Sincalide (Cholecystokinin Octapeptide) Versus Placebo in Neonates at High Risk for Developing Parenteral Nutrition Associated Cholestasis
Information source: FDA Office of Orphan Products Development
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cholestasis
Intervention: sincalide (Drug)
Phase: N/A
Status: Completed
Sponsored by: FDA Office of Orphan Products Development Official(s) and/or principal investigator(s):
Daniel Hillel Teitelbaum, Study Chair, Affiliation: University of Michigan
Summary
OBJECTIVES: I. Compare conjugated bilirubin levels and serum bile acid levels in severely
premature newborns on long term parenteral nutrition and given either sincalide or placebo.
II. Compare morbidity and mortality rates in this patient population. III. Evaluate
ultrasonographic images of the hepatobiliary tree during and 1 to 2 years after the
administration of sincalide or placebo to assess the development of biliary sludge and
biliary stone formation.
Clinical Details
Study design: Treatment, Randomized, Double-Blind, Placebo Control
Detailed description:
PROTOCOL OUTLINE: This is a randomized, placebo controlled, double blind, multicenter study.
Patients are stratified according to prematurity or surgical group.
Patients are randomized to receive either placebo or sincalide IV over 10 to 15 minutes every
12 hours until a total of 8 weeks of therapy is administered or greater than 50% of their
nutrition is enteral.
Patients are followed for a maximum of 2 years.
Eligibility
Minimum age: N/A.
Maximum age: 30 Days.
Gender(s): Both.
Criteria:
PROTOCOL ENTRY CRITERIA:
- -Disease Characteristics-- Severely premature neonates (less than 1000 g at birth and
estimated gestational age of no greater than 28 weeks) that require greater than 50% of
caloric requirements by parenteral means within 7 days of birth OR Neonates with one or
more of the following surgical conditions: Necrotizing enterocolitis Gastroschisis Severe
jejunal-ileal atresia within 7 days of diagnosis - -Prior/Concurrent Therapy-- Biologic
therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified
Radiotherapy: Not specified Surgery: See Disease Characteristics No other cardiovascular
(thoracotomy) or major gastrointestinal surgery (laparotomy) during the newborn period
Other: No prior or concurrent ursodeoxycholic acid No concurrent use of extracorporeal life
support - -Patient Characteristics-- Performance status: Not specified Hematopoietic: Not
specified Hepatic: Conjugated bilirubin no greater than 1. 0 mg/dL No primary or secondary
liver disease No hepatic insufficiency as documented by either a biopsy with cirrhosis or
elevated prothrombin time without evidence of systemic coagulopathy and no administration
of an anticoagulant Renal: No renal failure as indicated by a progressive increase in
creatinine levels Other: No hemodynamic instability No documented communicable infection
(including infectious hepatitis or HIV) No metabolic pathway defect that is associated with
liver dysfunction in the neonatal period including hereditary fructose intolerance,
galactosemia due to transferase deficiency, and neonatal tyrosinemia
Locations and Contacts
Johns Hopkins Oncology Center, Baltimore, Maryland 21231, United States
University of Michigan Medical School, Ann Arbor, Michigan 48109-0718, United States
University of Rochester Medical Center, Rochester, New York 14642, United States
Children's Hospital Medical Center - Cincinnati, Cincinnati, Ohio 45229-3039, United States
Rhode Island Hospital, Providence, Rhode Island 02903, United States
Baylor University Medical Center, Dallas, Texas 75246, United States
Additional Information
Starting date: September 1997
Last updated: September 6, 2006
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