| CTRI Number |
CTRI/2024/02/062551 [Registered on: 12/02/2024] Trial Registered Prospectively |
| Last Modified On: |
15/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Bioequivalence study of Ferric carboxymaltose solution in patients with iron deficiency anemia. |
|
Scientific Title of Study
|
A multicenter, open label, balanced, randomized, single-dose, two-treatment, single period, parallel bioequivalence study of Ferric carboxymaltose solution for injection 750mg per 15 mL -50 mg iron per mL of DifGen Pharmaceuticals LLC, with that of INJECTAFER Ferric carboxymaltose solution for injection 750mg per 15 mL - 50 mg iron per mL ] of American Regent, Inc. - USA in patients with iron deficiency anemia under fasting condition. |
| Trial Acronym |
23-VIN-0413 |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| 23-VIN-0413 version 1.1 dated 21 Feb 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rakesh Patel |
| Designation |
Head Projects |
| Affiliation |
Veeda Clinical Research Limited |
| Address |
Veeda Clinical Research Ltd., Shivalik Plaza, Near I.I.M., Ambawadi, Ahmedabad
Ahmadabad
GUJARAT
380015
India |
| Phone |
8308843660 |
| Fax |
|
| Email |
rakesh.patel@veedacr.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravi Alamchandani |
| Designation |
General Manager |
| Affiliation |
Veeda Clinical Research Limited |
| Address |
Veeda Clinical Research Ltd., Shivalik Plaza, Near I.I.M., Ambawadi, Ahmedabad
Ahmadabad
GUJARAT
380015
India |
| Phone |
9687306158 |
| Fax |
|
| Email |
Ravi.A1950@veedacr.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ravi Alamchandani |
| Designation |
General Manager |
| Affiliation |
Veeda Clinical Research Limited |
| Address |
Veeda Clinical Research Ltd., Shivalik Plaza, Near I.I.M., Ambawadi, Ahmedabad
Ahmadabad
GUJARAT
380015
India |
| Phone |
9687306158 |
| Fax |
|
| Email |
Ravi.A1950@veedacr.com |
|
|
Source of Monetary or Material Support
|
| DifGen Pharmaceuticals LLC |
|
|
Primary Sponsor
|
| Name |
DifGen Pharmaceuticals LLC, |
| Address |
100 overlook center suite 2099,
Princeton,
New Jersey 08540 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Veeda Clinical Research Limited |
Shivalik Plaza, Near I.I.M., Ambawadi Ahmedabad – 380 015, India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jitendra Anand |
Anand Multi Speciality Hospital and Research Centre |
4th Floor, Sarthak Mall, Mahatma Mandir Road, Sargasan cross Road, Gandhinagar 382421
Gandhinagar
GUJARAT |
9824017101
jkanand09@gmail.com |
| Dr Bhargav Solanki |
Global Hospital |
Behind Auda Garden, Bodakdev, Pakwan Cross Road Off S.G Highway Bodakdev
Ahmadabad
GUJARAT |
7984732820
1985bhargav@gmail.com |
| Dr ilesh Patel |
Kanoria Hospital Research Center |
Airpot Road Gandhinagar Highway Village Bhat Dist. Gandhinagar 382428
Gandhinagar
GUJARAT |
9558806751
ilesh16@gnail.com |
| Dr smit shah |
Matis Multispeciality Hospital |
Opposite Adani CNG GAS station near Matera BRTS Bus stop , Motera Cross Road Ahmedabad Gujarat 380005
Ahmadabad
GUJARAT |
7405310006
contactsmit@gmail.com |
| Dr Ramanbhai Patel |
Namostute Hospital |
Plot No 1285, Sector 6-D, GH - 3 Circle Opposite Civil Hospital
Gandhinagar
GUJARAT |
9898205641
drramanpatel22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Anand Ethics Committee Anand Multispecialty Hospital and Research Centre 4th Floor, Sarthak Mall, Mahatma Mandir Road Sargasan Cross Road Gandhinagar Gandhinagar Gujarat - 382421 India - Dr. Jitendra Anand |
Approved |
| Kanoria Ethics Committee Kanoria Hospital And Research Centre Kanoria Hospital And Research Centre, Airport- Gandhinagar Highway, Village-Bhat Gandhinagar Gandhinagar Gujarat - 382428 India - Dr Ilesh Patel |
Submittted/Under Review |
| Shakti Hospital Ethics Committee Shakti General Hospital A116,117,118 And A 102,103,105 FF Krishna Complex Nr Shahwadi Bus Stand,Narol Ahmedabad Ahmedabad Gujarat - 382405 India - Dr Bhargav Solanki |
Approved |
| Shakti Hospital Ethics Committee Shakti General Hospital A116,117,118 And A 102,103,105 FF Krishna Complex Nr Shahwadi Bus Stand,Narol Ahmedabad Ahmedabad Gujarat - 382405 India - Dr Smit Shah |
Submittted/Under Review |
| The Chairman IEC, Shashvat Surgicare Hospital Shashvat Surgicare Hospital Plot No. 3, 4, 4th Floor Room No. 401, Shyam Residency, Kudasan Gandhinagar Gandhinagar Gujarat - 382421 India - Dr. Ramanbhai Patel |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D509||Iron deficiency anemia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ferric carboxymaltose solution for injection 750mg per 15 mL -50 mg iron per mL |
On day 1, Patients will receive single dose - 750 mg of either test or reference product i.e. Ferric carboxymaltose solution for injection 750mg per 15 mL |
| Comparator Agent |
INJECTAFER - Ferric carboxymaltose solution for injection 750mg per 15 mL -50 mg iron per mL |
On day 1, Patients will receive single dose - 750 mg of either test or reference product i.e. Ferric carboxymaltose solution for injection 750mg per 15 mL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and female patients with age 18-65 years -inclusive of both
2. Patients with more than or equal 50 kg body weight and weight within the clinically acceptable normal range according to normal values for Body Mass Index -18.50 to 24.90 kg per m2 both inclusive.
3. Patients that have Iron Deficiency Anemia -IDA at the time of screening based on the following laboratory parameters:
a. Hemoglobin value less than 7 and more than 12 g per dL at screening.
b. Ferritin less than or equal to 100 ng per mL or less than or equal to 300 ng per mL when transferrin saturation -TSAT is less than or equal to 30% at screening.
4. Patients that meet either of the following criteria:
Unsatisfactory response to oral iron in the opinion of the Investigator based on the history of having received oral iron therapy.
Intolerance to oral iron preparations or where oral iron preparations cannot be used as per the Investigator.
5. Patients requiring total iron of at least 750 mg based on individual assessment of iron deficiency by the Investigator.
6. Patients with a prescription for treatment with ferric carboxymaltose injections prior to randomization in the study.
7. Patients willing to adhere to the protocol requirements and to provide written informed consent.
8. Patients can understand and comply with the study procedures, in the opinion of the investigator.
9. For Female patients:
Female of childbearing potential having negative Serum β-hCG (pregnancy test) at screening and Urine Pregnancy test at admission and practicing an acceptable method of birth control for the duration of the study as judged by the investigator s , such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence, OR
Postmenopausal for at least 01 years from the last menstrual date, OR
Surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject).
|
|
| ExclusionCriteria |
| Details |
Patients will be excluded from the study, if they meet any of the following criteria:
1. Ongoing pregnancy or lactation or nursing females.
2. Known hypersensitivity to Investigational Medicinal Product, excipients, or other parenteral iron products.
3. History of:
Anaemia not caused by iron deficiency - e.g., aplastic, megaloblastic or hemolytic anemia, sideroblastic anemia or related to acute or ongoing, hemoglobinopathies, rheumatic and other chronic diseases like CKD, autoimmune diseases, malignancies, bone marrow diseases, enzyme defects, and drug induced anemia.
Known allergies including drug allergies, including patients with a history of severe asthma, eczema or other atopic allergy.
Haemochromatosis or other iron storage or disturbances in the utilization of iron disorders or evidence of iron overload.
Clinically significant - systolic more than 160 and or diastolic more than 100 or labile hypertension Any ongoing acute or chronic infection or ongoing bacteremia at screening.
Any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardize the patient’s safety or compliance with the protocol.
Alcoholism or drug abuse, or severe emotional, behavioral or psychiatric problems within 6 months before screening, who may not be able to adequately comply with the requirements of the study.
Any active malignancy within 5 years before screening.
4. Known:
Significant comorbidities like major cardiovascular disease uncontrolled endocrinological or metabolic disorders; malignancy, active renal disease, active liver disease, active peptic ulcer, asthma, or rheumatoid arthritis.
Liver dysfunctions including particular Porphyria Cutanea Tarda - PCT or elevated serum transaminases to more than three times the upper limit of normal - ULN
HIV positive or Acquired Immune Deficiency Syndrome -AIDS related illness, or HIV seropositivity at screening.
Active or chronic Hepatitis B or Hepatitis C infection, or Hepatitis B and or Hepatitis C seropositivity at screening, if not related to vaccination.
Bleeding disorders; acute bleeding or recently documented hemorrhage or recent blood loss leading to hemodynamic instability within 3 months before screening.
5. Receipt of:
Medications (Refer Annexure III) that may affect PK results within 14 days before enrolment.
Oral iron supplementation within the past 14 days before screening and prior to dosing.
Blood transfusion within 3 months before screening, or anticipated need for a blood transfusion during the study.
Parenteral iron therapy within the last 6 months before screening.
Erythropoietin/Erythroid Stimulating Agent treatment within 6 months before screening.
6. Patients who are on sodium controlled diet.
7. Donation of blood (1 unit or 350 mL) within 90 days before receiving the single dose of IMP.
8. Inadequate venous access for PK sampling as judged by the investigator.
9. Requirement of any planned procedure or hospitalization for pre-existing conditions during the study period.
10. Patients were found positive on a urine scan for drugs of abuse and/or breath test for alcohol consumption at screening and at the time of check-in and drinking more than five cups of xanthine-containing beverages per day.
11. The receipt of an investigational medicinal product or participation in other drug research study within a period of 30 days (or 5 half-lives, whichever is longer) before the first dose of an investigational medicinal product for the current study.
Note: The elimination half-life of the study drug should be taken into consideration for the inclusion of the patient in the study.
12. Abnormal baseline laboratory/physical findings are considered to be clinically significant by the investigator.
13. Patients with any significant history of non-compliance or inability to reliably grant informed consent.
|
|
|
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 |
| To assess the bioequivalence of Ferric carboxymaltose solution for injection 750mg per 15 mL- 50 mg iron per mL against INJECTAFER in patients with iron deficiency anemia for whom oral supplementation alone was not adequate or is not appropriate under fasting conditions. |
A total of 31 blood samples will be collected during study.
The blood samples of 05 mL each will be collected at -24.000 and
-12.000 hours before initiation of IMP injection
The blood samples -28 time points for PK analysis will be collected after start of infusion. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To monitor the safety and tolerability profile of the study formulations. |
A total of 31 blood samples will be collected during study.
The blood samples of 05 mL each will be collected at -24.000 and
-12.000 hours before initiation of IMP injection
The blood samples -28 time points for PK analysis will be collected after start of infusion.
|
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
Final Enrollment numbers achieved (Total)= "104"
Final Enrollment numbers achieved (India)="104" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
20/02/2024 |
| Date of Study Completion (India) |
13/05/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="22" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
The Study consist of single period, patient will receive either test / reference [ferric carboxymaltose solution for injection/infusion (50 mg iron/mL)] as per randomization schedule on dosing day, A total of 31 blood samples will
be collected during study.
The blood samples (03-time points including
pre-injection blood sample) of 05 mL each will be collected at -24.000 and
-12.000 hours before initiation of IMP injection with an allowable deviation of
±5 minutes and 0.000 hours within -5 minutes before initiation of IMP undiluted
as a slow intravenous injection.
The blood samples (28-time points)
of 05 mL each (except *04 mL for the marked time points) for PK analysis will
be collected at 0.083 (5 min), 0.133 (8 min) 0.250 (15 min) 0.500 (30 min),
0.750 (45 min), 1.000, 1.250, 1.500, 1.750, 2.000, 3.000, 4.000, 6.000, 8.000,
10.000, 12.000, 16.000, 24.000, 36.000, 48.000, 60.000, 72.000, 96.000 (Day 5),
120.000 (Day 6), 144.000 (Day 7), 168.000 (Day 8), 216.000* (Day 10) and
264.000* (Day 12) hours after start of infusion.
Note: 04 mL blood will be
collected to following time points: 216.000 (Day 10) and 264.000 (Day 12) hours
after start of infusion.
Note: A deviation of ±1 minutes will be allowed for post-dose samples up to
1.000 hrs. and a deviation of ±2 minutes will be allowed for post-dose samples
up to 72.000 hrs. The ambulatory samples scheduled at
and after 96.000 hrs. will be collected with an allowable deviation of ±2 hrs.
Different arms will be used for
injection and blood withdrawal (of PK samples). Baseline samples (-24.000,
-12.000) hours will be collected via fresh vein puncture. Samples from 0.000 to
24.000 hrs. will be collected from an indwelling cannula placed in a forearm
vein. If required, it may also be collected through a fresh vein puncture. The
heparin-lock technique will be used to prevent the clotting of blood in the
indwelling cannula. Before each blood sample is drawn via the indwelling
cannula, 0.5 mL of blood will be discarded to prevent the saline-diluted blood
and heparin from interfering with the analysis. Blood samples after 24 hours
will be collected through a fresh vein puncture. |