NCT00115544

Brief Summary

The purpose of this study is to evaluate the effect and safety of Stanate (stannsoporfin) in infants who are at risk for an exchange transfusion and meet the criteria of the protocol.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2005

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 23, 2005

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2005

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

October 15, 2019

Status Verified

February 1, 2016

Enrollment Period

10 months

First QC Date

June 22, 2005

Last Update Submit

October 11, 2019

Conditions

Hyperbilirubinemia

Keywords

neonataljaundicehyperbilirubinemia

Outcome Measures

Primary Outcomes (1)

  • Reduction of serum bilirubin levels; need for exchange transfusion, safety parameters

    30 days with long term f/u

Study Arms (3)

1

EXPERIMENTAL

stannsoporfin 0.75mg/kg

Drug: Stanate

2

EXPERIMENTAL

stannsoporfin 1.5mg/kg

Drug: Stanate

3

PLACEBO COMPARATOR

saline injection

Drug: Stanate

Interventions

StanateDRUG

Intramuscular injection of stannsoporfin at 0.75 or 1.5mg/kg for treatment of severe hyperbilirubinemia to prevent exchange transfusion

123

Eligibility Criteria

Age2 Days - 7 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Term and near-term healthy infants (may be no more than 14 days of age) with excessive hyperbilirubinemia who are at risk for exchange transfusion according to the AAP guidelines of 2004

You may not qualify if:

  • No parental consent
  • Major known congenital anomaly
  • Current use of antibiotics, cardio-respiratory instability, abnormal renal function, hepatitis (as related to TORCH infections)
  • Phenobarbital use in either child or mother (30 days prior to child's birth)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National hospital of pediatrics

Hanoi, Vietnam

Location

MeSH Terms

Conditions

HyperbilirubinemiaJaundice

Interventions

tin mesoporphyrin

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2005

First Posted

June 23, 2005

Study Start

September 1, 2005

Primary Completion

July 1, 2006

Study Completion

July 1, 2006

Last Updated

October 15, 2019

Record last verified: 2016-02

Locations

VN(1)