NCT02156063

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

19 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

June 3, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 5, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

July 15, 2015

Status Verified

July 1, 2015

Enrollment Period

1.6 years

First QC Date

June 3, 2014

Last Update Submit

July 13, 2015

Conditions

Recurrent Pregnancy LossRecurrent Miscarriage

Keywords

Recurrent Pregnancy LossRecurrent MiscarriageMiscarriagePregnancy LossRepeated Pregnancy Loss

Outcome Measures

Primary Outcomes (1)

  • Clinical Pregnancy

    The primary outcome measure is clinical pregnancy at Week 20 of gestation

    at Week 20 of gestation

Secondary Outcomes (6)

  • Live birth

    at any time during pregnancy

  • Clinical pregnancy

    at Weeks 6, 8 and 12 of gestation

  • Spontaneous pregnancy loss

    within 24 weeks of gestation

  • Stillbirth

    after 24 weeks of gestation

  • Subjects with adverse events and serious adverse events

    during treatment and within 4 weeks after treatment

  • +1 more secondary outcomes

Study Arms (2)

NT100

EXPERIMENTAL

NT100 Dose 1

Drug: NT100

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

NT100DRUG
NT100
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 37 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Unknown Facility

Ashington, United Kingdom

Location

Unknown Facility

Birmingham, United Kingdom

Location

Unknown Facility

Chertsey, Surrey, United Kingdom

Location

Unknown Facility

Coventry, United Kingdom

Location

Unknown Facility

Edinburgh, United Kingdom

Location

Unknown Facility

Frimley, Surrey, United Kingdom

Location

Unknown Facility

Leeds, United Kingdom

Location

Unknown Facility

Liverpool, United Kingdom

Location

Unknown Facility

London, United Kingdom

Location

Unknown Facility

Manchester, United Kingdom

Location

Unknown Facility

Middlesbrough, United Kingdom

Location

Unknown Facility

Newcastle upon Tyne, United Kingdom

Location

Unknown Facility

Nottingham, United Kingdom

Location

Unknown Facility

Oxford, United Kingdom

Location

Unknown Facility

Plymouth, United Kingdom

Location

Unknown Facility

South Shields, United Kingdom

Location

Unknown Facility

Southamptom, United Kingdom

Location

Unknown Facility

Stoke-on-Trent, United Kingdom

Location

Unknown Facility

Sunderland, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 30776296DERIVED

MeSH Terms

Conditions

Abortion, HabitualAbortion, Spontaneous

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2014

First Posted

June 5, 2014

Study Start

June 1, 2014

Primary Completion

January 1, 2016

Study Completion

June 1, 2016

Last Updated

July 15, 2015

Record last verified: 2015-07

Locations

GB(19)