Recurrent Pregnancy Loss Clinical Trial
Official title:
A Randomised, Double Blind, Multi-center, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of NT100 in Pregnant Women With a History of Unexplained Recurrent Pregnancy Loss (RPL)
This is a randomised, double blind, multi-center, placebo-controlled study of subcutaneous NT100 in pregnant women with a history of unexplained recurrent pregnancy loss. Approximately 150 participants will be randomised to receive subcutaneous NT100 or placebo.
This is a randomised, double blind, multi-center, placebo-controlled study of subcutaneous
NT100 in pregnant women with a history of unexplained recurrent pregnancy loss.
Approximately 150 participants will be randomised to receive subcutaneous NT100 or placebo.
Participants will be screened for eligibility, and will begin attempts at spontaneous
conception. Following randomization and initiation of study drug treatment, participants
will visit the study site at specified intervals throughout the study for assessments and
blood work.
All participants will be monitored for adverse events. All participants who have received at
least one dose of study drug will be followed for safety for a minimum of 4 weeks following
the last dose of study drug. After delivery, pregnancy outcome information will be obtained.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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