Cholestasis
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Sign up freeTop drugs studied for this disease
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CLINICAL_TRIALS trial_result · 2019-11-25Clinical Trial Update: Compassionate Use of Omegaven in Children [Phase 2, Phase 3]
A completed compassionate-use trial update for Omegaven in children with parenteral nutrition-associated cholestasis, with Phase 2 and Phase…
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CLINICAL_TRIALS trial_result · 2019-10-28Clinical Trial Update: Evaluation of Omegaven™ Parenteral Nutrition in Patients With Total Parenteral Nutrition (TPN)-Induced Cholestasis [Phase 2]
Phase 2 trial evaluating Omegaven for TPN-induced cholestasis (PNALD) has completed with results posted.
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FDA approval · 2018-07-27FDA Approved: OMEGAVEN — Original Application (Fresenius Kabi USA, LLC)
FDA approved OMEGAVEN, a fish oil-based parenteral lipid emulsion, under original NDA 210589 (Fresenius Kabi USA, LLC).
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CLINICAL_TRIALS trial_result · 2018-07-17Clinical Trial Update: Fibrates in Pediatric Cholestasis [Phase 2]
Phase 2 trial update on using fibrates for pediatric cholestasis; the study has completed.
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CLINICAL_TRIALS trial_result · 2018-01-09Clinical Trial Update: Preventing Cholestasis Using SMOFLipid® [Phase 4]
Phase 4 clinical trial update evaluating SMOFLipid for preventing cholestasis.
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CLINICAL_TRIALS withdrawal · 2017-12-08Clinical Trial Update: Compassionate Use of Omegaven IV Fat Emulsion
Compassionate-use access to Omegaven IV fat emulsion for cholestasis and liver disease is no longer available.
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CLINICAL_TRIALS trial_result · 2017-10-13Clinical Trial Update: Gabapentin to Treat Itch in Patients With Liver Disease [Phase 3]
This update reports the completion of a Phase 3 trial evaluating gabapentin to treat itch in patients with liver disease.
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CLINICAL_TRIALS trial_result · 2017-08-01Clinical Trial Update: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Repeat Doses of GSK2330672 Administration in Subjects With Primary Biliary Cirrhosis (PBC) and Symptoms of Pruritus [Phase 2]
A Phase 2 study assessed safety, tolerability, pharmacokinetics and pharmacodynamics of repeated doses of GSK2330672 in adults with primary …
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CLINICAL_TRIALS trial_result · 2017-05-31Clinical Trial Update: Effectiveness of Multicomponent Lipid Emulsion in Preterm Infants Requiring Parenteral Nutrition [Phase 3]
A Phase 3 trial evaluating the effectiveness of a multicomponent lipid emulsion in preterm infants requiring parenteral nutrition for choles…
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CLINICAL_TRIALS trial_result · 2017-04-17Clinical Trial Update: SMOFlipid to Lessen the Severity of Neonatal Cholestasis [Phase 1, Phase 2]
A University of Florida trial evaluating SMOFlipid to lessen the severity of neonatal cholestasis in Phase 1/2 has been terminated, with res…
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CLINICAL_TRIALS trial_result · 2016-11-09Clinical Trial Update: Dose-escalation Study of GSK2330672 in Japanese Healthy Male Volunteers [Phase 1]
Phase 1 dose-escalation study of GSK2330672 in Japanese healthy male volunteers for cholestasis has completed.
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CLINICAL_TRIALS trial_result · 2016-10-03Clinical Trial Update: Cholestasis in Extreme Low Birth Weight Infants (ELBW)
A clinical trial update indicates that a study on cholestasis in extreme low birth weight infants has completed.
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CLINICAL_TRIALS withdrawal · 2016-06-21Clinical Trial Update: Enteral Fish Oil is Superior to Ursodeoxycholic Acid (UDCA) and Placebo for the Treatment of Cholestasis in Infants [Phase 2]
The Phase 2 trial evaluating enteral fish oil for cholestasis in infants has been withdrawn.
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CLINICAL_TRIALS trial_result · 2016-06-16Clinical Trial Update: Low Dose Fat for the Prevention of Liver Disease in Babies With Gastrointestinal Disorders [Phase 4]
A Phase 4 trial evaluating low-dose fat to prevent liver disease in infants with cholestasis and related gastrointestinal disorders was term…
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CLINICAL_TRIALS trial_result · 2016-05-11Clinical Trial Update: Prospective Multicenter Evaluation of a New Short-access-cholangioscope for Biliary Duct Strictures and Gall Stones [NA]
A multicenter prospective evaluation of a new short-access cholangioscope for biliary duct strictures and gall stones has completed.
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CLINICAL_TRIALS trial_result · 2016-05-10Clinical Trial Update: Inter-regional Cohort of Neonatal and Infant Cholestasis in the Greater Southwest Region
This clinical trial in neonates and infants with cholestasis, sponsored by University Hospital, Toulouse, has been terminated.
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CLINICAL_TRIALS trial_result · 2016-02-09Clinical Trial Update: Compassionate Use of Omegaven IV Fat Emulsion [Phase 2]
Phase 2 compassionate-use trial of Omegaven IV fat emulsion for cholestasis, including total parenteral nutrition-induced cholestasis, was t…
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CLINICAL_TRIALS trial_result · 2015-11-23Clinical Trial Update: Prevention of Parenteral Nutrition-Associated Cholestasis With Cyclic Parenteral Nutrition in Infants [NA]
The clinical trial evaluating cyclic parenteral nutrition to prevent parenteral nutrition-associated cholestasis in infants was terminated.
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FDA approval · 2015-09-10FDA Approved: CHOLETEC — Supplemental Application (Bracco Diagnostics Inc)
FDA approved a supplemental application for CHOLETEC (mebrofenin) submitted by Bracco Diagnostics Inc. This entry notes the supplemental app…
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CLINICAL_TRIALS trial_result · 2015-03-25Clinical Trial Update: Randomized Study of Tauroursodeoxycholic Acid in Prophylactic Therapy of Total Parenteral Nutrition Associated Cholestasis in Infants [NA]
A randomized study evaluated tauroursodeoxycholic acid as prophylaxis for cholestasis in infants receiving total parenteral nutrition; the t…
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CLINICAL_TRIALS trial_result · 2015-03-25Clinical Trial Update: Sincalide (Cholecystokinin Octapeptide) Versus Placebo in Neonates at High Risk for Developing Parenteral Nutrition Associated Cholestasis [NA]
A completed clinical trial comparing sincalide (cholecystokinin octapeptide) to placebo in high-risk neonates to assess prevention of parent…
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CLINICAL_TRIALS trial_result · 2015-02-23Clinical Trial Update: Biliary Excretion of Conjugated Bile Acids in Humans Measured by 11C-cholylsarcosine PET/CT [Phase 1]
Phase 1 study assessing biliary excretion of conjugated bile acids in humans using 11C-cholylsarcosine PET/CT; the trial was completed and r…
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CLINICAL_TRIALS trial_result · 2015-01-08Clinical Trial Update: Omegaven® as Parenteral Nutrition [NA]
Clinical trial update for Omegaven as parenteral nutrition in cholestasis; current status is UNKNOWN.
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CLINICAL_TRIALS trial_result · 2014-05-29Clinical Trial Update: Efficacy and Safety of S-adenosyl-L-methionine in Treatment of Chronic Hepatitis B Patients With Cholestasis [Phase 4]
Phase 4 clinical trial evaluating the efficacy and safety of S-adenosyl-L-methionine in patients with chronic hepatitis B and cholestasis; c…
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CLINICAL_TRIALS trial_result · 2013-12-19Clinical Trial Update: Brain Manganese Deposition in High Risk Neonates
A completed Vanderbilt-led clinical trial investigated brain manganese deposition in high-risk neonates, reporting on conditions including n…