NCT01978561

Brief Summary

The purpose of this study is to evaluate pregnancy, delivery, and neonatal outcomes in subjects who maintain ongoing clinical pregnancies through Week 10 of gestation in NT-03.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2013

Status
completed

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

October 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 1, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 7, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

September 14, 2015

Status Verified

September 1, 2015

Enrollment Period

1.8 years

First QC Date

November 1, 2013

Last Update Submit

September 10, 2015

Conditions

Repeated IVF Failure

Outcome Measures

Primary Outcomes (1)

  • Number of live births

    Within approximately 7 months after NT-03

Secondary Outcomes (4)

  • Number of stillbirths

    Within approximately 7 months after study NT-03

  • Number of spontaneous abortions (miscarriages)

    Within approximately 7 months after study NT-03

  • Number of congenital anomalies

    Up to 4 weeks after birth

  • Number of severe neonatal adverse events

    Up to 4 weeks after birth

Study Arms (3)

Follow-Up after dosing with NT100 Dose 1

EXPERIMENTAL

Follow-Up after dosing with NT100 Dose 1

Biological: Post dosing with NT100

Follow-Up after dosing with NT100 Dose 2

EXPERIMENTAL

Follow-Up after dosing with NT100 Dose 2

Biological: Post dosing with NT100

Follow-Up after dosing with Placebo

PLACEBO COMPARATOR

Follow-Up after dosing with Placebo

Other: Post dosing with Placebo

Interventions

Post dosing with NT100BIOLOGICAL
Follow-Up after dosing with NT100 Dose 1Follow-Up after dosing with NT100 Dose 2
Post dosing with PlaceboOTHER
Follow-Up after dosing with Placebo

Eligibility Criteria

Age21 Years - 39 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • At least one dose of study drug administered in NT-03
  • Ongoing clinical pregnancy at Week 10 of gestation
  • Able and willing to enroll in NT-04

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

Study Design

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

Study Record Dates

First Submitted

November 1, 2013

First Posted

November 7, 2013

Study Start

October 1, 2013

Primary Completion

August 1, 2015

Study Completion

September 1, 2015

Last Updated

September 14, 2015

Record last verified: 2015-09