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Cholestasis

Part of Bile Duct Diseases

2 published articles · Updated continuously

Clinical Trial Landscape

Clinical Trials for Cholestasis

14 trials tracked for Cholestasis: 5 in phase 3 or 4 and 2 with published results. The most-cited published study has 217 citations.

14Trials tracked

5Phase 3 & 4

0Recruiting

2With published results

Phase distribution

Phase 3 5 Phase 2 3 Phase 1 4 Other / NA 2

Phase 3 Effectiveness of Multicomponent Lipid Emulsion in Preterm Infants Requiring Parenteral Nutrition Completed · 217 cited
Phase 3 Compassionate Treatment of Patients With Inborn Errors of Bile Acid Metabolism With Cholic Acid Completed · 65 cited
Phase 3 Compassionate Use of Omegaven in Children Completed
Phase 3 Standard Lipid Therapy vs IVFE Minimization for Prevention of PNALD Completed
Phase 3 Omegaven as Alternative Parenteral Fat Nutrition Completed
Phase 2 Evaluation of Omegaven™ Parenteral Nutrition in Patients With Total Parenteral Nutrition (TPN)-Induced Cholestasis Completed

Show 8 more trials

Phase 2 Open-Label Study of HTD1801 in Adult Subjects With Primary Biliary Cholangitis Completed
Phase 2 Dose Response Study of GSK2330672 for the Treatment of Pruritus in Participants With Primary Biliary Cholangitis Completed
Phase 1 Pharmacokinetics (PKs) and Metabolism of Radiolabelled Linerixibat Completed
Phase 1 Biliary Excretion of Conjugated Bile Acids in Humans Measured by 11C-cholylsarcosine PET/CT Completed
Phase 1 Linerixibat and Obeticholic Acid Drug Interaction Study in Healthy Subjects Completed
Phase 1 Evaluate the Safety, Tolerability, and PK of EP547 in Healthy Subjects and Subjects With Cholestatic or Uremic Pruritus Completed
N/A Compassionate Use of Omegaven to Reverse Parenteral Nutrition Induced Cholestasis Completed
N/A Compassionate Use of an Intravenous Fish Oil Emulsion in the Treatment of Liver Injury in Infants Completed

Showing the 14 most-cited and recently-updated of 14 trials. Browse the full registry →

Trial data sourced from ClinicalTrials.gov. Counts describe the research landscape and are not a treatment recommendation. Informational only — not medical advice.

What the trials found For clinicians

Cholestasis: what the trials found

Multiple trials evaluated the use of Omegaven as an intervention for this condition, with consistent results across several studies [8, 13, 14]. Additionally, multicomponent lipid emulsions and Cholic Acids were established interventions in clinical trials [1, 2].

Clinical data also assessed Intralipid 20% I.V. Fat Emulsion. In this cohort, there were no statistically significant differences observed in the prevalence of Parenteral Nutrition-associated Cholestasis (PNAC) (p=0.617), the prevalence of severe PNAC (p=0.450), or the time to development of PNAC (p=0.2716) ⁴.

Recent results — preliminary, needs further review

* HTD1801 (BUDCA) showed a non-significant reduction in Alkaline Phosphatase (ALP) at week 12 (p=0.077) ⁶. * EP547 was evaluated in a Phase 1 study ⁹. * GSK2330672 (linerixibat) was evaluated in a Phase 1 study ¹⁰. * Linerixibat tablets were assessed for absorption and urinary excretion in a Phase 1 trial ¹¹. * 11C-CSar was used to quantify hepatic transport in a Phase 1 trial ¹².

For the clinician treating this condition

Omegaven, multicomponent lipid emulsions, and Cholic Acids are established interventions for this condition.
Intralipid 20% I.V. Fat Emulsion did not show statistically significant differences in the incidence or timing of PNAC compared to standard measures.

AI synthesis of 6 cited trials, updated Jun 29, 2026. Informational only — not medical advice; trial data sourced from ClinicalTrials.gov. How we use AI.