Long-Term Clinical Follow-Up of Children Enrolled in Stannsoporfin Clinical Trial Protocol No. 64,185-06-2(W)

Hyperbilirubinemia Clinical Trial

Official title:

Long-Term Clinical Follow-Up of Children Enrolled in Stannsoporfin Clinical Trial Protocol No. 64,185-06-2(W)(WS)(ISNHP)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02685189
• Other study ID #: 64,185-06LT-2
• Status: Terminated
• Start date: July 2006
• Est. completion date: May 10, 2016

Study information

• Verified date: February 2016
• Source: Mallinckrodt
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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".

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 55
• Est. completion date: May 10, 2016
• Est. primary completion date: May 10, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 60 Days

Eligibility

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:

-

Related Conditions & MeSH terms

• Hyperbilirubinemia

Intervention

Other:
• Previous exposure to stannsoporfin
No intervention in this protocol

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NEUROLOGICAL EXAMINATION; Child Behavior Check List	Child Behavior Check List is a standardized measure in child psychology for evaluating maladaptive behavioral and emotional problems in preschool patients	10 years