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, “Devashishâ€, Adjacent to Matulya centre, Senapati Bapat Marg, Lower Parel, Mumbai – 400 013 |
|
Primary Sponsor
|
Name |
Alkem Laboratories Limited |
Address |
ALKEM HOUSE, “Devashishâ€,
Adjacent to Matulya centre, Senapati Bapat Marg,
Lower Parel, Mumbai – 400 013 |
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 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)
|
|
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). |