| CTRI Number |
CTRI/2025/08/092490 [Registered on: 06/08/2025] Trial Registered Prospectively |
| Last Modified On: |
14/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A research study to see how safe is eptacog alfa when used to stop heavy bleeding
in women after giving birth in India |
|
Scientific Title of Study
|
Safety of Eptacog Alfa in Severe Postpartum Haemorrhage in India: A Phase IV Interventional Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NN7711-7717 Version 4.0 Dated 11 September 2024 |
Protocol Number |
| U1111-1289-2568 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
|
| Affiliation |
|
| Address |
|
| Phone |
|
| Fax |
|
| Email |
|
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Vijay Parthasarathy |
| Designation |
Director, CDC India |
| Affiliation |
Novo Nordisk India Private Ltd. |
| Address |
NXT-2, 1 & 2nd Floor, Embassy Manyata Business Park Nagavara Village, Kasaba Hobli
Bangalore
KARNATAKA
560045
India |
| Phone |
9911497869 |
| Fax |
|
| Email |
VJYP@novonordisk.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Vijay Parthasarathy |
| Designation |
Director, CDC India |
| Affiliation |
Novo Nordisk India Private Ltd. |
| Address |
NXT-2, 1 & 2nd Floor, Embassy Manyata Business Park Nagavara Village, Kasaba Hobli
Bangalore
KARNATAKA
560045
India |
| Phone |
9911497869 |
| Fax |
|
| Email |
VJYP@novonordisk.com |
|
|
Source of Monetary or Material Support
|
|
Novo Nordisk AS Novo Allé, 2880 Bagsvaerd Denmark |
|
|
Primary Sponsor
|
| Name |
Novo Nordisk India Pvt Ltd |
| Address |
NXT-2, 1 and 2nd Floor, Embassy Manyata Business Park Nagavara, Village, Kasaba Hobli Banglore Karnataka -560045 India |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jyothi Chandran |
Institute of Maternal and Child Health Government Medical College Kozhikode |
Institute of Maternal and Child Health, Government Medical College Kozhikode, Medical College Junction, Mavoor Rd, Kozhikode, kerala-673008
Kozhikode
KERALA |
9995353512
drjyotichandran@gmail.com |
| Dr Hema Patil |
KLES Dr. Prabhakar Kore Hospital and MRC |
KLES Dr. Prabhakar Kore Hospital and MRC, Nehru Nagar, Belagavi.
Belgaum
KARNATAKA |
9164342888
hemabanad@gmail.com |
| Dr Asha Verma |
S.M.S. Medical College and Attached Hospitals |
S.M.S. Medical College and Attached Hospitals,
J.L.N. Marg Jaipur Rajasthan - 302004
Jaipur
RAJASTHAN |
9413350927
ashavermacb@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Ethics Committee S.M.S. Medical College and Attached Hospitals. |
Submittted/Under Review |
| Institutional Ethics Committee, Government Medical College Kozhikode. |
Approved |
| Institutional Ethics Committee, KAHER, Belagavi |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O72||Postpartum hemorrhage, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Eptacog Alfa |
Eptacog alfa (activated) is authorised under the brand name NovoSeven® in India for sPPH (Severe Postpartum Haemorrhage) and is indicated for the treatment of bleeding episodes and for the prevention of bleeding in those undergoing surgery or invasive procedures |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
1.Informed consent1 obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study except for blood loss estimation post-partum 2. Adult women aged more than or equal to 18 years at the time of signing the informed consent and who deliver after 27 weeks diagnosed with severe PPH who fail to respond to uterotonics. patients to have uterotonics failure i.e. patients in whom uterotonics were insufficient to attain haemostasis and for definition of severe PPH. |
|
| ExclusionCriteria |
| Details |
1 Previous participation in this study. Participation is defined as having given informed consent in this study
2 Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
3 Patient with a history of thromboembolism2
4 Patient with a history of bleeding disorders3
5 Patient with a history of or ongoing disseminated intravascular coagulation (DIC); haemolysis, elevated liver enzymes, low platelet count (HELLP) syndrome, thrombotic thrombocytopenic purpura (TTP), pre-eclampsia or other severe complication of childbirth apart from severe PPH.
6 Have undergone invasive obstetric procedures for the ongoing haemorrhage prior to trial enrolment (uterine balloon tamponade and external aortic compression not included)
7 Any chronic disorder or severe disease which, in the opinion of the Investigator, might jeopardise patient’s safety or compliance with the protocol
8 Participation (i.e., signed informed consent) in any other interventional clinical study prior to screening in the current study
1Note: The patient’s legally acceptable representative (LAR) may be approached to obtain the informed consent if the patient is not in an appropriate health condition to provide consent. In a scenario where the LAR has provided informed consent, an additional informed consent will be obtained from the patient as soon as she is able to provide informed consent.
Includes arterial and venous thrombosis including myocardial infarction, pulmonary embolism, cerebral infarction/thrombosis, deep vein thrombosis, other clinically significant thromboembolic events, and peripheral artery occlusion.
Patient with a history of known inherited or acquired coagulation disorder other than PPH. Factor deficiencies such as haemophilia, acquired haemophilia, von Willebrand disease, other factor deficiencies and platelet disorders. These can also include qualitative and quantitative platelet disorders.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Number of thromboembolic events |
From baseline (day 0) to end of study (day 30) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number of serious adverse events |
From baseline (day 0) to end of study (day 30) |
| Number of allergic reactions |
From baseline (day 0) to end of study (day 30) |
| All medication errors |
At the time of administration |
| Near medication errors |
At the time of administration |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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 4 |
|
Date of First Enrollment (India)
|
26/08/2025 |
| 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="1"
Months="7"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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 an interventional, single arm, open label, Phase 4 study that will be conducted across multiple centres in India. In this study, the safety of eptacog alfa will be assessed in women with severe postpartum haemorrhage (PPH) in India in whom uterotonics were insufficient to attain haemostasis. Approximately 64 participants with severe PPH in India in whom uterotonics are insufficient to attain haemostasis will be enrolled in this study. All enrolled patients will receive one dose of eptacog alfa (60-90 µg/kg) and one additional dose of eptacog alfa (60-90 µg/kg) if required The total study duration is estimated to be 19 months. The study consists of an 18-month recruitment period, a 30-day follow-up period (This includes both 7-day follow-up visit and End of study visit – also referred to as 30day follow-up visit).
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