Follow up Study of Patients Having Participated in Clinical Trial 64,185-204 (JASMINE_205)

InfaCare Pharmaceuticals Corporation

Status: Completed

Conditions: Hyperbilirubinemia, Neonatal

Treatments: Drug: Stannsoporfin; Drug: Placebo

Study type: Observational

Funder types: Industry

Identifiers

NCT02000830

64,185-205

Details and patient eligibility

About

The objectives of this follow up study are to evaluate the long-term effects of stannsoporfin (Stanate) on the health, growth, and development of patients who received a single dose of stannsoporfin with PT used to treat hyperbilirubinemia compared with patients in the control (placebo plus PT) group in clinical trial 64,185-204.

Full description

Outcomes will be based on the following variables:

Reported AEs and SAEs Hearing assessments Developmental assessments

Enrollment: 68 patients

Sex: All

Ages: 30 days to 52 months old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Patients who received IMP (stannsoporfin or placebo) in clinical trial 64,185-204
• Parents or guardians have given written informed consent to participate

Trial design

68 participants in 3 patient groups

Placebo

Description:

Participants received placebo during the earlier study

Treatment:

Drug: Placebo

Stannsoporfin 3.0 mg/kg

Description:

Participants received Stannsoporfin 3.0 mg/kg during the earlier study

Treatment:

Drug: Stannsoporfin

Stannsoporfin 4.5 mg/kg

Description:

Participants received Stannsoporfin 4.5 mg/kg during the earlier study

Treatment:

Drug: Stannsoporfin