Safety and Pharmacology of Stanate

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2006-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hyperbilirubinemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

stannsoporfin 0.75mg/kg

Group Type EXPERIMENTAL

Stanate

Intervention Type DRUG

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

2

stannsoporfin 1.5mg/kg

Group Type EXPERIMENTAL

Stanate

Intervention Type DRUG

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

3

saline injection

Group Type PLACEBO_COMPARATOR

Stanate

Intervention Type DRUG

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

Interventions

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Stanate

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

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

2 Days

Maximum Eligible Age

7 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No