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CTRI Number  CTRI/2023/05/053181 [Registered on: 29/05/2023] Trial Registered Prospectively
Last Modified On: 05/03/2024
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   The study is to check the safety and effectiveness of romiplostim in patients suffering from severe purple discoloration of skin due to low platelets. 
Scientific Title of Study   A phase IV, open-label, single-arm, multi-center clinical study to evaluate the safety and efficacy of romiplostim in patients with chronic immune thrombocytopenic purpura.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
ALK24/ROMI2, Version 1.0, Date: 15 Feb 2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Milan Satia 
Designation  CEO 
Affiliation  Ethicare Clinical Trial Service 
Address  Titanium City Centre, Block "G" 410-412, Nr. Sachin Tower, 100 Ft.Road, Satellite. Ahmadabad GUJARAT Ahmadabad GUJARAT 380015 India

Ahmadabad
GUJARAT
380015
India 
Phone  9825585119  
Fax    
Email  milansatia@ethicare-cro.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Milan Satia 
Designation  CEO 
Affiliation  Ethicare Clinical Trial Service 
Address  Titanium City Centre, Block "G" 410-412, Nr. Sachin Tower, 100 Ft.Road, Satellite. Ahmadabad GUJARAT Ahmadabad GUJARAT 380015 India


GUJARAT
380015
India 
Phone  9825585119  
Fax    
Email  milansatia@ethicare-cro.com  
 
Details of Contact Person
Public Query
 
Name  Dr Milan Satia 
Designation  CEO 
Affiliation  Ethicare Clinical Trial Service 
Address  Titanium City Centre, Block "G" 410-412, Nr. Sachin Tower, 100 Ft.Road, Satellite. Ahmadabad GUJARAT Ahmadabad GUJARAT 380015 India


GUJARAT
380015
India 
Phone  9825585119  
Fax    
Email  milansatia@ethicare-cro.com  
 
Source of Monetary or Material Support  
Alkem Laboratories Limited Alkem House, “Devashish”, Adjacent to Matulya centre, Senapati Bapat Marg, Lower Parel, Mumbai – 400 013 
 
Primary Sponsor  
Name  Alkem Laboratories Limited 
Address  ALKEM HOUSE, “Devashish”, Adjacent to Matulya centre, Senapati Bapat Marg, Lower Parel, Mumbai – 400 013 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NA  NA 
 
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 Richa Giri  GSVM Medical college  Ward no. 06, near septic OT, Swaroop Nagar, Kanpur, Uttar Pradesh
Kanpur Nagar
UTTAR PRADESH 
8400331045

krricha227@gmail.com 
Dr Sanket Shah  Hemato Oncology Clinic Ahmedabad Pvt .Ltd  Hemato Oncology Clinic Ahmedabad Pvt .Ltd “Vedanta Institute of Medical Science, First Floor, Nr. Samved Hospital Stadium Commerce Road, Navrangpura,Ahmedbad-380009
Ahmadabad
GUJARAT 
9909908620

drsanket2086@gmail.com 
DrHollis Dsouza  Kkasturi Medicare pvt Ltd   Kkasturi Medicare pvt Ltd 3rd floor Clinical research Room, Harsh Niketan, Gaodevi Road, behind Navrang Hotel Oppsite, Bhayandar, Mira Gaothan, Geeta Nagar, Bhayandar West, Mira Bhayandar, Maharashtra 401101
Mumbai
MAHARASHTRA 
8356003006

drhollisdsouza04@gmail.com 
DrAbhijeet Ganapule   Niche Hematology Centre  Niche Hematology Centre, 1st floor, vasant pride, 8th Ln, opposite City Hosptal, Poorvarang, Mahalaxminagar, Rajarampuri, Kolhapur, Maharashtra 416008
Kolhapur
MAHARASHTRA 
9500817639

abhiganapule@gmail.com 
Dr Kalpesh Prajapati  OHM Hospital  41/A Karmachari Nagar-1, opp Alkapuri Society, Bhayandev, Ghatlodia road, Ahmedabad 380061
Ahmadabad
GUJARAT 
9909914228

Drkkp23@gmail.com 
Dr Himal Shah   Qure hematology and oncology center  Room no 05 Qure Hematology And Oncology Center , Kedar Building, 301, Sheth Mangaldas rd, Near Parimal garden, Ellis bridge, Ahmedabad, Gujarat, 380006
Ahmadabad
GUJARAT 
9099923281

drhimalshah@gmai.l.com 
DrKeyur Bhrame  SSG hospital  Near Kala Godha Circle, Opposite OPD 09, Aradhana Cinema, Jail Road, Raopura-390001 , Vadodara
Vadodara
GUJARAT 
9727729105

keyurbrahme@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 7  
Name of Committee  Approval Status 
GSVM Medical College Ethic Committee  Approved 
Institutional Ethics Committee for Human Research Medical College Baroda (IECHR)  Approved 
Riddhi Medical Nursing home institutional Ethics Committee - DrHimal  Approved 
Riddhi Medical Nursing Home IEC  Approved 
Riddhi Medical Nursing Home Institutional Ethics Committee-Dr Kalpesh  Approved 
Shah Lifeline Hospital & Heart Institute Ethics Committee  Approved 
Shreyas Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI
Modification(s)  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D693||Immune thrombocytopenic purpura,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NA  NA 
Intervention  Romiplostim 250 mcg  Romiplostim 250 mcg lyophilised powder for solution for injection through SC injection once a week for 12 weeks. The initial dose for Romiplostim will be 1 mcg/kg based on actual body weight and then weekly dose of Romiplostim will be adjusted by increments of 1 mcg/kg until the patient achieves a platelet count more than equal to 50 x 10 raise to 9 /L.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1) Male and Female subject in between 18 to 65 years of age.
2) Patients with chronic immune (idiopathic) thrombocytopenic purpura. per the American Society of Hematology guidelines.
3) If subject is > 60 years of age, subject had a written bone marrow biopsy report consistent with a diagnosis of ITP.
4) Subject had received at least 1 prior therapy for ITP.
5)Subject with a single platelet count less than equal to 30 x 10 raise to 9/L at any time during the screening period.
6) Subject (or legally - acceptable representative) was willing and able to
provide written informed consent. 
 
ExclusionCriteria 
Details  1) Known hypersensitivity to romiplostim or any of its excipients.
2) Subject had a history of hematological malignancy, myeloproliferative disorder, myelodysplastic syndrome (MDS), or bone marrow stem cell
disorder.
3) Subjects with known history of congenital thrombocytopenia, systemic lupus erythematosus, Evans syndrome, autoimmune neutropenia,
antiphospholipid antibody syndrome, positive for lupus anticoagulant, disseminated intravascular coagulation, hemolytic uremic syndrome, or thrombotic thrombocytopenic purpura.
4) Subjects with known history of infection with H. pylori.
5) Previous use of romiplostim, pegylated recombinant human megakaryocyte growth and development factor (PEG-rHuMGDF), Eltrombopag, recombinant human thrombopoietin (rHuTPO) or any
platelet producing agent.
6) Subject has a known hypersensitivity to any recombinant E coli-derived product.
7) Subjects suffering from chronic liver disease (Child-Pugh score more than or equal to 7).
8) Subjects with history of any thromboembolic disease.
9) Subject is of reproductive potential and is not using adequate contraceptive precautions, in the judgment of the investigator.
10) Subject is pregnant or breast feeding.
11) Any significant medical condition in the opinion of the investigator that does not allow the participation of the patient in the study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Number of AEs (adverse events) and Number of adverse drug
reactions (ADRs) during the study period 
14 weeks
 
 
Secondary Outcome  
Outcome  TimePoints 
Number of serious adverse events (SAEs) and serious adverse drug reactions (SADRs) during the study period.  14 weeks

 
Proportion of patients achieving platelet response (achievement of a weekly platelet count more than or equal to 50 x 10 raise to 9 /L)  14 weeks 
 
Target Sample Size   Total Sample Size="25"
Sample Size from India="25" 
Final Enrollment numbers achieved (Total)= "22"
Final Enrollment numbers achieved (India)="22" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)
Modification(s)  
20/06/2023 
Date of Study Completion (India) 04/05/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="9"
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)?  

Response - NO
Brief Summary  

This study will be conducted to evaluate the safety and efficacy of romiplostim in patients with chronic immune thrombocytopenic purpura. Sufficient number of patients will be enrolled in the study to get 25 evaluable subjects. Patient’s who meet all inclusion criteria and none of the exclusion criteria based on medical history will be recruited in the study. Patient’s visit 1 will be screening visit followed by treatment period and last will be follow up period for 1 week after last dose.

The eligible patient’s will be injected subcutaneously with initial dose for Romiplostim 1 mcg/kg based on actual body weight and then the weekly dose of Romiplostim will be adjusted by increment of 1 mcg/kg until the patient achieves a platelet count more than or equal to 50 count once a week for 12 cycles. The primary endpoint will be number of AEs (adverse events) and number of adverse drug reactions (ADRs) during the study period. The secondary endpoint will be number of serious adverse events (SAEs) and serious adverse drug reactions (SADRs) during the study period and proportion of patients achieving platelet response (achievement of a weekly platelet count more than or equal to 50 x 10 raise to 9 /L).

 
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