This is a multi-center, open-enrollment, retrospective, non-interventional epidemiologic
study without any clinical treatment. Its primary objective is to understand 1) incidence of
drug-induced liver injury, including incidences among all the hospitalized patient, among
patients in department of hepatic diseases, digestive diseases, oncology, hematology etc.,
individually; 2) epidemiologic characteristics of drug-induced liver injury, including
suspected ... Read More
Antiviral resistance mutations limit the efficacy of therapy for chronic hepatitis B. At
year 2, resistance to adefovir may occur as high as 25% in patients with history of
lamivudine resistance. Resistance to entecavir is reported to be 10% in lamivudine
refractory patients during the same period. However, combination of lamivudine and adefovir
decreased the adefovir resistance rate as low as 0% in the recent studies. By overcoming the
antiviral resistance, ... Read More
This is a randomized, double-blind, multicenter, placebo-controlled (standard therapy +
placebo), phase 2 efficacy and safety study of the Tolvaptan tablets in treatment of
patients with non-hypovolemic non-acute hyponatremia arising from a variety of etiologies.
240 (120 in each group) patients are to be enrolled randomly into Tolvaptan group or placebo
group. Subjects in Tolvaptan group will receive standard therapy + Tolvaptan (15-60mg/day),
while those ... Read More
Description: The Manhattan HIV/Hepatology Brain Bank (MHBB) was established in 1998 as a
resource for the AIDS research community. The MHBB was created to act as a center for the
provision of pre- and post-mortem tissues and body fluids from HIV infected persons. It has
recently expanded its goals to assist in the elucidation of liver disease-induced nervous
The MHBB is dedicated to improving the understanding of HIV and Hepatitis C and ... Read More
The current pilot study assesses the use of magnetic resonance imaging (MRI) to quantify
hepatic steatosis. It will provide preliminary data regarding the use of omega-3 fatty acid
supplementation (Lovaza) for the treatment of nonalcoholic steatohepatitis (NASH).
Source: Valeant Pharmaceuticals International, Inc.
The purpose of the study is to evaluate if Rifaximin alone or Rifaximin plus Lactulose
delays the onset of hepatic encephalopathy (HE) in cirrhotic subjects who have had a
previous episode of HE.
Source: Postgraduate Institute of Medical Education and Research
Minimal hepatic encephalopathy (MHE) has a negative effect on patients’ daily functioning.
No study has so far investigated the effect of treatment related improvement in cognitive
functions on health related quality-of-life (HRQOL). This study was carried out to determine
the influence of treatment on psychomotor performance and on HRQOL in patients with MHE.
The mean number of abnormal NP tests decreased significantly in patients in treated group
compared ... Read More
The purpose of this study is to assess the safety, tolerability, and efficacy of sofosbuvir
(GS-7977; PSI-7977) administered in combination with pegylated interferon and ribavirin
(PEG/RBV) in treatment-naive patients with HCV genotypes 1,4,5,6, or indeterminate genotype.
Source: University of Medicine and Pharmacy Craiova
The main objective is the assessment of MRI (Magnetic Resonance Imaging) Spectroscopy in
patients diagnosed with hepatic steatosis in treatment with combination Silimarin,
Phyllanthus Niruri and Choline.
- NAFLD (Non-alcoholic fatty liver disease) has become the most common cause of liver
disease in Western countries (hepatic manifestation of insulin resistance);
- NAFLD represents a cardiovascular risk factor;
- Lifestyle modification(weight loss)is the effective medical treatment recommended for
NASH (Non-alcoholic Steatohepatitis);
- Ezetimibe could represent a novel safe treatment for NAFLD (Patel 2006. Here the
... Read More
The purpose of the study is to validate the diagnostic accuracy and reproducibility of SAPI
to predict significant hepatic fibrosis in HCV patients with PNALT who are scheduled to
receive combination therapy with pegylated interferon plus ribavirin and percutaneous liver
Portal hypertension (PHT) that leads to esophageal varices is clinically present, at the
time of diagnosis, in 60% of cirrhotic patients (Groszmann NEJM 2005). Variceal bleeding is
a life-threatening complication. The yearly incidence of the first variceal bleeding in
cirrhotic patients is estimated to 4%. This risk increases to 15% when medium or large
varices are initially present, (D'amico Baillieres Clin Gastroenterol 1997); Therefore, for
patient with ... Read More
The purpose of this early access protocol is to provide access to adefovir dipivoxil prior
to its commercial availability to people with lamivudine-resistant chronic hepatitis B who
have limited treatment options.
To investigate the safety and performance of the Automated Fluid Shunt in patients with
ascites and diuretic resistance.
Study Size and Duration The primary study population will include 40 patients enrolled and
implanted with the NovaShunt Automated Fluid Shunt (AFS) in up to 15 centers in Europe.
An Investigator-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Establish
Therapeutic Equivalence of 1000 mg Mesalamine Rectal Suppositories and Canasa® Rectal
Suppositories (1000 mg Mesalamine, USP) in the Treatment of Mild to Moderate Ulcerative
Proctitis will be conducted in 533 patient with a estimated duration of 18months.
Source: University of Texas Southwestern Medical Center
This Phase 2a clinical study is designed to provide data on OCR-002 in patients with acute
liver failure/acute liver injury (ALF/ALI) in regard to:
- safety and tolerability;
- metabolism of the compound to glutamine and phenylacetylglutamine (PAGN);
- its effect on circulating ammonia levels and neurological function in patients with and
without impaired renal function after continuous infusion at different infusion rates.
Subjects ... Read More