| CTRI Number |
CTRI/2023/04/051785 [Registered on: 19/04/2023] Trial Registered Prospectively |
| Last Modified On: |
12/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An observational study of Livogen Z tablet in patients with iron deficiency anemia |
|
Scientific Title of Study
|
Evaluation of the effectiveness of Livogen Z®
(Ferrous Fumarate,
Folic Acid and Zinc Sulphate) Fixed Dose Combination in Iron
Deficiency Anemia – An Open Label, Single arm, Phase IV, PostMarketing, Observational Study (LIBERTY) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CSD2021008, Version 1.0 dated 02-Dec-2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Poonam Sule |
| Designation |
Senior Clinical Manager |
| Affiliation |
Procter & Gamble Health Limited |
| Address |
Ground floor and First Floor P&G Plaza
Cardinal Gracious Road Chakala
Andheri (East)
Mumbai (Suburban)
MAHARASHTRA
400099
India |
| Phone |
09619207436 |
| Fax |
|
| Email |
sule.p@pg.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Poonam Sule |
| Designation |
Senior Clinical Manager |
| Affiliation |
Procter & Gamble Health Limited |
| Address |
Ground floor and First Floor P&G Plaza
Cardinal Gracious Road Chakala
Andheri (East)
Mumbai (Suburban)
MAHARASHTRA
400099
India |
| Phone |
09619207436 |
| Fax |
|
| Email |
sule.p@pg.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Poonam Sule |
| Designation |
Senior Clinical Manager |
| Affiliation |
Procter & Gamble Health Limited |
| Address |
Ground floor and First Floor P&G Plaza
Cardinal Gracious Road Chakala
Andheri (East)
Mumbai (Suburban)
MAHARASHTRA
400099
India |
| Phone |
09619207436 |
| Fax |
|
| Email |
sule.p@pg.com |
|
|
Source of Monetary or Material Support
|
| Procter & Gamble Health Ltd. |
|
|
Primary Sponsor
|
| Name |
Procter and Gamble Health Limited |
| Address |
Ground floor and First Floor
Procter and Gamble Plaza
Cardinal Gracious Road Chakala
Andheri Mumbai 400099
Maharashtra |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ravindra Pukale |
Adichunchanagiri Hospital & Research Centre |
BG Nagar, Mandya, Bangalore, Karnataka - 571418
Bangalore
KARNATAKA |
09449751733
ravindrapukale@yahoo.com |
| Dr Parag Biniwale |
Biniwale Womens Clinic |
Flat no: 8, Second floor, 1202/2A/4, Apte Road, Dream Residency, Shivaji Nagar, Pune, Maharastra - 411005.
Pune
MAHARASHTRA |
8600973116
parag.biniwale@gmail.com |
| Dr Lakshmi Swetha Karlapudi |
Sanjeevani Hospital |
DP Road, Parijat Colony, Gadital, Hadapsar, Pune, Maharastra - 411028.
Pune
MAHARASHTRA |
08975068940
drlakshmikarlapudi.pi@gmail.com |
| Dr Nimisha Pagare |
Srushti Hospital and Maternity Home |
27 A Nandigram Colony, Pundalik Nagar Road, Near Essar Petrol bunk, Garkheda, Aurangabad - 431001.
Aurangabad
MAHARASHTRA |
07028931524
drnimishapagare.pi@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of AH and RC |
Approved |
| Royal Pune Independent Ethics committee |
Approved |
| Royal Pune Independent Ethics committee |
Approved |
| Royal Pune Independent Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D50||Iron deficiency anemia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Livogen Z® tablets
|
Dose: 1 Tablet twice daily,
Duration - 90 days (3 months)
Route: Oral,
Fixed Dose Combination consist of:
Ferrous Fumarate IP - 152 mg
Equivalent to 50 mg elemental iron
Folic acid IP - 750 mcg
Zinc sulphate Monohydrate USP - 61.8 mg
(Equivalent to elemental Zinc - 22.5 mg) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
1. Female subjects with known IDA as per WHO criteria to whom Livogen Z® will be prescribed per routine clinical practice of the investigator.
IDA as per WHO criteria
1. Non-Anemia (g. dL)
a. Non-pregnant women (age > 15 years or above) ≥ 12 or higher
b. Pregnant women (age > 15 years or above) ≥ 11 or higher
2. Anemia (g. dL)
A. Non-pregnant women (age > 15 years or above)
a. Mild (Non-pregnant women) 11 to 11.9
b. Moderate (Non-pregnant women) 8 to 10.9
c. Severe (Non-pregnant women) Lower than 8
B. Pregnant women (age > 15 years or above)
a. Mild (Pregnant women) 10 to 10.9
b. Moderate (Pregnant women) 7 to 9.9
c. Severe (Pregnant women) < 7
2. Subjects willing to provide written informed consent
3. Subject aged > 18 to ≤ 55 years
4. Subjects willing to comply with the prescribed treatment regimen for the duration of study participation. |
|
| ExclusionCriteria |
| Details |
Subjects will be excluded if they meet any of the following criteria:
1. Subjects with a severe case of anemia requiring blood transfusions.
2. Subjects with anemia, which in the opinion of the investigator is caused by known conditions other than dietary deficiency including:
a. Pernicious anemia
b. Thalassemia
c. Sickle cell or aplastic anemia
d. Active peptic ulcer
e. Regional enteritis
f. Ulcerative Colitis
g. Hemorrhoids
h. Esophageal varices
i. Helminthiasis
j. Megaloblastic anemia
k. Porphyria cutanea tarda
3. Subjects with folate dependent tumours.
4. Subjects with serious gastrointestinal disorders,(e.g., inflammatory bowel disease,
intestinal strictures and diverticulae), who cannot take iron therapy by mouth.
5. Subjects with any known autoimmune disease.
6. Malnourished subjects who also have a known underlying infection that interferes with iron absorption.
7. Subjects with primary or secondary hemochromatosis or who are known to have a risk for iron overload.
8. Subjects with IDA in whom oral therapy has failed in clinical practice.
9. Subjects with an acute bleeding condition.
10. Subjects who have become pregnant with assisted reproduction technology (like In-vitro Fertilization (IVF), etc.)
11. Pregnant subjects in their third trimester gestation week 27 onwards.
12. Pregnant subjects with gestational diabetes or hypertension.
13. Subjects with bleeding disorders. (e.g. blood dyscrasia, subjects with hemophilia, thrombocytopenia, low platelets, coagulopathy, etc.)
14. Subjects suffering from severe or uncontrolled systemic or metabolic diseases.
15. Pregnant subjects with multifetal pregnancy.
16. Subjects who have taken hematinic agents (except Livogen Z®) /supplements
continuously for two weeks with a daily dose of elemental iron ≥27 mg in pregnant subjects, ≥18mg in non-pregnant subjects and within 4 weeks prior to study start.
17. Subjects with severe concurrent illness (cardiovascular, renal, hepatic), and with any
other condition that in the opinion of the investigator does not justify the inclusion of
the subject in the study.
18. Subject whose lifestyle (including diet and food intake) would, in the Investigator’s
judgment, affect the subject’s participation in the study.
19. Subjects who have participated in any other clinical trial in the past 30 days from the study start. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in hemoglobin concentration from baseline visit (Visit 1) |
90 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in hemoglobin concentration from baseline visit (Visit 1) |
Days 21±7, and 60 ± 3 days |
| Change from baseline (Visit 1) in serum ferritin concentration at EOS. |
EOS |
Assessment of adverse events, GI tolerability and product acceptability.
|
EOS |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "102"
Final Enrollment numbers achieved (India)="102" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
24/04/2023 |
| Date of Study Completion (India) |
05/10/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="11"
Days="30" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a single-arm, open-label, multicenter, prospective observational study. A total of 100 patients with Iron Deficiency Anaemia (IDA) will be enrolled in the study. The duration of the study for each participant will be up to 3 months (90 Days). During a routine consultation, subjects will be recruited as per the protocol eligibility criteria. The aim of this study is to evaluate the changes in hemoglobin among subjects with IDA after 90 days of treatment with Livogen Z® or the last post-baseline hemoglobin assessment. |