Efficacy and Safety of Stannsoporfin in Neonates

NCT ID: NCT02685137

Last Updated: 2019-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 185 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-05-01
• Study Completion Date: 2013-02-28

Brief Summary

This is a multi-center, randomized, sham injection-controlled (placebo) masked trial of a single intramuscular injection of Stannsoporfin compared to "sham" (placebo) in healthy term and near-term newborns admitted to the well-baby nursery and enrolled with "intention to treat".

Detailed Description

For purposes of analysis, 2 patient populations are defined. One population consists of those babies who did not develop severe hyperbilirubinemia (TSB <9 mg/dL) during the first 36 hours of age. This population is referred to as the untreated population of screened but not randomized patients. The second population of babies was defined as those infants who develop severe hyperbilirubinemia. These infants were randomized to treatment with either stannsoporfin or the sham injection and will be the focus of the efficacy and safety analysis. This population was referred to as the treated population.

The treated population was used for the efficacy and safety analysis. These infants were randomized to either stannsoporfin or the sham injection treatment group.

Conditions

Nutritional and Metabolic Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Active drug-Stannsoporfin

Stannsoporfin, single dose 4.5mg/kg administered Intramuscular (parental injection in the thigh) for treatment of jaundice

20 mg/mL 1.5 mL/vial

Group Type: EXPERIMENTAL

stannsoporfin

Intervention Type: DRUG

Intramuscular injection of stannsoporfin to treat jaundice.

Reference Therapy-Sham

Sham Injection, no injection followed by a Band-Aid to thigh

Group Type: SHAM_COMPARATOR

Sham Injection

Intervention Type: OTHER

nothing

Interventions

stannsoporfin

Intramuscular injection of stannsoporfin to treat jaundice.

Intervention Type: DRUG

Sham Injection

nothing

Intervention Type: OTHER

Eligibility Criteria

Exclusion Criteria

4. Born at the study hospital site and admitted to the well-baby nursery or admitted to the intensive-care nursery for <12 hours for post delivery observation (delayed transition, temperature or dextrose instability, meconium staining and/or parental concern).

5. All babies on oral feeding with stable cardiorespiratory status and deemed "healthy" upon clinical examination, with normal perfusion as defined by capillary filling of the fingernail.

6. Term neonate (≥38 weeks of completed gestation), OR

7. Near-term neonate (>36<38 weeks of completed gestation; >2,000g birth weight), OR

8. Near-term neonate (>35<38 weeks of completed gestation; >2,500g birth weight)

9. Care provided (primarily) in the well-baby nursery population;

10. Absence of concurrent cardiorespiratory distress, sepsis, major congenital anomalies or need for care in an intensive care nursery;

11. Not participating in another concurrent unrelated study.

1. Any condition that in the opinion of the investigator would make the subject unsuitable for the study.

2. Infants receiving antibiotics who are also symptomatic are excluded. For example, a baby who is feeding poorly or is in cardiorespiratory distress is excluded.

3. Mother has received phenobarbital in past 30 days.

• Minimum Eligible Age: 12 Hours
• Maximum Eligible Age: 36 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Global Clinical Leader

Role: STUDY_DIRECTOR

Mallinckrodt

Locations

Pennsylvania Hospital

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

64,185-01-3W

Identifier Type: -

Identifier Source: org_study_id