Follow-Up Of Pregnancies Established During Study NT-03 (Thrive-IVF Follow-Up) (Thrive-IVF F/U)

Nora Therapeutics

Status and phase: Completed; Phase 2

Conditions: Repeated IVF Failure

Treatments: Biological: Post dosing with NT100; Other: Post dosing with Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01978561

NT-04

Details and patient eligibility

About

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.

Full description

NT-04 is a follow-up study that will include subjects who received at least one dose of study drug and maintain ongoing clinical pregnancies through Week 10 of gestation during NT-03. NT-04 does not involve the administration of study drug treatment.

In NT-03, subjects who achieve an ongoing clinical pregnancy at Week 8 of gestation will undergo a repeat transvaginal ultrasound (TVU) at Week 10 of gestation (4 weeks after last dose of study drug). Subjects who are pregnant at Week 10 of gestation will be enrolled in NT-04.

Subjects in NT-04 will be contacted by telephone every 6 to 8 weeks until Week 38 of gestation, at which time subjects will be contacted every two weeks until confirmation of delivery. Information about pregnancy status and use of prescription medications will be collected at these telephone interviews.

Between Weeks 18 and 22 of gestation, an obstetrical ultrasound will be performed.

Following delivery, additional information will be obtained, including pregnancy outcome, gestational age at delivery, etc. Standardized photographs will be taken as part of a newborn assessment.

Enrollment: 40 patients

Sex: Female

Ages: 21 to 39 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• None

Trial design

40 participants in 3 patient groups, including a placebo group

Follow-Up after dosing with NT100 Dose 1

Experimental group

Description:

Follow-Up after dosing with NT100 Dose 1

Treatment:

Biological: Post dosing with NT100

Follow-Up after dosing with NT100 Dose 2

Experimental group

Description:

Follow-Up after dosing with NT100 Dose 2

Treatment:

Biological: Post dosing with NT100

Follow-Up after dosing with Placebo

Placebo Comparator group

Description:

Follow-Up after dosing with Placebo

Treatment:

Other: Post dosing with Placebo