A Four-Year Blinded Outcomes Follow-up Study of Patients Who Received Stannsoporfin or Placebo in Clinical Trial 64,185-204
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 68
- Primary Endpoint
- Reported adverse events (AEs)
Study Overview
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
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 30 Days to 52 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Exclusion Criteria
- Not provided
Arms & Interventions
Placebo
Participants received placebo during the earlier study
Intervention: Placebo (Drug)
Stannsoporfin 3.0 mg/kg
Participants received Stannsoporfin 3.0 mg/kg during the earlier study
Intervention: Stannsoporfin (Drug)
Stannsoporfin 4.5 mg/kg
Participants received Stannsoporfin 4.5 mg/kg during the earlier study
Intervention: Stannsoporfin (Drug)
Outcomes
Primary Outcomes
Reported adverse events (AEs)
Time Frame: 48-52 month
Secondary Outcomes
- Developmental assessments(48 - 52 month)
- Hearing assessments(48 - 52 month)