Safety and Pharmacology of Stanate

Hyperbilirubinemia Clinical Trial

Official title:

An Open-Label Study of the Safety and Clinical Pharmacology of Stanate® in Infants At-Risk for Exchange Transfusion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00115544
• Other study ID #: 64,185-06-2W
• Secondary ID: no grant or cont
• Status: Completed
• Phase: Phase 2
• Start date: September 2005
• Est. completion date: July 2006

Study information

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

Clinical Trial Summary

The purpose of this study is to evaluate the effect and safety of Stanate (stannsoporfin) in infants who are at risk for an exchange transfusion and meet the criteria of the protocol.

Description:

The present study evaluated the relationship between Stanate® dose, drug safety, and efficacy in a non randomised sequential open label cohort design, in 55 patients. Subjects were term and near term infants at medium or high risk of hyperbilirubinemia with TSB levels approaching the threshold for exchange transfusion. The first cohort began at a dose of stannsoporfin 0.75 mg/kg of birth weight intramuscularly. The dose was then increased to 1.5 mg/kg for cohort 2, and saline was given (placebo) for cohort 3. Safety evaluations consisted of hepatic, renal and hematologic clinical laboratory tests along with serial physical examinations. Long term follow up of all patients to age 6 is planned.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: July 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 7 Days

Eligibility

Inclusion Criteria:

• Term and near-term healthy infants (may be no more than 14 days of age) with excessive hyperbilirubinemia who are at risk for exchange transfusion according to the AAP guidelines of 2004

Exclusion Criteria:

• No parental consent

• Major known congenital anomaly

• Current use of antibiotics, cardio-respiratory instability, abnormal renal function, hepatitis (as related to TORCH infections)

• Phenobarbital use in either child or mother (30 days prior to child's birth)

Related Conditions & MeSH terms

• Hyperbilirubinemia

Intervention

Drug:
• Stanate
Intramuscular injection of stannsoporfin at 0.75 or 1.5mg/kg for treatment of severe hyperbilirubinemia to prevent exchange transfusion

Locations

Country	Name	City	State
Vietnam	National hospital of pediatrics	Hanoi

Sponsors (2)

Lead Sponsor	Collaborator
InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company	National Children's Hospital, Vietnam

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of serum bilirubin levels; need for exchange transfusion, safety parameters		30 days with long term f/u