A Phase 2b, Multicenter, Single-dose, Blinded, Randomized, Placebo-controlled, Dose-escalation, Safety and Efficacy Trial of Stannsoporfin in Neonates With Hyperbilirubinemia
| City: |
|
Royal Oak |
| State: |
|
Michigan |
| Zip Code: |
|
48073 |
| Conditions: |
|
Hyperbilirubinemia, Neonatal |
| Purpose: |
|
The purpose of this study is to determine if an experimental drug, Stanate®, is safe and
effective in the treatment of hyperbilirubinemia in hemolyzing neonates.
|
| Study Summary: |
|
|
| Criteria: |
|
Inclusion Criteria:
- Term and late preterm subjects
- Risk factors for hemolytic disease to include ABO blood type incompatibility or Rh
incompatibility (anti-C, c, D, E, or e, or G6PD deficiency
- A minimum birth weight of 2500 g (5.5 lbs)
- Enrollment within 2 mg/dL below the TSB threshold for PT per the AAP Guidelines at up
to 12 hours of age or within 3 mg/dL below the threshold for PT at >12 to 48 hours of
age, inclusive
- Randomization and treatment cannot take place until the infant is within 1 mg/dl
below the threshold for PT per the AAP Guidelines at up to 12 hours of age or within
2 mg/dL below the threshold for PT at >12 to 48 hours of age, inclusive
Exclusion Criteria:
- Treatment or need for treatment in the neonate with medications that may prolong the
QT interval, family history of Long QT syndrome or family history of Sudden Infant
Death Syndrome
- Risk factors for porphyrias, including family history
- Apgar score ≤6 at age 5 minutes
- Significant congenital anomalies or infections
- Cardiorespiratory distress
- Any abnormal auditory or ophthalmologic findings
- Any excess risk of requiring surgery or exposure to operating room lights in the
foreseeable future
- Clinically significant abnormalities on screening laboratory evaluation
- Use of photosensitizing drugs or agents
- Use of intravenous immunoglobulin (IVIG) or albumins
- Other serious morbid conditions, eg, pulmonary disease, cardiovascular disease
|
| NCT ID: |
|
NCT00850993 |
| Primary Contact: |
|
Principal Investigator
M. Jeffrey Maisels, MB, BCh
William Beaumont Hospitals
Warren W. Wasiewski, M.D.
Phone: 267.515.5861
Email: wwasiewski@infacare.com
|
| Backup Contact: |
|
N/A |
| Location Contact: |
|
Royal Oak, Michigan 48073
United States
There is no listed contact information for this specific location.
Site Status: Withdrawn |
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
June 18, 2013 |
| Modifications to this listing: |
|
Only selected fields are shown, please use the link
below to view all information about this clinical trial. |
|
Click to view Full Listing
|