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Hepatitis, Chronic clinical trials

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NCT ID: NCT01095835 Completed - Clinical trials for Hepatitis B, Chronic

A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With HBeAg-Negative Chronic Hepatitis B Virus (HBV)

Start date: February 2005
Phase: Phase 3
Study type: Interventional

This study will compare the efficacy and safety of 2 different durations of treatment with PEGASYS, in patients with HBeAg-negative chronic HBV. It will also compare PEGASYS treatment alone and in combination with lamivudine. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.

NCT ID: NCT01090232 Completed - Clinical trials for Kidney-transplant Recipients With Chronic Hepatitis E Virus Infection

Host Responses in Kidney-transplant Recipients With Chronic Hepatitis E Virus Infection

Start date: February 2010
Phase: N/A
Study type: Interventional

Hepatitis E is a worldwide disease. It is the leading or second leading cause of acute hepatitis in adults in developing countries from sub-Saharan Africa or Southeast Asia, where it is hyperendemic and principally water-borne. In industrialised western countries, hepatitis E was until recently considered as imported from hyperendemic geographical areas, but is currently an emerging autochthonous infectious disease. A growing body of data from Europe, America, Australia, and Asia strongly indicate that pigs represent a major Hepatitis E Virus (HEV) reservoir and might be a source of zoonotic transmission to humans through direct or indirect exposure. Hepatitis E typically causes self-limited acute infection. However, the overall death rate is 1-4%, and it can reach 20% in pregnant women and might be still higher in patients with underlying chronic liver disease. To date, no preventive or curative treatment of hepatitis E is available.

NCT ID: NCT01088009 Completed - Clinical trials for Compensated Chronic Hepatitis B

Efficacy Optimizing Research of Lamivudine Therapy

EXPLORE
Start date: March 2010
Phase: Phase 4
Study type: Interventional

The purpose of this study is to compare the adefovir early add-on to rescue therapy strategy, and also explore the efficacy of Lamivudine and adefovir de-novo combination therapy.

NCT ID: NCT01079806 Completed - Clinical trials for Chronic Hepatitis B Virus, Pediatric

A Phase III Study of the Safety and Efficacy of Entecavir in Pediatric Patients With Chronic Hepatitis B Virus Infection

Start date: June 30, 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study was to evaluate the safety and efficacy of entecavir in pediatric patients with chronic hepatitis B virus infection

NCT ID: NCT01074008 Completed - Hepatitis C Clinical Trials

A Randomized Study to Evaluate the Safety, Tolerability and Antiviral Activity of ABT-450, ABT-333 and ABT-072

Champion2
Start date: March 2010
Phase: Phase 2
Study type: Interventional

This study assessed the safety, tolerability, pharmacokinetics, and antiviral activity of multiple oral doses of ABT-450/ritonavir (r), ABT-333 (also known as dasabuvir), or ABT-072 in hepatitis C virus (HCV), genotype 1-infected, treatment-naïve adults.

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: 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.

NCT ID: NCT01054742 Completed - Hepatitis C Clinical Trials

Observational Study of Patients With Chronic Hepatitis C Virus (HCV) Infected With HCV Genotype 1 Low Virus Load (LVL 1) and Effect of PegIntron Plus Rebetol Treatment (Study P04793 Part 2)

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

The purpose of this observational study was to provide summary data from participants who relapsed at the end of the follow-up phase after 24 weeks of treatment with standard care PegIntron plus ribavirin in Part 1 of the study (NCT00709228) and who then received retreatment during Part 2 of the study. Relapse was defined as having a positive virology result at the Week 24 post-treatment follow-up, after a negative result at the Week 24 end-of-treatment time point. Hepatitis C Virus Ribonucleic Acid (HCV-RNA) levels were measured at Day 1 and Weeks 12, 24, and 48 of the extension, and at Follow-up Week 24.

NCT ID: NCT01037166 Completed - Chronic Hepatitis B Clinical Trials

Study in Japan of the Safety And Antiviral Activity in Adults With Chronic Hepatitis B Current Lamivudine Therapy

Start date: December 2002
Phase: Phase 2
Study type: Interventional

The objectives are to demonstrate that entecavir has antiviral activity undetectable HBV DNA measured, the Roche AmplicorTM PCR at Week 48, and to assess the safety and the pharmacokinetic of entecavir in Japanese patients with hepatitis B who have an incomplete response to current lamivudine therapy