5 completed, 1 approved for marketing, 1 unknown. 3 Not applicable, 3 Phase 3, 1 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Not applicable | 3 | Completed 2, Unknown 1 |
| Phase 3 | 3 | Completed 3 |
| Phase 2 | 1 | Completed 1 |
Follow Cholestasis of Parenteral Nutrition: new trials by email Literature Review of Cholestasis of Parenteral Nutrition trials Research Report on Cholestasis of Parenteral Nutrition
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Ursodeoxycholic Acid Prevents Total Parenteral Nutrition Cholestasis Ursodeoxycholic Acid 250 Mg Oral Capsule - Cholestasis of Parenteral Nutrition | Not applicable | Unknown | Wei Liu | 80 | 2021-01-01 | 2021-09-20 |
| Comparison of Smoflipid to Soy-based Lipid Reduction for Cholestasis Prevention in Surgical Neonates Smoflipid 20% Lipid Emulsion for Injection, Intralipid, 20% Intravenous Emulsion - Cholestasis of Parenteral Nutrition | Phase 3 | Completed | Indiana University | 24 | 2018-11-30 | 2025-07-30 |
| Omegaven as Alternative Parenteral Fat Nutrition Omegaven - Cholestasis, Cholestasis of Parenteral Nutrition | Phase 3 | Completed | University of South Florida | 2 | 2018-10-23 | 2020-07-22 |
| Compassionate Use of Omegaven in Children Omegaven - Total Parenteral Nutrition-induced Cholestasis, Cholestasis | Phase 2 / Phase 3 | Completed | University of Oklahoma | 63 | 2015-06-01 | 2019-11-25 |
| Non Invasive Study of the Hepatic Fibrosis in Paediatrics by the Method of Study of Pediatric Hepatic Fibrosis Elastometry - Cirrhosis, Liver Fibrosis | Not applicable | Completed | Assistance Publique - Hôpitaux de Paris | 264 | 2010-01-19 | 2025-11-20 |
| Compassionate Use of an Intravenous Fish Oil Emulsion in the Treatment of Liver Injury in Infants Omegaven - Cholestasis, Cholestasis of Parenteral Nutrition | Not applicable | Completed | Baylor College of Medicine | 293 | 2008-09-01 | 2021-05-28 |
| Safer Parenteral Nutrition in Pediatric Short Bowel Syndrome to Decrease Liver Damage Omegaven 10% - Cholestasis of Parenteral Nutrition | Approved for marketing | Georgetown University | 2019-05-07 |
Cholestasis (4) · Hyperphagia (2) · Short Bowel Syndrome (2) · Cystic Fibrosis (1) · Fibrosis (1) · Gastroschisis (1) · Hypertension, Portal (1) · Infant, Premature, Diseases (1) · Intestinal Atresia (1) · Intestinal Failure (1) · Liver Cirrhosis (1) · Liver Diseases (1)
Digestive System Diseases (5) · Bile Duct Diseases (4) · Biliary Tract Diseases (4) · Pathological Conditions, Signs and Symptoms (4) · Pathologic Processes (3) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (2) · Gastrointestinal Diseases (2) · Infant, Newborn, Diseases (2) · Intestinal Diseases (2) · Malabsorption Syndromes (2) · Postoperative Complications (2) · Signs and Symptoms (2) · Signs and Symptoms, Digestive (2) · Congenital Abnormalities (1) · Digestive System Abnormalities (1)
fish oil triglycerides (3) · Injections (1) · SMOFlipid (1) · Ursodeoxycholic Acid (1) · soybean oil, phospholipid emulsion (1)
Assistance Publique - Hôpitaux de Paris (1) · Baylor College of Medicine (1) · Georgetown University (1) · Indiana University (1) · University of Oklahoma (1) · University of South Florida (1) · Wei Liu (1)
United States (5) · China (1) · France (1)
Florence Lacaille, MD, PhD (1) · Kimberly D Ernst, MD, MSMI (1) · Murali Premkumar, MD (1) · Thao Ho, DO (1)
PMID 15685546, PMID 16628644, PMID 17133503, PMID 18030211, PMID 23164314, PMID 32059815, PMID 33038344, PMID 34695449