Overview

This trial is active, not recruiting.

Conditions recurrent pregnancy loss, recurrent miscarriage
Treatments nt100, placebo
Phase phase 2
Sponsor Nora Therapeutics, Inc.
Start date June 2014
End date January 2016
Trial size 150 participants
Trial identifier NCT02156063, NT-05

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
NT100 Dose 1
nt100
(Placebo Comparator)
Placebo
placebo

Primary Outcomes

Measure
Clinical Pregnancy
time frame: at Week 20 of gestation

Secondary Outcomes

Measure
Live birth
time frame: at any time during pregnancy
Clinical pregnancy
time frame: at Weeks 6, 8 and 12 of gestation
Spontaneous pregnancy loss
time frame: within 24 weeks of gestation
Stillbirth
time frame: after 24 weeks of gestation
Subjects with adverse events and serious adverse events
time frame: during treatment and within 4 weeks after treatment
Changes in clinical laboratory parameters following study drug exposure
time frame: during treatment and within 4 weeks after treatment

Eligibility Criteria

Female participants from 18 years up to 37 years old.

Inclusion Criteria: 1. Pre-menopausal female 18-37 years of age at consent, trying to conceive 2. Documented history of unexplained recurrent pregnancy loss 3. Spontaneous conception, as confirmed by urine pregnancy test performed at the investigative site 4. Body mass index (BMI) of 19-35 kg/m2 at consent Exclusion Criteria: 1. Greater than 5 weeks of gestation when presenting for randomisation. 2. Known karyotype abnormalities in either the participant or her current male partner 3. Uncorrected clinically significant intrauterine abnormalities 4. Abnormal vaginal bleeding of unknown cause 5. Current diagnosis of infertility in either the participant or her current male partner 6. Current or past diagnosis of systemic autoimmune disease, coagulopathy, hyperprolactinemia, cervical incompetence, or high-grade cervical dysplasia with conization/surgery. 7. Any uncontrolled clinically significant medical condition

Additional Information

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)
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Nora Therapeutics, Inc..