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Cholestasis clinical trials

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NCT ID: NCT06005701 Active, not recruiting - Clinical trials for Patient Satisfaction

Mallampati Score for Prediction and Prognosis of Postoperative Mortality and Morbidity and Safety Profiles of Patients Undergoing Laparoscopic Cholecystectomy in Qassim Region

Start date: January 1, 2022
Phase:
Study type: Observational [Patient Registry]

To predict the majority of Mallampati score for the patients in Qassim region who undergoing Laparoscopic Cholecystectomy Surgery.

NCT ID: NCT05582447 Active, not recruiting - Cholestasis Clinical Trials

Osmotic Fragility in Red Blood Cells of Pediatric Patients With Cholestatic Liver Disease

Start date: April 17, 2018
Phase:
Study type: Observational

Objective: The investigators propose to perform ektacytometry on 20 pediatric patients over age one with cholestatic liver diseases and a direct bilirubin level of greater than 2 gm/dl. The most common diagnoses will be extrahepatic biliary atresia, progressive familial intrahepatic cholestasis, Alagille syndrome, autoimmune hepatitis, primary sclerosing cholangitis, and parenteral nutrition-associated cholestasis. The investigators will correlate the osmotic fragility and deformability with direct bilirubin levels, serum cholesterol levels, serum bile acid levels, and vitamin E levels. Design/Methods: This pilot study will be a single center, prospective cross-sectional investigation of red blood cell ektacytometry in pediatric patients with extrahepatic cholestasis who are followed at Cincinnati Children's Hospital Medical Center. The study will include all participants with cholestasis regardless of the etiology in order to maximize the number of participants. While the population will be heterogeneous, the investigators will stratify participants according to diagnosis, recognizing that only a few participants may fall into each diagnostic category. Ektacytometry will be the method utilized to measure osmotic fragility and deformability of the RBC membrane. The ektacytometry of red cells from cholestatic patients will be compared to that of red cells obtained from contemporaneous age-matched controls recruited among patients without liver disease or red cell membrane defects undergoing blood sampling for evaluation of other entities including but not confined to functional abdominal pain.

NCT ID: NCT05543187 Active, not recruiting - Clinical trials for Progressive Familial Intrahepatic Cholestasis (PFIC)

A Study of TAK-625 for the Treatment of Progressive Familial Intrahepatic Cholestasis (PFIC)

Start date: January 10, 2023
Phase: Phase 3
Study type: Interventional

The main aim of the study is to check if TAK-625 improves symptoms of Progressive Familial Intrahepatic Cholestasis (PFIC), side effect from the study treatment or TAK-625, and how much TAK-625 stays in their blood over time. This will help the study sponsor (Takeda) to work out the best dose to give people in the future. The participants will be treated with TAK-625 for up to the end of study (about 34 months). Participants will visit their study clinic 15 times from the start of study. After 15 times visits, participants will visit their study clinic every 12 weeks up to the end of study.

NCT ID: NCT04787419 Active, not recruiting - Clinical trials for Cholestatic Liver Disease

Probiotics in Pediatric Chronic Cholestasis

Start date: September 1, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

double blinded RCT (probiotics vs placebo) given to pediatric patients with chronic cholestasis for 4 weeks duration. baseline characteristics (antropometry, gastrointestinal symptoms, laboratory examinations) would be compared pre vs post treatment

NCT ID: NCT04729751 Active, not recruiting - Alagille Syndrome Clinical Trials

A Study to Evaluate the Safety and Tolerability of Maralixibat in Infant Participants With Cholestatic Liver Diseases Including Progressive Familial Intrahepatic Cholestasis (PFIC) and Alagille Syndrome (ALGS).

RISE
Start date: September 9, 2021
Phase: Phase 2
Study type: Interventional

This study is designed to assess whether the investigational drug maralixibat, is safe and well tolerated in children <12 months of age with Alagille Syndrome [ALGS] or Progressive Familial Intrahepatic Cholestasis [PFIC].

NCT ID: NCT04185363 Active, not recruiting - Clinical trials for Progressive Familial Intrahepatic Cholestasis (PFIC)

An Extension Study of Maralixibat in Patients With Progressive Familial Intrahepatic Cholestasis (PFIC)

Start date: January 8, 2020
Phase: Phase 3
Study type: Interventional

The primary objective of this open label extension study is to evaluate the long-term safety and tolerability of maralixibat.

NCT ID: NCT04168385 Active, not recruiting - Clinical trials for Cholestatic Liver Disease

MRX-800: A Long-Term Safety Study of Maralixibat in the Treatment of Cholestatic Liver Disease in Subjects Who Previously Participated in a Maralixibat Study

MERGE
Start date: January 16, 2020
Phase: Phase 2
Study type: Interventional

Evaluate the long-term safety of maralixibat (MRX) in subjects with cholestatic liver disease including, but not limited to, Alagille Syndrome (ALGS), Progressive Familial Intrahepatic Cholestasis (PFIC) and Biliary Atresia.

NCT ID: NCT03997994 Active, not recruiting - Biliary Stricture Clinical Trials

DIGEST I Drug Coated Balloon for Biliary Stricture

DIGEST
Start date: May 12, 2019
Phase: N/A
Study type: Interventional

DIGEST I Pilot study is a feasibility study for evaluating the safety and efficacy of DCBs.

NCT ID: NCT03659916 Active, not recruiting - Clinical trials for Progressive Familial Intrahepatic Cholestasis

Long Term Safety & Efficacy Study Evaluating The Effect of A4250 in Children With PFIC

Start date: September 28, 2018
Phase: Phase 3
Study type: Interventional

Open Label Extension Study to evaluate long term safety and persistence of effect of A4250 in children with PFIC.

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.