Safety and Pharmacology of Stanate

Phase 2

Completed

• Conditions: Hyperbilirubinemia
• Interventions: Drug: Stanate

• Registration Number: NCT00115544
• Lead Sponsor: InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2005-06-22
• Study First Submitted QC: 2005-06-22
• Study First Posted: 2005-06-23
• Study Start: 2005-09
• Primary Completion: 2006-07
• Study Completion: 2006-07
• Status Verified: 2016-02
• Last Update Submitted: 2019-10-11
• Last Update Posted: 2019-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Stanate	stannsoporfin 0.75mg/kg
2	Stanate	stannsoporfin 1.5mg/kg
3	Stanate	saline injection

Primary Outcome Measures

Name	Time	Method
Reduction of serum bilirubin levels; need for exchange transfusion, safety parameters	30 days with long term f/u

Trial Locations

Locations (1)

National hospital of pediatrics; 🇻🇳 Hanoi, Vietnam