Observational Follow-up of Participants From Clinical Trial 64,185-202 (NCT00850993)

InfaCare Pharmaceuticals Corporation

Status: Completed

Conditions: Neonatal Hyperbilirubinemia; Jaundice

Treatments: Other: Phototherapy (as needed); Drug: Stannsoporfin; Drug: Placebo Control

Study type: Observational

Funder types: Industry

Identifiers

NCT02033096

64,185-203

Details and patient eligibility

About

Observational follow-up of participants from earlier interventional trial 64,185-202 (NCT00850993).

No interventions were administered during this follow-up study.

Enrollment: 42 patients

Sex: All

Ages: 30 days to 4 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Participants who received treatment in clinical trial 64,185-202 and for whom informed consent was given for long term safety followup

Exclusion criteria

Participants were excluded by the investigator for medical reasons or by parents/guardians withdrawing consent

Trial design

42 participants in 4 patient groups

Cohort 1: Stannsoporfin 1.5 mg/kg

Description:

Cohort 1: Received one 1.5 mg/kg stannsoporfin injection (with phototherapy as needed) during participation in an earlier interventional trial (NCT00850993)

Treatment:

Drug: Stannsoporfin

Other: Phototherapy (as needed)

Cohort 2: Stannsoporfin 3.0 mg/kg

Description:

Cohort 2: Received one 3.0 mg/kg stannsoporfin injection (with phototherapy as needed) during participation in an earlier interventional trial (NCT00850993)

Treatment:

Drug: Stannsoporfin

Other: Phototherapy (as needed)

Cohort 3: Stannsoporfin 4.5 mg/kg

Description:

Cohort 3: Received one 4.5 mg/kg stannsoporfin injection (with phototherapy as needed) during participation in an earlier interventional trial (NCT00850993)

Treatment:

Drug: Stannsoporfin

Other: Phototherapy (as needed)

Cohort 4: Placebo Control

Description:

Cohort 4: Received one sterile saline injection (with phototherapy as needed) during participation in an earlier interventional trial (NCT00850993)

Treatment:

Drug: Placebo Control

Other: Phototherapy (as needed)