Safety and Pharmacology of Stanate

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

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.

Study Overview

• Status: Completed
• Conditions: Hyperbilirubinemia
• Intervention / Treatment: Drug: Stanate

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 Type: Interventional
• Enrollment (Actual): 55
• Phase: Phase 2

Contacts and Locations

Study Locations

• Vietnam
  • Hanoi, Vietnam
    • National Hospital of Pediatrics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 days to 1 week (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; stannsoporfin 0.75mg/kg	Drug: Stanate; Intramuscular injection of stannsoporfin at 0.75 or 1.5mg/kg for treatment of severe hyperbilirubinemia to prevent exchange transfusion
Experimental: 2; stannsoporfin 1.5mg/kg	Drug: Stanate; Intramuscular injection of stannsoporfin at 0.75 or 1.5mg/kg for treatment of severe hyperbilirubinemia to prevent exchange transfusion
Placebo Comparator: 3; saline injection	Drug: Stanate; Intramuscular injection of stannsoporfin at 0.75 or 1.5mg/kg for treatment of severe hyperbilirubinemia to prevent exchange transfusion

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
• Collaborators: National Children's Hospital, Vietnam

Study record dates

Study Major Dates

• Study Start: September 1, 2005
• Primary Completion (Actual): July 1, 2006
• Study Completion (Actual): July 1, 2006

Study Registration Dates

• First Submitted: June 22, 2005
• First Submitted That Met QC Criteria: June 22, 2005
• First Posted (Estimate): June 23, 2005

Study Record Updates

• Last Update Posted (Actual): October 15, 2019
• Last Update Submitted That Met QC Criteria: October 11, 2019
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: neonatal; jaundice; hyperbilirubinemia
• Additional Relevant MeSH Terms: Pathologic Processes; Hyperbilirubinemia; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Tin mesoporphyrin
• Other Study ID Numbers: 64,185-06-2W; no grant or contracts