A Multi-center, Placebo-controlled Study to Evaluate NT100 in Pregnant Women With a History of Unexplained Recurrent Pregnancy Loss (RPL)
NCT ID: NCT02156063
Last Updated: 2015-07-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
150 participants
INTERVENTIONAL
2014-06-30
2016-06-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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NT100
NT100 Dose 1
NT100
Placebo
Placebo
Placebo
Interventions
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NT100
Placebo
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
37 Years
FEMALE
No
Sponsors
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Nora Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Ashington, , United Kingdom
Birmingham, , United Kingdom
Chertsey, Surrey, , United Kingdom
Coventry, , United Kingdom
Edinburgh, , United Kingdom
Frimley, Surrey, , United Kingdom
Leeds, , United Kingdom
Liverpool, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Middlesbrough, , United Kingdom
Newcastle upon Tyne, , United Kingdom
Nottingham, , United Kingdom
Oxford, , United Kingdom
Plymouth, , United Kingdom
South Shields, , United Kingdom
Southamptom, , United Kingdom
Stoke-on-Trent, , United Kingdom
Sunderland, , United Kingdom
Countries
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References
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Eapen A, Joing M, Kwon P, Tong J, Maneta E, De Santo C, Mussai F, Lissauer D, Carter D; RESPONSE study group. Recombinant human granulocyte- colony stimulating factor in women with unexplained recurrent pregnancy losses: a randomized clinical trial. Hum Reprod. 2019 Mar 1;34(3):424-432. doi: 10.1093/humrep/dey393.
Other Identifiers
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NT-05
Identifier Type: -
Identifier Source: org_study_id
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