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

• Status: Completed
• Trial end date: 2020-02-28
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: InfaCare Pharmaceuticals Corporation; InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
• Treatments: Tin mesoporphyrin

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