of screening and 12 weeks of treatment. Ethical compliance will align with ICH-GCP guidelines and local regulations to ensure patient safety and data integrity throughout the study