Safety and Pharmacology of Stanate

InfaCare Pharmaceuticals Corporation

Status and phase: Completed; Phase 2

Conditions: Hyperbilirubinemia

Treatments: Drug: Stanate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00115544

no grant or contracts

64,185-06-2W

Details and patient eligibility

About

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.

Full 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.

Enrollment: 55 patients

Sex: All

Ages: 2 to 7 days old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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55 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

stannsoporfin 0.75mg/kg

Treatment:

Drug: Stanate

2

Experimental group

Description:

stannsoporfin 1.5mg/kg

Treatment:

Drug: Stanate

3

Placebo Comparator group

Description:

saline injection

Treatment:

Drug: Stanate