A clinical trial to study the effects of Stannsoporfin in neonates with hyperbilirubenemia
- Registration Number
- CTRI/2010/091/000490
- Lead Sponsor
- InfaCare Pharmaceutical Corporation, 8 Neshaminy Interplex, Suite 221Trevose, PA 19053-6944, USA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 72
1. Term and late preterm subjects
2. Risk factors for hemolytic disease to include ABO blood type incompatibility or Rh incompatibility (anti-C, c, D, E, or e)
3. A minimum birth weight of 2500 g (5.5 lbs)
4. Within 2 mg/dL below the 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
1. Family history of glucose-6-phosphate dehydrogenase (G6PD) deficiency
2. Clinical suggestion of neonatal thyroid disease or current uncontrolled thyroid disease in the mother (maternal Hashimoto?s disease is not exclusionary)
3. 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
4. Risk factors for porphyrias, including family history
5. Apgar score ≤6 at age 5 minutes
6. Significant congenital anomalies or infections
7. Cardiorespiratory distress
8. Any abnormal auditory or ophthalmologic findings
9. Any excess risk of requiring surgery or exposure to operating room lights in the foreseeable future
10. Clinically significant abnormalities on screening laboratory evaluation
11. Use of photosensitizing drugs or agents
12. Use of intravenous immunoglobulin (IVIG) or albumins
13. Other serious morbid conditions, eg, pulmonary disease, cardiovascular disease
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the safety of 3 ascending doses of stannsoporfin in subjects with hyperbilirubinemiaTimepoint: First 30 days after injection
- Secondary Outcome Measures
Name Time Method To determine the efficacy and pharmacokinetics of 3 ascending doses of stannsoporfinTimepoint: Up to 14 days following injection