A clinical trial to study the effects of Stannsoporfin in neonates with hyperbilirubenemia

A Phase 2b, Multicenter, Single-dose, Blinded, Randomized, Placebo-controlled, Dose-escalation, Safety and Efficacy Trial of Stannsoporfin in Neonates With Hyperbilirubinemia

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000490

Enrollment

Registered

2011-01-04

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Stannsoporfin(stannate) IM injection: 1.5, 3.0, or 4.5 mg/kg Control Intervention1: Placebo IM injection: 1.5 mg/kg, 3.0 mg/kg and 4.5 mg/kg

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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 &#8804;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

Design outcomes

Primary

Measure	Time frame
To determine the safety of 3 ascending doses of stannsoporfin in subjects with hyperbilirubinemiaTimepoint: First 30 days after injection	—

Secondary

Measure	Time frame
To determine the efficacy and pharmacokinetics of 3 ascending doses of stannsoporfinTimepoint: Up to 14 days following injection	—

Countries

India

Contacts

Public ContactSunil Garg

INC GVKBIO Pvt. Ltd.

sgarg@incresearch.com911244642400

Outcome results