A Research Study to See How Safe is Eptacog Alfa When Used to Stop Heavy Bleeding in Women After Giving Birth in India

StatusRecruiting
PhasePhase 4
Started

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Trial flagged as At Risk
Primary completion moved at least 5 months later Mar 26, 2027 → Aug 26, 2027
See other at-risk trials from Novo Nordisk

Record History

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  1. Lead sponsor: Novo Nordisk A/S to Novo Nordisk A/S
    • Eligibility criteria expanded, about 10 words
    • Site details revised at 6 of 14 sites
  2. Primary and study completion pushed from Mar 26, 2027 to Aug 26, 2027
    • Trial sites expanded: 10 → 14 locations
    v4
  3. Study sites: 8 to 10v3
  4. Site details revised at 2 of 8 sitesv2
  5. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Novo Nordisk
269 trials monitored
See 14 trials at risk
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.
Trial Details
NCT Number NCT07157423
Lead Sponsor Novo Nordisk A/S
Conditions
(from sponsor)		 Severe Postpartum Haemorrhage
Related terms Postpartum Hemorrhage
Enrollment 64 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov