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

Recurrent Pregnancy Loss Clinical Trial

— RESPONSE  

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02156063
• Other study ID #: NT-05
• Status: Active, not recruiting
• Phase: Phase 2
• First received: June 3, 2014
• Last updated: July 13, 2015
• Start date: June 2014
• Est. completion date: June 2016

Study information

• Verified date: July 2015
• Source: Nora Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: June 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 37 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abortion, Habitual
• Abortion, Spontaneous
• Fetal Death
• Recurrent Miscarriage
• Recurrent Pregnancy Loss

Intervention

Drug:
• NT100

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nora Therapeutics, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Pregnancy	The primary outcome measure is clinical pregnancy at Week 20 of gestation	at Week 20 of gestation	No
Secondary	Live birth		at any time during pregnancy	No
Secondary	Clinical pregnancy		at Weeks 6, 8 and 12 of gestation	No
Secondary	Spontaneous pregnancy loss		within 24 weeks of gestation	No
Secondary	Stillbirth		after 24 weeks of gestation	No
Secondary	Subjects with adverse events and serious adverse events		during treatment and within 4 weeks after treatment	No
Secondary	Changes in clinical laboratory parameters following study drug exposure		during treatment and within 4 weeks after treatment	No

External Links

•   Response Study website