Sincalide (Cholecystokinin Octapeptide) Versus Placebo in Neonates at High Risk for Developing Parenteral Nutrition Associated Cholestasis

2014-08-27 03:58:14 | BioPortfolio


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.


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.

Study Design

Allocation: Randomized, Control: Placebo Control, Masking: Double-Blind, Primary Purpose: Treatment






Johns Hopkins Oncology Center
United States




FDA Office of Orphan Products Development

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:58:14-0400

Clinical Trials [52 Associated Clinical Trials listed on BioPortfolio]

ABCB4 Gene Mutations in Intrahepatic Cholestasis of Pregnancy and Controls

Mutations of the ATP binding cassette subfamily B member 4 (ABCB4) gene, a gene involved in a subtype of progressive familial intrahepatic cholestasis, have been reported in women sufferin...

Role of Complete Blood Picture in Predicting the Etiology of Extrahepatic Cholestasis

Cases with extrahepatic cholestasis are common and faced during day to day clinical practice, however reaching the final etiology is sometimes challenging and needs investigations which ar...

Inter-regional Cohort of Neonatal and Infant Cholestasis in the Greater Southwest Region

The goal of the study is to characterize the epidemiologic data of the neonatal and infant cholestasis.

A4250, an IBAT Inhibitor in Pediatric Cholestasis

This study will evaluate A4250 (IBATinhibitor) as a treatment option in pediatric patients with chronic cholestasis with main emphasis on safety evaluation and on effects on pruritus

Efficacy and Safety of Maralixibat (SHP625) in the Treatment of Participants With Progressive Familial Intrahepatic Cholestasis (PFIC)

The purpose of this study is to determine if the investigational treatment (maralixibat) is safe and effective in children and adolescents with Progressive Familial Intrahepatic Cholestasi...

PubMed Articles [75 Associated PubMed Articles listed on BioPortfolio]

Adjuvant Use of Rifampin for Refractory Intrahepatic Cholestasis of Pregnancy.

Intrahepatic cholestasis of pregnancy is an incompletely understood disease that poses significant fetal risks, including stillbirth. Treatment of intrahepatic cholestasis of pregnancy is aimed at rel...

The ileum-liver Farnesoid X Receptor signaling axis mediates the compensatory mechanism of 17α-ethynylestradiol-induced cholestasis via increasing hepatic biosynthesis of chenodeoxycholic acids in rats.

Estrogen-induced intrahepatic cholestasis is one of the most common pathogenic factors for liver diseases in clinic. It is, however, regrettable that effective medical therapies to ameliorate or rever...

Paeonia lactiflora Pall. regulates the NF-κB-NLRP3 inflammasome pathway to alleviate cholestasis in rats.

Cholestasis is a critical risk factor for severe hepatic disease or cirrhosis. The anti-inflammatory effect of Paeonia lactiflora Pall. (PLP), named Chishao in traditional Chinese medicine (TCM), on a...

Neonatal Cholestasis: A Primer of Selected Etiologies.

Cholestasis refers to impairment in formation or excretion of bile. This can be due to defects in intrahepatic production of bile, defects in the transmembrane transport of bile, or mechanical obstruc...

Inactivation of Caspase 8 in liver parenchymal cells confers protection against murine obstructive cholestasis.

The cystein-aspartate protease Caspase 8 (CASP8) is the apical initiator caspase in death receptor (DR)-mediated apoptosis. Strong evidence for a link between death receptor (DR)-signaling pathways an...

Medical and Biotech [MESH] Definitions

Impairment of bile flow due to obstruction in small bile ducts (INTRAHEPATIC CHOLESTASIS) or obstruction in large bile ducts (EXTRAHEPATIC CHOLESTASIS).

JAUNDICE, the condition with yellowish staining of the skin and mucous membranes, that is due to impaired BILE flow in the BILIARY TRACT, such as INTRAHEPATIC CHOLESTASIS, or EXTRAHEPATIC CHOLESTASIS.

An ATP-binding cassette, sub-family B protein (P-glycoproteins) that functions in the ATP-dependent secretion of BILE SALTS into the BILE CANALICULI of HEPATOCYTES. Mutations in the ABCB11 gene are associated with progressive familial intrahepatic cholestasis 2 (see CHOLESTASIS, INTRAHEPATIC).

A derivative of benzodiazepine that acts on the cholecystokinin A (CCKA) receptor to antagonize CCK-8's (SINCALIDE) physiological and behavioral effects, such as pancreatic stimulation and inhibition of feeding.

Impairment of bile flow in the large BILE DUCTS by mechanical obstruction or stricture due to benign or malignant processes.

More From BioPortfolio on "Sincalide (Cholecystokinin Octapeptide) Versus Placebo in Neonates at High Risk for Developing Parenteral Nutrition Associated Cholestasis"

Quick Search


Relevant Topics

Blood is a specialized bodily fluid that delivers necessary substances to the body's cells (in animals) – such as nutrients and oxygen – and transports waste products away from those same cells.  In vertebrates, it is composed of blo...

Women's Health
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...

Searches Linking to this Trial