Follow up Study of Patients Having Participated in Clinical Trial 64,185-204
- Registration Number
- NCT02000830
- Lead Sponsor
- InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
- Brief 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.
- Detailed Description
Outcomes will be based on the following variables:
Reported AEs and SAEs Hearing assessments Developmental assessments
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 68
- Patients who received IMP (stannsoporfin or placebo) in clinical trial 64,185-204
- Parents or guardians have given written informed consent to participate
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants received placebo during the earlier study Stannsoporfin 3.0 mg/kg Stannsoporfin Participants received Stannsoporfin 3.0 mg/kg during the earlier study Stannsoporfin 4.5 mg/kg Stannsoporfin Participants received Stannsoporfin 4.5 mg/kg during the earlier study
- Primary Outcome Measures
Name Time Method Reported adverse events (AEs) 48-52 month
- Secondary Outcome Measures
Name Time Method Developmental assessments 48 - 52 month The Mullen Scales of Early Learning examination has been selected for its standardized measurement of developmental skills in multiple domains (gross motor, visual reception, fine motor, expressive language, and receptive language). Testing will be done at visits 1 and 2 by a healthcare individual trained to administer the test. The Mullen raw scores, T-scores, and age equivalents will be recorded.
Hearing assessments 48 - 52 month Conventional audiometry will be performed by a qualified specialist. Any findings from a failed conventional audiology examination will be recorded