Observational Follow-up of Participants From Clinical Trial 64,185-202 (NCT00850993)

NCT02033096 | Completed

• 1 other identifier: 64,185-203
• Study Type: observational
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief Summary

Observational follow-up of participants from earlier interventional trial 64,185-202 (NCT00850993). No interventions were administered during this follow-up study.

Conditions

Jaundice; Neonatal Hyperbilirubinemia

Keywords

stannsoporfin; hyperbilirubinemia; heme oxygenase

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events

  within 52 months

Study Arms (4)

Cohort 1: Stannsoporfin 1.5 mg/kg

Cohort 1: Received one 1.5 mg/kg stannsoporfin injection (with phototherapy as needed) during participation in an earlier interventional trial (NCT00850993)

Drug: Stannsoporfin; Other: Phototherapy (as needed)

Cohort 2: Stannsoporfin 3.0 mg/kg

Cohort 2: Received one 3.0 mg/kg stannsoporfin injection (with phototherapy as needed) during participation in an earlier interventional trial (NCT00850993)

Drug: Stannsoporfin; Other: Phototherapy (as needed)

Cohort 3: Stannsoporfin 4.5 mg/kg

Cohort 3: Received one 4.5 mg/kg stannsoporfin injection (with phototherapy as needed) during participation in an earlier interventional trial (NCT00850993)

Drug: Stannsoporfin; Other: Phototherapy (as needed)

Cohort 4: Placebo Control

Cohort 4: Received one sterile saline injection (with phototherapy as needed) during participation in an earlier interventional trial (NCT00850993)

Drug: Placebo Control; Other: Phototherapy (as needed)

Interventions

Stannsoporfin DRUG

No intervention was administered during this observational study

Also known as: Experimental product

Cohort 1: Stannsoporfin 1.5 mg/kg; Cohort 2: Stannsoporfin 3.0 mg/kg; Cohort 3: Stannsoporfin 4.5 mg/kg

Placebo Control DRUG

No intervention was administered during this observational study

Also known as: Saline

Cohort 4: Placebo Control

Phototherapy (as needed) OTHER

No intervention was administered during this observational study

Also known as: Standard Care

Cohort 1: Stannsoporfin 1.5 mg/kg; Cohort 2: Stannsoporfin 3.0 mg/kg; Cohort 3: Stannsoporfin 4.5 mg/kg; Cohort 4: Placebo Control

Eligibility Criteria

• Age: 30 Days - 4 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Babies who participated in protocol 64,185-202 (NCT00850993)

You may qualify if:

• Participants who received treatment in clinical trial 64,185-202 and for whom informed consent was given for long term safety followup

You may not qualify if:

• Participants were excluded by the investigator for medical reasons or by parents/guardians withdrawing consent

Sponsors & Collaborators

• InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company: lead

MeSH Terms

Conditions

Jaundice; Hyperbilirubinemia, Neonatal; Hyperbilirubinemia

Interventions

tin mesoporphyrin; Sodium Chloride; Phototherapy; Standard of Care

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Therapeutics; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Clinical Study Leader

  Mallinckrodt

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2014
• First Posted: January 10, 2014
• Study Start: October 20, 2008
• Primary Completion: June 23, 2015
• Study Completion: November 9, 2015
• Last Updated: October 15, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share