Stannsoporfin With Light Therapy for Newborn Babies With Jaundice

NCT01887327 | Completed Phase 2 Results

• 1 other identifier: 64,185-204
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 18

Brief Summary

It is normal for red blood cells to die, even in newborn babies. The waste from that is called bilirubin. The liver clears bilirubin out of the body. Some babies are born with illness that makes red blood cells die too fast, so the liver is not strong enough to keep up with it. The yellowish color in eyes or skin means there is too much bilirubin in the body. It can be dangerous if a baby's bilirubin gets too high. Special lights are put on jaundiced babies (called phototherapy) to help the liver get rid of bilirubin. This study tests an experimental drug to see if it can help the liver even more, by safely cutting down the amount of bilirubin the body is making in the first place.

Conditions

Jaundice, Neonatal; Hyperbilirubinemia, Neonatal

Keywords

G6PD deficiency; Antibody (ABO) incompatibility; Coombs positive ABO/ rhesus factor (RH) incompatibility; Intensive phototherapy in neonates

Outcome Measures

Primary Outcomes (1)

• Total Serum Bilirubin (mg/dL)

  Total serum bilirubin (TSB) was measured at baseline (the measure that qualified the baby for inclusion) and at 48 hours after treatment. If a baby was discharged before 48 hours, the last measurement before discharge was used \[last observation carried forward (LOCF)\].

  Baseline, 48 hours post-treatment

Secondary Outcomes (3)

• Time (Hour) at Which TSB First Crosses at or Below the Defined Age-specific Threshold for 54-hours Post-treatment (PT)

  within 54 hours

• Number of Participants With Phototherapy (PT) Failure

  within 30 days after discharge

• Number of Participants With Rebound Hyperbilirubinemia

  within 54 hours

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Participants receive placebo and phototherapy

Procedure: Phototherapy; Drug: Placebo

Stannsoporfin 3.0 mg/kg

EXPERIMENTAL

Participants receive stannsoporfin (3.0 mg/kg) and phototherapy

Procedure: Phototherapy; Drug: Stannsoporfin

Stannsoporfin 4.5 mg/kg

EXPERIMENTAL

Participants receive stannsoporfin (4.5 mg/kg) and phototherapy

Procedure: Phototherapy; Drug: Stannsoporfin

Interventions

Phototherapy PROCEDURE

Phototherapy starts within 30 minutes before or after injection

Also known as: Light therapy

Placebo; Stannsoporfin 3.0 mg/kg; Stannsoporfin 4.5 mg/kg

Stannsoporfin DRUG

Stannsoporfin (3.0 or 4.5 mg/kg) administered by intramuscular (IM) injection (a shot in the muscle)

Also known as: Experimental drug

Stannsoporfin 3.0 mg/kg; Stannsoporfin 4.5 mg/kg

Placebo DRUG

Matching placebo administered by IM injection

Also known as: Matching placebo, Saline

Placebo

Eligibility Criteria

• Age: 1 Hour - 72 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Term and near term infants ≥35 and ≤ 43 weeks gestational age (GA), age 0-48 hours with antibody (ABO) or rhesus factor (Rh) incompatibility (anti C, c, D, E or e) who are Coombs positive, or age 0-72 hours with G6PD deficiency
• Parental or guardian consent
• Birth weight ≥ 2500 grams
• At or above the age-specific threshold for initiating phototherapy (PT) per the American Academy of Pediatrics (AAP) guidelines based on measurement of total serum bilirubin (TSB)
• Parents agree to observe light precautions for 10 days post treatment

You may not qualify if:

• Elevated direct bilirubin ≥2 mg/dL, OR \> 20% of the total serum bilirubin
• Alanine aminotransferase (ALT) \> 2 times the upper limit of normal (ULN) and/or aspartate aminotransferase (AST) \> 3 times ULN
• Abnormal renal function defined as creatinine and/or blood urea nitrogen \>2 times the ULN
• Any other clinically significant abnormalities on screening laboratory evaluation \[including electrocardiogram (ECG)\] that in the opinion of the investigator makes the patient unsuitable for the clinical trial
• Apgar score ≤6 at age 5 minutes
• An unexplained existing rash or skin erythema
• Prior exposure to PT
• Cardio-respiratory distress, defined as a respiratory rate \>60 breaths per minute at time of enrollment
• Any abnormal auditory or ophthalmologic findings on screening physical exam
• Treatment or need for treatment in the neonate with medications that are photoreactive or may prolong the QT interval (erythromycin ointment for eye prophylaxis is permitted), or family history of Long QT syndrome
• Known porphyrias or risk factors for porphyrias, including family history
• A maternal history of systemic lupus erythematosus
• Maternal use of phenobarbital 30 days before, or after delivery, if breast-feeding
• Maternal current drug or alcohol abuse, or maternal history of drug or alcohol abuse that, in the opinion of the Investigator, would not make the patient a suitable candidate for participation in the clinical trial
• Significant congenital anomalies or infections

Sponsors & Collaborators

• InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company: lead

Study Sites (18)

Arrowhead Regional Medical Center

Colton, California, 92324, United States

Location

University of California San Diego Medical Center

San Diego, California, 92103, United States

Location

University of CA, San Francisco

San Francisco, California, 94145, United States

Location

Univ Florida Hospital

Jacksonville, Florida, 32209, United States

Location

Kosair Children's Hospital

Louisville, Kentucky, 40202, United States

Location

University of Louisville Hospital

Louisville, Kentucky, 40202, United States

Location

Univ Med Ctr of Southern Nevada

Las Vegas, Nevada, 89102, United States

Location

Rutgers University Hospital

Newark, New Jersey, 07103, United States

Location

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

Stoney Brook Univ Hospital

Stony Brook, New York, 22794, United States

Location

WakeMed Health and Hospitals

Raleigh, North Carolina, 27610, United States

Location

Toledo Children's Hospital

Toledo, Ohio, 43606, United States

Location

Hahnemann University Hospital/St. Christopher's Hospital for Children

Philadelphia, Pennsylvania, 19102, United States

Location

Medical Univ of South Carolina

Charleston, South Carolina, 29425, United States

Location

University of Tennessee Health Science Center

Memphis, Tennessee, 38163, United States

Location

JPS Health Network

Fort Worth, Texas, 76104, United States

Location

Univ Texas Medical Branch

Galveston, Texas, 77555, United States

Location

Children's Hospital of Richmond at VCU

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Jaundice, Neonatal; Hyperbilirubinemia, Neonatal; Glucosephosphate Dehydrogenase Deficiency

Interventions

Phototherapy; tin mesoporphyrin; Drugs, Investigational; Sodium Chloride

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Genetic Diseases, Inborn; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Medical Information Call Center
• Organization: Mallinckrodt Pharmaceuticals

ClinicalTrials@mnk.com

800-556-3314

Study Officials

• Global Clinical Leader

  InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2013
• First Posted: June 26, 2013
• Study Start: October 16, 2013
• Primary Completion: March 22, 2016
• Study Completion: March 22, 2016
• Last Updated: February 6, 2020
• Results First Posted: November 13, 2019

Record last verified: 2020-02

Locations

US (18)