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Hepatitis clinical trials

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NCT ID: NCT00442572 Completed - Clinical trials for Hepatitis B, Chronic

SOFIA-LTT Study: A Study of Intermittent Long Term Treatment With PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With HBeAg Negative Chronic Hepatitis B (CHB).

Start date: July 2006
Phase: Phase 2
Study type: Interventional

This 2 arm study will evaluate the efficacy and safety of intermittent treatment with PEGASYS in HBeAg negative patients with chronic hepatitis B who have demonstrated virological and biochemical response after treatment with interferon alfa. After 48 weeks therapy with interferon alfa, and 24 weeks treatment-free follow-up, eligible patients will be randomized into the PEGASYS or the observational group. Those in the PEGASYS group will receive 4 therapeutic cycles of long term intermittent treatment with PEGASYS (135 micrograms sc weekly for 12 weeks, followed by a treatment-free period of 12 weeks) and those in the observational arm will receive no specific antiviral treatment. The anticipated time on study treatment is 1-2 years, and the target sample size is 100 individuals.

NCT ID: NCT00441974 Completed - Chronic Hepatitis B Clinical Trials

Adefovir Dipivoxil For The Treatment Of Chinese Compensated Chronic Hepatitis B(CHB)Patients

Start date: December 2006
Phase: Phase 4
Study type: Interventional

This 48-week open-label study of local manufactured adefovir dipivoxil Tablet evaluates the efficacy and safety of adefovir 10mg once daily in Chinese subjects with compensated CHB. Primary endpoint is proportion of subjects achieving HBV DNA undetectable (<=1000 copies/mL by by Roche COBAS AMPLICOR HBV MONITOR Test) at week 48. Approximately 1250 patients will be recruited in 30 study centers in China. The subjects are offered 48 weeks of open label adefovir dipivoxil treatment, with assessments every three months, after with is a 12-week post study treatment follow-up prior to study completion.

NCT ID: NCT00441493 Completed - Hepatitis C Clinical Trials

Fluvastatin Versus Hepatitis C Virus

Start date: September 2006
Phase: N/A
Study type: Interventional

This is a dose finding and efficacy trial for fluvastatin versus hepatitis C.

NCT ID: NCT00441012 Completed - Hepatitis B Clinical Trials

Study of Modified Process Hib/Hep B Vaccine in Infants (V121-019)(COMPLETED)

Start date: December 2006
Phase: Phase 3
Study type: Interventional

To determine if there is an improvement in the immune response to HBsAg (hepatitis B virus) in healthy infants using a modified process in a combination Haemophilus Influenzae, type b/Hepatitis B vaccine and a currently licensed Haemophilus Influenzae, type b/Hepatitis B vaccine

NCT ID: NCT00440531 Completed - Hepatitis B Clinical Trials

Study of Recombinant Modified Process Hepatitis B Vaccine in Older Adults (V232-059)(COMPLETED)

Start date: November 2006
Phase: Phase 3
Study type: Interventional

The purpose of this trial is to determine if there is an improvement in the immune response of older adults over 50 years of age using a modified process hepatitis B vaccine and a currently licensed hepatitis B vaccine (RECOMBIVAX HB™).

NCT ID: NCT00440297 Completed - Clinical trials for Hepatitis B Virus Infection

Hepatitis B Vaccine Predialysis/Dialysis Study (V232-060)

Start date: December 2006
Phase: Phase 3
Study type: Interventional

To describe the immunogenicity and safety of modified process hepatitis B vaccine administered to renal predialysis and dialysis patients

NCT ID: NCT00436163 Completed - Clinical trials for Hepatitis B, Chronic

A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With HBeAg-Positive Chronic Hepatitis B (CHB).

Start date: March 2007
Phase: Phase 4
Study type: Interventional

This single arm study will evaluate the efficacy and safety of PEGASYS in treatment-naive Baltic patients with HBeAg-positive chronic HBV. All patients will receive PEGASYS 180 micrograms s.c. once weekly. Following 48 weeks of treatment, there will be a 24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

NCT ID: NCT00435825 Completed - Clinical trials for Hepatitis B, Chronic

A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Hepatitis Be Antigen (HBeAg) Positive Chronic Hepatitis B (CHB).

Start date: March 2007
Phase: Phase 4
Study type: Interventional

This 4 arm study will compare the efficacy and safety of PEGASYS given for 24 or 48 weeks, and at doses of 90 or 180 micrograms weekly, in the treatment of HBeAg positive patients with chronic hepatitis B. Patients will be randomized to one of 4 treatment groups: a)PEGASYS 90 micrograms subcutaneous (sc) weekly for 24 weeks, b)PEGASYS 180 micrograms sc weekly for 24 weeks, c)PEGASYS 90 micrograms sc weekly for 48 weeks or d)PEGASYS 180 micrograms sc weekly for 48 weeks. Following treatment there will be a 24 week period of treatment-free follow-up in all treatment groups for the primary endpoint. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

NCT ID: NCT00435812 Completed - Hepatitis B Clinical Trials

Safety and Efficacy of HEPLISAV™ Hepatitis B Virus Vaccine Compared With Engerix-B® Vaccine

Start date: December 2006
Phase: Phase 3
Study type: Interventional

The purpose of this study is to find out if a new investigational hepatitis B virus vaccine, HEPLISAV™, is safe and effective compared with Engerix-B® vaccine in subjects 11-55 years old. The primary hypothesis is that the seroprotective immune response of HEPLISAV™ is at least as good as that of Engerix-B®.

NCT ID: NCT00433108 Completed - Chronic Hepatitis C Clinical Trials

Trial of MitoQ for Raised Liver Enzymes Due to Hepatitis C

Start date: March 2007
Phase: Phase 2
Study type: Interventional

A Phase 2, randomized, double-blind, parallel design trial of two doses of mitoquinone mesylate (MitoQ) and of placebo in patients with chronic Hepatitis C. MitoQ is a mitochondria-targeted antioxidant that rapidly permeates the lipid bilayer and accumulates within mitochondria in organs such as liver, brain, heart, skeletal muscle. There is strong evidence for increased oxidative stress and mitochondrial damage leading to apoptosis via caspase activation. Several studies have shown that MitoQ protects cells from apoptosis by acting as a caspase inhibitor and may be effective in reducing cell damage in liver disease. It is hypothesised that administration of MitoQ will lower raised ALT seen in patients with chronic Hepatitis C compared with placebo. Approximately 36 patients who have been unresponsive or not suitable for interferon-based therapy will be enrolled at one centre. Treatment duration will be 28 days with 28 days post-treatment follow-up.