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THE EFFECTS OF RECOMBINANT HUMAN INSULIN-LIKE GROWTH FACTOR-1 ON THE NUTRITIONAL STATUS IN PATIENTS WITH LIVER CIRRHOSIS: A PILOT STUDY.

The primary objective of this pilot study is to evaluate the effects of 6 months of recombinant human IGF-I (rhIGF-I) treatment on the body composition.The secondary objective is to assess the effects of the treatment on the liver function,…

Acute biliary Pancreatits: early ERC plus sphincterotomy versus Conservative treatment: the APEC trial, a randomized, superiority, assessor-blinded multicenter trial.

The objective of the study is to investigate whether early ERC plus ES in patients with suspected APB and a predicted severe disease course without cholangitis, lowers the incidence of a composite endpoint of mortality and severe morbidity. Major…

A Long Term Follow-up Registry for Subjects Who Achieve a Sustained Virologic Response to Treatment in Gilead-Sponsored Trials in Subjects with Chronic Hepatitis C Infection

The primary objective of this Registry is:• To assess the durability of sustained virologic response (SVR) following treatment in a Gilead-sponsored hepatitis C study.The secondary objectives of this Registry are:• To determine whether subsequent…

Evaluation of the CAP-value for quantitating liver steatosis using 1H-MRS and liver biopsy as reference standard

Main objective: investigate the correlation between CAP-values with fat percentages found at 1H-MR Spectroscopy and steatosis grade at liver biopsy. Secondary objectives: investigate the reproducibility of CAP-measurements; investigate the…

A Long Term Follow-up Registry Study of Subjects Who Did Not Achieve Sustained Virologic Response in Gilead-Sponsored Trials in Subjects with Chronic Hepatitis C Infection

The primary objective of this Registry is:• To evaluate HCV viral sequences and the persistence or evolution of treatment emergent viral mutations in subjects who fail to achieve an SVR after treatment with a Gilead oral antiviral containing regimen…

FunctiOnal lIver MicrocIrculation measured by SorbiTol and Indocyaninegreen plasma Clearance, the OptIMISTIC- study.

Objectives: The objective of the study is to observe the sorbitol clearance and compare this to ICG clearance in different circumstances of normal and compromised liver blood flow.

A Phase III, Randomised, Partially Double-Blind and Placebo-Controlled Study of BI 207127 in Combination with Faldaprevir and Ribavirin in Treatment-Naïve Patients with Chronic Genotype 1 HCV Infection

The aim of the study is to confirm efficacy and safety of treatment with 600 mg of BID BI207127 in combination with 120 mg QD Faldaprevir and RBV for 16 and 24 weeks in target chronically infected HCV GT1b treatment naïve patients, including a…

Treatment adherence in patients treated with telaprevir for a chronic hepatitis C genotype 1 infection: an observational study

Primary objective To establish the mean level of adherence to telaprevir in chronic hepatitis C patients during treatment with telaprevir, pegylated-interferon-alfa and ribavirin.Secondary objectives• To establish the mean level of adherence to…

A randomised, controlled clinical trial assessing the efficacy of;Lanreotide to halt disease progression in ADPKD

First, to demonstrate whether Lanreotide attenuates progression of the renal phenotype in ADPKD patients as measured by change in rate of renal function decline and change in renal volume. Second, to demonstrate whether Lanreotide modifies…

An Open-Label Study of GS-7977+ Ribavirin with or without Peginterferon Alfa-2a in Subjects with Chronic HCV Infection who Participated in Prior Gilead HCV Studies

The primary objectives of this study are:* To determine the efficacy of GS-7977 + RBV with or without Peginterferon alfa-2a (PEG) as measured by the proportion of subjects with sustained viral response at 12 weeks after discontinuation of therapy (…

Hepatic histology of IBD patients following one year of combination therapy with allopurinol and low-dose conventional thiopurines

To determine the percentage of patients with nodular regenerative hyperplasia of the liver after at least 1 year of combination therapy of allopurinol and low dose AZA or MP and to compare this with the reported findings of 6TG induced NRH

Non-invasive quantification of liver fibrosis with ultrasound: pilot

Main goal: In this non-invasive pilot study, we want to investigate whether these techniques can discriminate between healthy livers and livers with cirrhosis. For the new techniques to be applied as an alternative for biopsy, the output values of…

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co-administered with Ribavirin (RBV) in
Treatment-Experienced Adults with Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (SAPPHIRE-II)

The primary objectives of this study are to compare the percentage of subjects achieving SVR12 (HCV RNA < lower limit of quantification [LLOQ] 12 weeks following treatment) of 12 weeks of treatment with ABT-450/r/ABT-267 and ABT-333 co-…

Effects of DDAVP (1-deamino-8-D arginine vasopressin) infusion on parameters of hemostasis in patients with liver cirrhosis

This study aims to collect biochemical evidence for the pro-hemostatic capacity of DDAVP in patients with cirrhosis, in order to proceed towards a more rational clinical use of this drug.

CEFTRIAXONE NEONATAL THERAPY (CEFSINT) : A RANDOMIZED CONTROLLED TRIAL TO EVALUATE THE EFFECT OF CEFTRIAXONE ON HYPERBILIRUBINEMIA

To compare in a randomized controlled trail (RCT) the risk of neonatal hyperbilirubinaemia between neonates treated with CFT and amoxicillin-clavulanic acid (augmentin, AUGM) combination versus neonates treated with the aminoglycoside, tobramycin (…

A randomized double blind placebo controlled study on the effects of fenretinide Lym-X-Sorb on insulin sensitivity in obese insulin resistant subjects

Primary objective:To assess the effects of fenretinide on hepatic and peripheral insulin sensitivity in obese, insulin resistant subjectsSecondary objective:To assess the effects of fenretinide on hepatic steatosis, body weight and body fat…

A Phase 3, Randomized, Single-Blind, Controlled Trial of Topical Fibrocaps* in Intraoperative Surgical Haemostasis

Primary:The primary objective of the study is to demonstrate the superiority of Fibrocaps plus gelatin sponge, as compared to gelatin sponge alone, for achieving hemostasis in subjects undergoing spine, liver, vascular or soft tissue surgery, when…

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GS-7977 + Ribavirin for 12 Weeks in Treatment Naïve and
Treatment Experienced Subjects with Chronic Genotype 2 or 3 HCV Infection.

The primary objectives of this study are as follows:• To determine the efficacy of treatment with GS-7977+ribavirin (RBV) compared as measured by the proportion of subjects with sustained viral response 12 weeks after discontinuation of therapy (…

An Open-Label Study to Evaluate the Safety, Antiviral Activity and Pharmacokinetics of Direct-Acting Antiviral Agent (DAA) Treatment in Combination with Peginterferon *-2a and Ribavirin (pegIFN/RBV) in Chronic Hepatitis C Virus (HCV) Infected Subjects Who Have Experienced Virologic Failure in a Previous AbbVie or Abbott DAA Combination Study

The primary objective of this study is to evaluate the safety and antiviral efficacy, defined as the percentage of subjects with sustained virologic response 12 weeks post-dosing (SVR12; HCV RNA < LLOQ 12 weeks after the last dose of study…

An Open-Label Re-treatment Study with Peg-Interferon Alfa-2a, Ribavirin and BMS-790052 With or Without BMS-650032 for Subjects With Chronic Hepatitis C

Primary ObjectiveTo assess the efficacy based on the proportion of subjects with SVR12, defined as HCV RNAgenotype 1 who are prior non-responders to pegIFNα-2a/RBV.Secondary Objectives• To assess efficacy, as determined by the proportion of subjects…