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Cholestasis clinical trials

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NCT ID: NCT03072667 Approved for marketing - Liver Diseases Clinical Trials

Omegaven for Compassionate Use in the Treatment of Parenteral Nutrition-Associated Liver Disease

Start date: n/a
Phase:
Study type: Expanded Access

This is a compassionate use protocol of an investigational new drug (IND). The overall purpose of the treatment is to offer alternative treatment to children who developed parenteral nutrition-associated liver disease (PNALD) and have not responded positively to currently available medical therapies. PNALD develops in newborns dependent on parenteral nutrition (PN) and are unable to tolerate adequate enteral feedings to support fluid and nutritional fluids; although PN is necessary and life sustaining, it can result in severe liver disease.

NCT ID: NCT03056274 Not yet recruiting - Clinical trials for Pregnancy Complications

Metformin in Intrahepatic Cholestasis of Pregnancy

METRIC
Start date: January 2019
Phase: Phase 2/Phase 3
Study type: Interventional

This is a pilot study aimed at comparing the effect of metformin versus ursodeoxycholic acid in women with intrahepatic cholestasis in pregnancy. The study will be conducted in three NHS hospital sites, over an 18 month period.

NCT ID: NCT03030573 Recruiting - Clinical trials for Bile Duct Obstruction, Extrahepatic

Reconstruction of the Bile Duct With the Round Ligament

Start date: November 2015
Phase: N/A
Study type: Interventional

The investigators developed a new surgical technique in order to reconstruct the bile duct with the round ligament

NCT ID: NCT02966834 Completed - Cholestasis Clinical Trials

Dose Response Study of GSK2330672 for the Treatment of Pruritus in Participants With Primary Biliary Cholangitis

Start date: January 11, 2017
Phase: Phase 2
Study type: Interventional

This study is being conducted to evaluate the efficacy, safety and tolerability of GSK2330672 administration for the treatment of pruritus (itch) in participants with primary biliary cholangitis (PBC). Participants will receive either placebo or one of the 4 dose regimens of GSK2330672 (20 milligram [mg], 90 mg or 180 mg taken once daily or 90 mg twice daily). Participants on GSK2330672 will also receive placebo tablets to maintain blinding. The study has a prospectively defined adaptive design that will utilize interim data to further inform and potentially optimize the doses under investigation. Hence, additional dose regimen may be added during study. The total duration of a participant in the study will be up to 45 days of screening and 24 weeks of study including follow-up.

NCT ID: NCT02963077 Completed - Clinical trials for Primary Biliary Cirrhosis

A Safety and Pharmakokinetic Study of A4250 Alone or in Combination With A3384

Start date: July 2013
Phase: Phase 1
Study type: Interventional

The primary objectives of the study are to evaluate the safety, tolerability and pharmacokinetics of A4250 after single or multiple oral doses in healthy subjects. In addition, will evaluate A4250 in combination with cholestyramine.

NCT ID: NCT02936596 Recruiting - Cholestasis Clinical Trials

Remission Induction of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome

Start date: December 2016
Phase: N/A
Study type: Interventional

Biochemical response of primary biliary cholangitis-autoimmune hepatitis overlap syndrome induced by ursodeoxycholic acid only or combination therapy of immunosuppressive agents

NCT ID: NCT02929303 Approved for marketing - Clinical trials for Total Parenteral Nutrition-induced Cholestasis

Expanded Access of Omegaven IV Fat Emulsion to Infants and Children With PNALD

Start date: n/a
Phase:
Study type: Expanded Access

This is an expanded access protocol for use of intravenous fish oil infusion, Omegaven, in infants and children with parenteral nutrition associated liver disease (PNALD) to decrease elevated liver enzymes and direct bilirubin. This study aims to describe the response of PNALD after use of Omegaven by normalization of serum levels of liver enzymes and bilirubin.

NCT ID: NCT02922751 Active, not recruiting - Portal Hypertension Clinical Trials

FibroScan™ in Pediatric Cholestatic Liver Disease (FORCE)

FORCE
Start date: November 16, 2016
Phase:
Study type: Observational

Noninvasive monitoring of liver fibrosis is an unmet need within the clinical management of pediatric chronic liver disease. While liver biopsy is often used in the initial diagnostic evaluation, subsequent biopsies are rarely performed because of inherent invasiveness and risks. This study will evaluate the role of non-invasive FibroScan™ technology to detect and quantify liver fibrosis.

NCT ID: NCT02917408 Completed - Liver Cirrhosis Clinical Trials

Retrospective Study About Primary Biliary Cholangitis During January 2001 to July 2016 at West China Hospital

Start date: September 2016
Phase:
Study type: Observational

Retrospective study of all patients diagnosed with primary biliary cholangitis during January 2001 to July 2016 at West China Hospital by review of medical records. The following variables will be retrospectively studied: age, sex, first symptoms, clinical characteristics, pathology, treatment, stage, complications of cirrhosis, other autoimmune diseases and long-term outcome.

NCT ID: NCT02801981 Completed - Cholestasis Clinical Trials

Dose-escalation Study of GSK2330672 in Japanese Healthy Male Volunteers

Start date: June 2016
Phase: Phase 1
Study type: Interventional

This study will be the first to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics following single dose of 10 milligrams (mg) to 180 mg of GSK2330672 in Japanese healthy subjects. This is a double-blind, randomized, placebo-controlled, dose-escalating and incomplete block crossover study to be conducted in 16 Japanese healthy subjects. Study will be conducted in four periods; subjects will receive either placebo or GSK2330672 (10 mg, 30 mg, 90 mg or 180 mg based on randomization) in each treatment period. Each period will be separated by washout period (at least 6 days from dosing). Total duration of study for each subject will be approximately 5 weeks from the first dosing to follow up visit.