A Study to Evaluate Infants With Potential Exposure to Tanezumab Before Birth

Pfizer

Status: Completed

Conditions: Infant Developmental Assessment

Treatments: Other: Unintentional exposure in utero

Study type: Observational

Funder types: Industry

Identifiers

NCT01362660

A4091055

NEONATAL MONITORING

Details and patient eligibility

About

This study will examine post-natal neurologic and cognitive development of infants who may have been exposed to tanezumab or comparator in-utero during the tanezumab clinical program (whether the exposure is through maternal or paternal participation in a tanezumab clinical study).

Full description

This study will enroll infants with potential tanezumab exposure in utero at sites overseen by Schulman and Associates IRB This study will attempt to enroll all infants who qualify.

Enrollment: 7 patients

Sex: All

Ages: Under 15 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

Subject is an infant born to a mother who was exposed to study drug on a tanezumab clinical study through direct maternal exposure; or is an infant born to a mother who is a partner of a male patient who was exposed to study drug in a tanezumab clinical study prior to or around the time of conception and/or is exposed during his partner's pregnancy.

Exclusion criteria

There are no exclusion criteria for this study

Trial design

7 participants in 1 patient group

Infants with potential exposure in utero

Treatment:

Other: Unintentional exposure in utero