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Hepatitis clinical trials

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NCT ID: NCT01070550 Completed - Clinical trials for Hepatitis C, Chronic

PROPHESYS 1: An Observational Study on Predictors of Response in Treatment-naïve Patients With Chronic Hepatitis C Treated With Pegasys (Peginterferon Alfa-2a)

Start date: June 2007
Phase: N/A
Study type: Observational

This observational study will assess predictors of early on-treatment and sustained virological response in treatment-naïve patients with chronic hepatitis C initiated on treatment with Pegasys (peginterferon alfa-2a) and ribavirin. Data will be collected during the treatment period (24 or 48 weeks) and 12 and 24 weeks after the end of treatment. Target sample size is <5000.

NCT ID: NCT01070407 Completed - Hepatitis C Clinical Trials

A Study of a New Candidate Vaccine Against Hepatitis C Virus (HCV)

Start date: July 2007
Phase: Phase 1
Study type: Interventional

HCV001 is a Phase I study to ascertain the safety and immunogenicity of a novel vaccine against Hepatitis C virus (HCV). The vaccine is based on the sequential delivery, by intramuscular route, of two different adenoviral vectors, of human and chimpanzee origin respectively, bearing the same genetic information for HCV antigens (NS region). The two recombinant vectors, called Ad6NSmut and AdCh3NSmut, are weakened and unable to multiply within the body; they are designed to induce an immune response against HCV proteins. Although Ad6NSmut and AdCh3NSmut have never been given to humans before this trial, promising results have been obtained in non-human studies. The HCV001 study is designed to explore different prime-boost regimes concerning dose, order and interval of administration of Ad6NSmut and AdCh3NSmut.

NCT ID: NCT01068444 Completed - Hepatitis Clinical Trials

The Efficacy and Safety of Pioglitazone in Patients With Nonalcoholic Steatohepatitis

Start date: April 2009
Phase: Phase 2
Study type: Interventional

Recent studies have demonstrated that PPARγ as well as diet control could improve glycemic control, decrease serum ALT level, decrease hepatic fat distribution, and increase intrahepatic insulin sensitivity. The purposes of this study are: 1. Primary aims: 1. Comparison between Pioglitazone and placebo groups in terms of steatosis and liver function tests. 2. Evaluation of clinical safety of Pioglitazone 2. Secondary aims: 1. Comparison between Pioglitazone and placebo groups in terms of liver necroinflammation and fibrosis. 2. The impact of Pioglitazone on the related metabolic index, including insulin resistance(HOMA-IR), newly-onset diabetes, metabolic syndrome, lipid profiles (T-Chol, HDL-C, LDL-C, TG). 3. Comparison between Pioglitazone and placebo groups in terms of high-sensitive C-reactive protein changes. 3. Interventional aim: Assessment the association between magnetic resonance imaging study and intrahepatic fat distribution before and after Pioglitazone treatment.

NCT ID: NCT01066819 Completed - Clinical trials for Hepatitis C, Chronic

PROPHESYS 3: Observational Study on Predictors of Response in Patients With Treatment-naïve Chronic Hepatitis C Initiated on Treatment With Pegasys (Peginterferon Alfa-2a) or Peginterferon-alfa-2b

Start date: January 2008
Phase: N/A
Study type: Observational

This observational study will assess predictors of early on-treatment and sustained virological response in treatment-naïve patients with chronic hepatitis C initiated on treatment with Pegasys (peginterferon alfa-2a) or peginterferon alfa-2b and ribavirin. Data will be collected during the treatment period (24 or 48 weeks) and 12 and 24 weeks after the end of treatment. Target sample size is <2000.

NCT ID: NCT01066793 Completed - Clinical trials for Hepatitis C, Chronic

PROPHESYS 2: An Observational Study on Predictors of Response in Treatment-naïve Patients With Chronic Hepatitis C Treated With Pegasys (Peginterferon Alfa-2a) or Peginterferon-alfa-2b

Start date: October 2007
Phase: N/A
Study type: Observational

This observational study will assess predictors of early on-treatment and sustained virological response in treatment-naïve patients with chronic hepatitis C initiated on treatment with Pegasys (peginterferon alfa-2a) or peginterferon alfa-2b and ribavirin. Data will be collected during the treatment period (24 or 48 weeks) and 12 and 24 weeks after the end of treatment. Target sample size is <2000.

NCT ID: NCT01063036 Completed - Chronic Hepatitis B Clinical Trials

Efficacy and Safety Study of Entecavir Plus Tenofovir in Patients With Chronic Hepatitis B Who Failed Previous Treatment

Start date: May 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to show that the combination of entecavir and tenofovir, is effective and well tolerated in chronic hepatitis B patients who have failed previous treatment.

NCT ID: NCT01062321 Completed - Pregnancy Clinical Trials

Role of Cytokines in Hepatitis E Virus Infection During Pregnancy

Start date: August 2009
Phase: N/A
Study type: Observational

Hepatitis E virus is a public health problem in several countries of the world where safe drinking water is a problem. HEV is an exclusive cause of epidemic hepatitis in general population. HEV infection occurs most frequently in rainy season. The disease affects mainly young adults in the age of 15-40 years.HEV viral infection is of particular concern in pregnancy. It is a potential disaster for mother and child. HEV infection during pregnancy is fulminant and fatal especially if it occurs in third trimester. The mortality in the second trimester is around 20% and reaches upto 45% in the third trimester.

NCT ID: NCT01058512 Completed - Hepatitis C Clinical Trials

A Trial of NOV-205 in Hepatitis C Patients Who Failed Standard Therapy

NOV-205
Start date: March 2010
Phase: Phase 2
Study type: Interventional

The purpose of this research study is to find out the effect of the investigational drug NOV-205 on the level of hepatitis C virus in the blood and whether NOV-205 is well-tolerated at different doses when taken by subjects with hepatitis C.

NCT ID: NCT01057667 Completed - Clinical trials for Hepatitis C, Chronic

A Study of RO5024048 in Combination With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) in Patients With Chronic Hepatitis C Genotype 1 or 4

Start date: February 2010
Phase: Phase 2
Study type: Interventional

This equally randomized (1:1), double-blind, parallel arm study will assess the safety and antiviral efficacy of RO5024048 added to standard Pegasys (peginterferon alfa-2a) plus Copegus (ribavirin) therapy in patients with chronic hepatitis C genotype 1 or 4. Patients in arm A will receive RO5024048 (1000mg orally twice daily) for 24 weeks in addition to Pegasys (180 micrograms sc weekly) and Copegus (1000mg or 1200mg orally daily). Patients achieving a rapid virological response (RVR) at week 4, sustained through week 22, will stop all treatment at week 24; non-RVR patients will continue treatment with Pegasys and Copegus for another 24 weeks up to week 48. Patients in arm B will receive standard treatment with Pegasys (180 micrograms sc weekly) and Copegus (1000mg or 1200mg orally daily) for 48 weeks. Anticipated time on study treatment is up to 48 weeks. Target sample size is <200.

NCT ID: NCT01055821 Completed - Clinical trials for Chronic Hepatitis C Infection

Efficacy of the Therapeutic Vaccine TG4040 Combined With Pegylated Interferon and Ribavirin in Chronic HCV Patients

HCVac
Start date: May 2010
Phase: Phase 2
Study type: Interventional

The primary objective of this protocol is to study the effect of the standard of care in hepatitis C (pegylated interferon and ribavirin) associated with therapeutic vaccine TG4040 on the viral load of treatment-naïve patients with chronic genotype 1 hepatitis C infection.