Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1289-2568 | Other Identifier | World Health Organization (WHO) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eptacog alfa (NovoSeven) | Experimental | Participants will receive single dose of intravenous bolus injection of eptacog alfa (NovoSeven) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eptacog alfa (NovoSeven) | Drug | Participants will receive single dose of intravenous bolus injection of eptacog alfa (NovoSeven) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of thromboembolic events | Measured as number of events | From baseline (day 0) to end of study (day 30) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of serious adverse events | Measured as number of events | From baseline (day 0) to end of study (day 30) |
| Number of allergic reactions | Measured as number of allergic reactions |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novo Nordisk | Contact | (+1) 866-867-7178 | clinicaltrials@novonordisk.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KLE Belgum | Recruiting | Belagavi | Karnataka | 590010 | India | |
| Calicut Medical College |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| From baseline (day 0) to end of study (day 30) |
| All medication errors | Measured as number of all medication errors | Baseline (day 0) |
| Near medication errors | Measured as number of near medication errors | Baseline (day 0) |
| Recruiting |
| Kozhikode |
| Kerala |
| 673008 |
| India |
| Calicut Medical College | Not yet recruiting | Kozhikode | Kerala | 673008 | India |
| Seth GS Medical College & KEM Hospital | Recruiting | Mumbai | Maharashtra | 400012 | India |
| All India Institute of Medical Sciences_New Dehli | Recruiting | New Delhi | National Capital Territory of Delhi | 110029 | India |
| SMS Hospital | Recruiting | Jaipur | Rajasthan | 302004 | India |
| SMS Hospital | Not yet recruiting | Jaipur | Rajasthan | 302004 | India |
| KLE Belgum | Not yet recruiting | Belagavi | 590010 | India |
| Post Graduate Institute of Medical Education & Research_Chandigarh | Recruiting | Chandigarh | 160012 | India |
| Post Graduate Institute of Medical Education & Research_Chandigarh | Not yet recruiting | Chandigarh | 160012 | India |
| ID | Term |
|---|---|
| D006473 | Postpartum Hemorrhage |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D011644 | Puerperal Disorders |
| D014592 | Uterine Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C103587 | recombinant FVIIa |
Not provided
Not provided
Not provided