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

I

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)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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