Severe Postpartum HaemorrhagePhase 4NCT07157423
A Research Study to See How Safe is Eptacog Alfa When Used to Stop Heavy Bleeding in Women After Giving Birth in India
A Phase 4 study testing Eptacog alfa (NovoSeven) in people with Severe Postpartum Haemorrhage, run by Novo Nordisk A/S at 14 sites in India.
Trial summary
This study will look at how safe is the medicine eptacog alfa when used in women in India for stopping heavy bleeding after giving birth. If participants have heavy bleeding after giving birth then they will get the medicine eptacog alfa. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Severe Postpartum Haemorrhage
- What is being tested?
- Eptacog alfa (NovoSeven)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 14 sitesIndia
- Study dates
- 26 Aug 2025to 26 Aug 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent 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
- Adult women aged greater than or equal to (≥) 18 years at the time of signing the informed consent and who deliver after 27 weeks diagnosed with severe postpartum haemorrhage (PPH) who fail to respond to uterotonics
Who cannot join
- Previous participation in this study. Participation is defined as having given informed consent in this study
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
- Patient with a history of thromboembolism
- Patient with a history of bleeding disorders
- 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
- Have undergone invasive obstetric procedures for the ongoing haemorrhage prior to trial enrolment (uterine balloon tamponade and external aortic compression not included)
- Any chronic disorder or severe disease which, in the opinion of the Investigator, might jeopardise patient's safety or compliance with the protocol
- Participation (i.e., signed informed consent) in any other interventional clinical study prior to screening in the current study
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
India14 sites, 13 recruiting
- Recruiting
SN Medical College
Agra, Uttar Pradesh, 282003
- Recruiting
KLE Belgum
Belagavi, Karnataka, 590010
- Not yet recruiting
KLE Belgum
Belagavi, 590010
- Recruiting
Post Graduate Institute of Medical Education & Research_Chandigarh
Chandigarh, 160012
- Not yet recruiting
Post Graduate Institute of Medical Education & Research_Chandigarh
Chandigarh, 160012
- Recruiting
Modern Government Maternity Hospital
Hyderabad, Telangana, 500064
- Completed
SMS Hospital
Jaipur, Rajasthan, 302004
- Not yet recruiting
SMS Hospital
Jaipur, Rajasthan, 302004
- Recruiting
Calicut Medical College
Kozhikode, Kerala, 673008
- Not yet recruiting
Calicut Medical College
Kozhikode, Kerala, 673008
- Recruiting
Seth GS Medical College & KEM Hospital
Mumbai, Maharashtra, 400012
- Recruiting
Mysore Medical College and Research Institute
Mysore, Karnataka, 570001
- Recruiting
All India Institute of Medical Sciences_New Dehli
New Delhi, National Capital Territory of Delhi, 110029
- Not yet recruiting
RNT Medical College
Udaipur, Rajasthan, 313001
About this study
Official title: Safety of Eptacog Alfa in Severe Postpartum Haemorrhage in India: A Phase IV Interventional Study
This study will look at how safe is the medicine eptacog alfa when used in women in India for stopping heavy bleeding after giving birth. If participants have heavy bleeding after giving birth then they will get the medicine eptacog alfa. This study will be conducted to get more knowledge on the safety of the medicine eptacog alfa use in these women. At first participants will receive one dose of medicine eptacog alfa. If the given dose is not helpful to stop the bleeding, participants will get one additional dose. The study will last for about 30-35 days.
- Conditions
- Severe Postpartum Haemorrhage
- Being tested
- Eptacog alfa (NovoSeven)
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eptacog alfa (NovoSeven)Drug
Participants will receive single dose of intravenous bolus injection of eptacog alfa (NovoSeven)
| Study group | Role | What they receive |
|---|---|---|
| Eptacog alfa (NovoSeven) | Experimental | Participants will receive single dose of intravenous bolus injection of eptacog alfa (NovoSeven) Receives: Drug: Eptacog alfa (NovoSeven) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of thromboembolic events
Measured as number of events
Measured: From baseline (day 0) to end of study (day 30)
Secondary outcomes (4)
Number of serious adverse events
Measured as number of events
Measured: From baseline (day 0) to end of study (day 30)
Number of allergic reactions
Measured as number of allergic reactions
Measured: From baseline (day 0) to end of study (day 30)
All medication errors
Measured as number of all medication errors
Measured: Baseline (day 0)
Near medication errors
Measured as number of near medication errors
Measured: Baseline (day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start26 Aug 2025
- Primary completion26 Aug 2027 (estimated)
- Study completion26 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Postpartum HaemorrhageStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07157423
- Sponsor's protocol ID
- NN7711-7717
- Other IDs
- U1111-1289-2568
- Status last verified
- Sep 2026
- First submitted
- 19 Aug 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Eptacog Alfa in Severe Postpartum Haemorrhage in India: A Phase IV Interventional Study
- ClinicalTrials.gov ID
- NCT07157423
- Acronym / sponsor ID
- NN7711-7717
- Conditions
- Severe Postpartum Haemorrhage
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 26 Aug 2025 (actual)
- Primary completion
- 26 Aug 2027 (estimated)
- Study completion
- 26 Aug 2027 (estimated)
- First posted
- 5 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will look at how safe is the medicine eptacog alfa when used in women in India for stopping heavy bleeding after giving birth. If participants have heavy bleeding after giving birth then they will get the medicine eptacog alfa. This study will be conducted to get more knowledge on the safety of the medicine eptacog alfa use in these women. At first participants will receive one dose of medicine eptacog alfa. If the given dose is not helpful to stop the bleeding, participants will get one additional dose. The study will last for about 30-35 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eptacog alfa (NovoSeven) | Experimental | Drug: Eptacog alfa (NovoSeven)Participants will receive single dose of intravenous bolus injection of eptacog alfa (NovoSeven) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Informed consent 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
- Adult women aged greater than or equal to (≥) 18 years at the time of signing the informed consent and who deliver after 27 weeks diagnosed with severe postpartum haemorrhage (PPH) who fail to respond to uterotonics
Key exclusion criteria (8 listed)
- Previous participation in this study. Participation is defined as having given informed consent in this study
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
- Patient with a history of thromboembolism
- Patient with a history of bleeding disorders
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eptacog alfa (NovoSeven)Participants will receive single dose of intravenous bolus injection of eptacog alfa (NovoSeven) | Drug | Eptacog alfa (NovoSeven) |
Primary outcome
Number of thromboembolic events
Time frame: From baseline (day 0) to end of study (day 30)
Measured as number of events
4 secondary outcomes
Number of serious adverse events
Time frame: From baseline (day 0) to end of study (day 30)
Number of allergic reactions
Time frame: From baseline (day 0) to end of study (day 30)
All medication errors
Time frame: Baseline (day 0)
Near medication errors
Time frame: Baseline (day 0)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Related trials for Severe Postpartum Haemorrhage
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinical Transparency (dept. 2834) study director
Novo Nordisk A/S
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Eptacog alfa (NovoSeven) in people with Severe Postpartum Haemorrhage, run by Novo Nordisk A/S at 14 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novo Nordisk ((+1) 866-867-7178, clinicaltrials@novonordisk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of thromboembolic events (time frame: From baseline (day 0) to end of study (day 30)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.