Back to resultsA Multi-center, Placebo-controlled Study to Evaluate NT100 in Pregnant Women With a History of Unexplained Recurrent Pregnancy Loss (RPL) (RESPONSE)
Primary Purpose
Recurrent Pregnancy Loss, Recurrent Miscarriage
Status
Unknown status
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
NT100
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent Pregnancy Loss focused on measuring Recurrent Pregnancy Loss, Recurrent Miscarriage, Miscarriage, Pregnancy Loss, Repeated Pregnancy Loss
Eligibility Criteria
Inclusion Criteria:
- Pre-menopausal female 18-37 years of age at consent, trying to conceive
- Documented history of unexplained recurrent pregnancy loss
- Spontaneous conception, as confirmed by urine pregnancy test performed at the investigative site
- Body mass index (BMI) of 19-35 kg/m2 at consent
Exclusion Criteria:
- Greater than 5 weeks of gestation when presenting for randomisation.
- Known karyotype abnormalities in either the participant or her current male partner
- Uncorrected clinically significant intrauterine abnormalities
- Abnormal vaginal bleeding of unknown cause
- Current diagnosis of infertility in either the participant or her current male partner
- Current or past diagnosis of systemic autoimmune disease, coagulopathy, hyperprolactinemia, cervical incompetence, or high-grade cervical dysplasia with conization/surgery.
- Any uncontrolled clinically significant medical condition
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
NT100
Placebo
Arm Description
NT100 Dose 1
Placebo
Outcomes
Primary Outcome Measures
Clinical Pregnancy
The primary outcome measure is clinical pregnancy at Week 20 of gestation
Secondary Outcome Measures
Live birth
Clinical pregnancy
Spontaneous pregnancy loss
Stillbirth
Subjects with adverse events and serious adverse events
Changes in clinical laboratory parameters following study drug exposure
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02156063
Brief Title
A Multi-center, Placebo-controlled Study to Evaluate NT100 in Pregnant Women With a History of Unexplained Recurrent Pregnancy Loss (RPL)
Acronym
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)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
June 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nora Therapeutics, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Pregnancy Loss, Recurrent Miscarriage
Keywords
Recurrent Pregnancy Loss, Recurrent Miscarriage, Miscarriage, Pregnancy Loss, Repeated Pregnancy Loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NT100
Arm Type
Experimental
Arm Description
NT100 Dose 1
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
NT100
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Clinical Pregnancy
Description
The primary outcome measure is clinical pregnancy at Week 20 of gestation
Time Frame
at Week 20 of gestation
Secondary Outcome Measure Information:
Title
Live birth
Time Frame
at any time during pregnancy
Title
Clinical pregnancy
Time Frame
at Weeks 6, 8 and 12 of gestation
Title
Spontaneous pregnancy loss
Time Frame
within 24 weeks of gestation
Title
Stillbirth
Time Frame
after 24 weeks of gestation
Title
Subjects with adverse events and serious adverse events
Time Frame
during treatment and within 4 weeks after treatment
Title
Changes in clinical laboratory parameters following study drug exposure
Time Frame
during treatment and within 4 weeks after treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
37 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pre-menopausal female 18-37 years of age at consent, trying to conceive
Documented history of unexplained recurrent pregnancy loss
Spontaneous conception, as confirmed by urine pregnancy test performed at the investigative site
Body mass index (BMI) of 19-35 kg/m2 at consent
Exclusion Criteria:
Greater than 5 weeks of gestation when presenting for randomisation.
Known karyotype abnormalities in either the participant or her current male partner
Uncorrected clinically significant intrauterine abnormalities
Abnormal vaginal bleeding of unknown cause
Current diagnosis of infertility in either the participant or her current male partner
Current or past diagnosis of systemic autoimmune disease, coagulopathy, hyperprolactinemia, cervical incompetence, or high-grade cervical dysplasia with conization/surgery.
Any uncontrolled clinically significant medical condition
Facility Information:
City
Ashington
Country
United Kingdom
City
Birmingham
Country
United Kingdom
City
Chertsey, Surrey
Country
United Kingdom
City
Coventry
Country
United Kingdom
City
Edinburgh
Country
United Kingdom
City
Frimley, Surrey
Country
United Kingdom
City
Leeds
Country
United Kingdom
City
Liverpool
Country
United Kingdom
City
London
Country
United Kingdom
City
Manchester
Country
United Kingdom
City
Middlesbrough
Country
United Kingdom
City
Newcastle upon Tyne
Country
United Kingdom
City
Nottingham
Country
United Kingdom
City
Oxford
Country
United Kingdom
City
Plymouth
Country
United Kingdom
City
South Shields
Country
United Kingdom
City
Southamptom
Country
United Kingdom
City
Stoke-on-Trent
Country
United Kingdom
City
Sunderland
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
30776296
Citation
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.
Results Reference
derived
Learn more about this trial
A Multi-center, Placebo-controlled Study to Evaluate NT100 in Pregnant Women With a History of Unexplained Recurrent Pregnancy Loss (RPL)
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