NCT02156063

A Multi-center, Placebo-controlled Study to Evaluate NT100 in Pregnant Women With a History of Unexplained Recurrent Pregnancy Loss (RPL)

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)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Nora Therapeutics, Inc. · Industry
• Sex: Female
• Age: 18 Years – 37 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Recurrent Pregnancy Loss
• Recurrent Miscarriage

Interventions

Type	Name	Description
DRUG	NT100
DRUG	Placebo

Timeline

• Start date: 2014-06-01
• Primary completion: 2016-01-01
• Completion: 2016-06-01
• First posted: 2014-06-05
• Last updated: 2015-07-15

Locations

19 sites across 1 country: United Kingdom