Trials / Completed
CompletedNCT02000830
Follow up Study of Patients Having Participated in Clinical Trial 64,185-204
A Four-Year Blinded Outcomes Follow-up Study of Patients Who Received Stannsoporfin or Placebo in Clinical Trial 64,185-204
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 68 (actual)
- Sponsor
- InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company · Industry
- Sex
- All
- Age
- 30 Days – 52 Months
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Stannsoporfin | Stannsoporfin administered by intramuscular (IM) injection |
| DRUG | Placebo | Matching placebo administered by IM injection |
Timeline
- Start date
- 2013-10-17
- Primary completion
- 2020-02-28
- Completion
- 2020-02-28
- First posted
- 2013-12-04
- Last updated
- 2021-02-02
Source: ClinicalTrials.gov record NCT02000830. Inclusion in this directory is not an endorsement.