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Fibrosis clinical trials

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NCT ID: NCT02975726 Completed - Liver Cirrhosis Clinical Trials

Peritoneal Dialysis Catheters for the Treatment of Refractory Ascites

Start date: January 2017
Phase: N/A
Study type: Interventional

One complication of liver disease is the buildup of fluid within the belly. This is known as ascites. Patients who have ascites have a decreased appetite, pain, nausea and shortness of breath. Ascites is typically treated with medications, however when that does not work, patients need a procedure where a needle is inserted in the belly every few weeks to drain the excess fluid. About 2 in 5 patients with ascites from liver failure can get kidney disease from their worsening liver function or from the drainage of fluid with needles. Once patients have both advanced liver disease and kidney disease, their chance of dying largely increases. The present study will be the first of its kind to study a new technique to treat ascites. Investigators are planning to place a tube in a patient's belly to drain the excessive amounts of fluid. This technique is similar to how one type of dialysis is done to treat patients with kidney failure. This study is set as a pilot investigation in order to determine the feasibility of doing a larger, randomized clinical trial investigating the use of this novel technique. Importantly, advanced liver disease patients are at high risk to develop kidney disease, and therefore are an important group to focus on. Investigators believe that this technique will prevent or slow the development of kidney disease in liver failure patients, and improve their quality of life, far more than the current available treatments.

NCT ID: NCT02973503 Completed - Clinical trials for Chronic HCV Infection

Study to Investigate the Efficacy of Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in Treatment-Naïve, HCV GT1b-Infected Patients, With Non-severe Fibrosis

STREAGER
Start date: January 11, 2017
Phase: Phase 3
Study type: Interventional

A Phase 3, Global, Multicenter, Open-Label Study to Investigate the Efficacy of Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in Treatment-Naïve, HCV GT1b-Infected Patients, with non-severe fibrosis The primary objectives of this study are as follows: - To evaluate the efficacy of Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in Treatment-Naïve, HCV GT1b-Infected Patients, with non- severe fibrosis as measured by the proportion of subjects with sustained viral response 12 weeks after cessation of treatment (SVR 12). - To evaluate the safety and tolerability of EBV/GZR treatment The secondary objectives of this study are as follows: - To determine the proportion of subjects who attain SVR at 4 and 24 weeks after cessation of treatment (SVR4 and SVR24) - To evaluate the proportion of subjects with virologic failure - To evaluate the kinetics of circulating HCV RNA during treatment and after cessation of treatment. - To evaluate the emergence of viral resistance to EBV/GZR during treatment and after cessation of treatment

NCT ID: NCT02960204 Completed - Cirrhosis Clinical Trials

Emricasan, an Oral Caspase Inhibitor, in Subjects With NASH Cirrhosis and Severe Portal Hypertension

ENCORE-PH
Start date: October 17, 2016
Phase: Phase 2
Study type: Interventional

This is a multicenter, randomized, double-blind, placebo-controlled trial involving subjects with NASH cirrhosis and severe portal hypertension (defined as HVPG ≥12 mmHg as determined by the central reader assigned to this study). Upon successful screening, subjects will be randomized to receive either emricasan 50 mg BID, 25 mg BID, or 5 mg BID or matching placebo BID.

NCT ID: NCT02958592 Completed - Liver Tumor Clinical Trials

Assessment of Hepatic Fibrosis by Shear Wave Elastography in Patients With Liver Malignancy: A Prospective Single-center Study

Start date: June 2015
Phase: N/A
Study type: Observational

To evaluate the diagnostic performance of two-dimensional shear-wave elastography (SWE) for staging hepatic fibrosis in the background liver parenchyma in patients with liver tumors before hepatic resection, using resected tissue pathology as a reference standard.

NCT ID: NCT02958345 Completed - Herpes Zoster Clinical Trials

Placebo Controlled Evaluation of the Cell Mediated Immune Response of Cirrhotic Subjects to Zostavax™

Start date: June 2013
Phase: Phase 4
Study type: Interventional

Study Design: Double-blinded, placebo controlled study of the efficacy of Zostavax in cirrhosis. Subjects will receive either Zostavax or placebo and will be followed for four months. Hypothesis: The investigators hypothesize Zostavax would induce cell-based immunity in cirrhotic patients like that seen in elderly patients.

NCT ID: NCT02953314 Completed - Cystic Fibrosis Clinical Trials

A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of VX-661/Ivacaftor in Pediatric Subjects With Cystic Fibrosis (CF)

Start date: November 2016
Phase: Phase 3
Study type: Interventional

This is a Phase 3, 2-part (Part A and Part B), open label, multicenter study evaluating the pharmacokinetic (PK), safety, and tolerability of multiple doses of tezacaftor (TEZ) in combination with ivacaftor (IVA) in subjects 6 through 11 years of age with CF who are homozygous or heterozygous for the F508del- CF transmembrane conductance regulator protein (CFTR) mutation.

NCT ID: NCT02951429 Completed - Clinical trials for Idiopathic Pulmonary Fibrosis

Efficacy, Safety, and Tolerability Study of Pirfenidone in Combination With Sildenafil in Participants With Advanced Idiopathic Pulmonary Fibrosis (IPF) and Intermediate or High Probability of Group 3 Pulmonary Hypertension

Start date: December 31, 2016
Phase: Phase 2
Study type: Interventional

This Phase IIb, randomized, placebo-controlled, multicenter, international study will evaluate the efficacy, safety, and tolerability of sildenafil or placebo added to pirfenidone (Esbriet) treatment in participants with advanced IPF and intermediate or high probability of Group 3 pulmonary hypertension (PH) who are on a stable dose of pirfenidone with demonstrated tolerability. Participants will be randomized to receive 1 year of treatment with either oral sildenafil or matching placebo while continuing to take pirfenidone.

NCT ID: NCT02951195 Completed - Cystic Fibrosis Clinical Trials

A Study Evaluating the Safety of VX-152 Combination Therapy in Adults With Cystic Fibrosis

Start date: November 2016
Phase: Phase 2
Study type: Interventional

This is a Phase 2, randomized, double blind, placebo and active-controlled, parallel group, multicenter study designed to evaluate the safety and tolerability of VX-152 in Triple Combination (TC) with tezacaftor (TEZ; VX-661) and ivacaftor (IVA; VX-770) in subjects with cystic fibrosis (CF) who are heterozygous for the F508del mutation and a minimal function (MF) CFTR mutation not likely to respond to TEZ and/or IVA therapy (F508del/MF), or who are homozygous for the F508del mutation of the CF transmembrane conductance regulator (CFTR) gene (F508del/F508del).

NCT ID: NCT02951182 Completed - Cystic Fibrosis Clinical Trials

A Study Evaluating the Safety and Efficacy of VX-440 Combination Therapy in Subjects With Cystic Fibrosis

Start date: October 2016
Phase: Phase 2
Study type: Interventional

This is a Phase 2, randomized, double-blind, placebo- and active-controlled, parallel group, multicenter study to evaluate the safety, tolerability, and efficacy of VX-440 in dual and triple combination with tezacaftor (TEZ; VX-661) and ivacaftor (IVA; VX-770) in subjects with cystic fibrosis (CF) who are homozygous for the F508del mutation of the CF transmembrane conductance regulator (CFTR) gene (F508del/F508del), or who are heterozygous for the F508del mutation and a minimal function (MF) CFTR mutation not likely to respond to TEZ and/or IVA therapy (F508del/MF).

NCT ID: NCT02950883 Completed - Cystic Fibrosis Clinical Trials

Saline Hypertonic in Preschoolers + CT

SHIP-CT
Start date: March 24, 2015
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to assess whether inhalation of 7% hypertonic saline (HS) twice daily for 48 weeks reduces structural lung disease as assessed by computed tomography (CT) in comparison with inhalation of 0.9% isotonic saline (IS) in preschool children (ages 3 to 6) with cystic fibrosis.