Overview

This trial is active, not recruiting.

Condition hyperbilirubinemia
Treatment previous exposure to stannsoporfin
Sponsor InfaCare Pharmaceuticals Corporation
Start date July 2006
End date December 2016
Trial size 55 participants
Trial identifier NCT02685189, 64,185-06LT-2

Summary

The purpose of this protocol is to provide a mechanism to collect Long Term Clinical Data from those babies who participated in the primary Study 64,185-06-2(W)(WS)(ISNHP) "An Open-Label Study Of The Safety And Clinical Pharmacology Of Stanate® In Infants At-Risk For Exchange Transfusion".

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Previous exposure 0.75 mg/kg
previous exposure to stannsoporfin
No intervention in this protocol
Previous exposure 1.5 mg/kg
previous exposure to stannsoporfin
No intervention in this protocol

Primary Outcomes

Measure
NEUROLOGICAL EXAMINATION; Child Behavior Check List
time frame: 10 years

Eligibility Criteria

Male or female participants up to 60 days old.

Inclusion Criteria: - All children who have been enrolled and received Stanate® Injection/Placebo in Study Protocol 64,185-06-2(W)(WS)(ISNHP) are eligible for this follow-up. Exclusion Criteria:

Additional Information

Official title LONG-TERM CLINICAL FOLLOW-UP OF CHILDREN ENROLLED IN STANNSOPORFIN CLINICAL TRIAL PROTOCOL NO. 64,185-06-2(W)(
Description The purpose of this protocol is to provide a mechanism to collect Clinical Data from those babies who participated in the primary Study 64,185-06-2(W)(WS)(ISNHP) "An Open-Label Study Of The Safety And Clinical Pharmacology Of Stanate® In Infants At-Risk For Exchange Transfusion". Data on long-term impact of Stannsoporfin on the physical, neurological, neurodevelopmental, biochemical, metabolic and hematopoietic profiles of the children will be collected at 9 and 18 months, 3, 6 and 9 years after Stannsoporfin administration
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by InfaCare Pharmaceuticals Corporation.