Efficacy and Safety of Stannsoporfin in Neonates

NCT02685137 | Completed Phase 3 DMC

• 1 other identifier: 64,185-01-3W
• Study Type: interventional
• Target: 185
• Locations: 1 country
• Sites: 1

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".

Conditions

Nutritional and Metabolic Diseases

Keywords

Kernicterus; Neonatal Jaundice; Newborn Jaundice; Hyperbilirubinemia; Stannsoporfin

Outcome Measures

Primary Outcomes (1)

• Need for Phototherapy

  proportion of cases which need phototherapy in the treated population

  30 days

Secondary Outcomes (1)

• hyperbilirubinemia

  12 hrs

Study Arms (2)

Active drug-Stannsoporfin

EXPERIMENTAL

Stannsoporfin, single dose 4.5mg/kg administered Intramuscular (parental injection in the thigh) for treatment of jaundice 20 mg/mL 1.5 mL/vial

Drug: stannsoporfin

Reference Therapy-Sham

SHAM COMPARATOR

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

Other: Sham Injection

Interventions

stannsoporfin DRUG

Intramuscular injection of stannsoporfin to treat jaundice.

Active drug-Stannsoporfin

Sham Injection OTHER

nothing

Reference Therapy-Sham

Eligibility Criteria

• Age: 12 Hours - 36 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may not qualify if:

• Any condition that in the opinion of the investigator would make the subject unsuitable for the study.
• Infants receiving antibiotics who are also symptomatic are excluded. For example, a baby who is feeding poorly or is in cardiorespiratory distress is excluded.
• Mother has received phenobarbital in past 30 days.

Sponsors & Collaborators

• InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company: lead

Study Sites (1)

Pennsylvania Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Nutritional and Metabolic Diseases; Kernicterus; Jaundice, Neonatal; Hyperbilirubinemia

Interventions

tin mesoporphyrin; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Erythroblastosis, Fetal; Hematologic Diseases; Hemic and Lymphatic Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hyperbilirubinemia, Neonatal

Study Officials

• Global Clinical Leader

  Mallinckrodt

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2016
• First Posted: February 18, 2016
• Study Start: May 1, 2002
• Primary Completion: March 16, 2003
• Study Completion: February 1, 2013
• Last Updated: October 29, 2019

Record last verified: 2018-06

Locations

US (1)