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Hepatitis, Chronic clinical trials

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NCT ID: NCT00528528 Completed - Chronic Hepatitis C Clinical Trials

An Open-Label Study of Telaprevir Administered Every 12 or 8 Hours in Combination With One of Two Pegylated Interferons and Ribavirin in Treatment-Naive Genotype 1 Chronic Hepatitis C Participants

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

The purpose of this study is to explore the efficacy, safety, tolerability, pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time), and pharmacokinetic-pharmacodynamic relationships of telaprevir administered in two different doses in combination with two standard therapies commercially available for chronic (lasting a long time) genotype 1 Hepatitis (inflammation of the liver) C virus (HCV) infection.

NCT ID: NCT00527540 Completed - Hepatitis C Clinical Trials

Effectiveness and Side Effects of Pegylated Interferon Alpha-2a (Pegaferon®) Plus Ribavirin in the Patients With Chronic Hepatitis C

Start date: February 2007
Phase: Phase 3
Study type: Interventional

Pegylation of interferon prolongs the medication half-life which has resulted in Pegylated Interferon (PEG-IFN) as the new modality for treatment of chronic hepatitis C. We current this clinical trial to assess the efficacy and safety of domestic PEG-IFN alpha-2a (Pegaferon®) in the patients with chronic hepatitis C.

NCT ID: NCT00519792 Completed - Chronic Hepatitis C Clinical Trials

Phase 1b Study of Omega DUROS® in Patients With Chronic Hepatitis C Who Relapsed After Prior Treatment

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

Omega DUROS® is an implantable drug delivery system designed to deliver omega interferon subcutaneously at a constant rate for 90 days. This study is being performed to evaluate the safety and antiviral effects of omega interferon delivered by the Omega DUROS® device in combination with ribavirin in subjects with chronic Hepatitis C genotype 1.

NCT ID: NCT00513968 Completed - Chronic Hepatitis B Clinical Trials

Phase I Study to Investigate the Safety and Efficacy of HBV DNA Vaccine

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

This study will evaluate the safety and immunogenicity of a novel mixed plasmid DNA (HB-110) combined with an antiviral agent (Adefovir) for the patients with chronic Hepatitis B infection.

NCT ID: NCT00507689 Completed - Chronic Hepatitis B Clinical Trials

Truvada Versus Truvada Plus Hepatitis B Immunoglobulin (HBIg) in Prevention of Chronic Hepatitis B Recurrence Post Liver Transplant

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

The objective of this 96-week study was to evaluate the safety and antiviral efficacy of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF, coformulated; Truvada®) with or without hepatitis B immunoglobulin (HBIg) in preventing the recurrence of chronic hepatitis B following liver transplantation, in participants who were chronically infected with hepatitis B prior to transplantation. Prior to enrollment, participants were required to have received at least 12 weeks of HBIg therapy following liver transplantation. Enrolled participants then received FTC/TDF plus HBIg for an initial 24-week pre-randomization treatment period. Participants who completed the pre-randomization period and who achieved sustained viral suppression were randomized to continue treatment with FTC/TDF with or without HBIg for an additional 72 weeks (randomized period). The antiviral efficacy of treatment was assessed by measuring hepatitis B virus levels in the blood (HBV DNA). Safety and tolerability was monitored by assessing adverse events and various laboratory parameters.

NCT ID: NCT00507507 Completed - Chronic Hepatitis B Clinical Trials

A Study to Compare Tenofovir DF Versus the Combination of Emtricitabine Plus Tenofovir DF for the Treatment of Chronic Hepatitis B in Patients With Normal Alanine Aminotransferase (ALT)

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

The main objective of the study was to evaluate the antiviral activity of tenofovir disoproxil fumarate (tenofovir DF) monotherapy versus emtricitabine (FTC) plus tenofovir DF combination therapy for the treatment of chronic hepatitis B (HBV) in participants in the immune tolerant phase of HBV infection. The efficacy of tenofovir DF monotherapy versus FTC plus tenofovir DF combination therapy was evaluated for suppression of the virus (decrease in HBV DNA), serological response (generation of antibodies to the virus), biochemical response (changes in liver enzymes), and the development of drug-resistant mutations. The safety and tolerability of both tenofovir DF monotherapy and FTC plus tenofovir DF were evaluated by routine monitoring for adverse events and changes in laboratory parameters. Participants were randomized in a 1:1 ratio to receive tenofovir DF monotherapy or FTC plus tenofovir DF. All subjects were to continue on blinded study medication until the last subject reached Week 192. Participants who permanently discontinued study drug (on or before Week 192) were followed for a 24-week treatment-free follow-up period, or until initiation of alternative HBV therapy, whichever occurred first. Subjects who discontinued study drug on or after Week 48 because of hepatitis B surface antigen (HBsAg) loss or seroconversion to antibody to hepatitis B surface antigen (anti-HBs), however, were to have returned for their regularly scheduled through Week 192 and every 16 weeks thereafter until the last subject reached Week 192.

NCT ID: NCT00503347 Completed - Hiv Infections Clinical Trials

Bavituximab Repeat-Dose Trial in Patients Co-Infected With Chronic Hepatitis C Virus and Human Immunodeficiency Virus

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

This trial is designed to assess the safety, tolerability, pharmacokinetics and viral kinetics after multiple infusions of bavituximab in patients co-infected with HCV and HIV.

NCT ID: NCT00502099 Completed - Hepatitis C Clinical Trials

Comparison of Pegasys Versus Peg-Intron for Treatment of Chronic Hepatitis C Genotype 4

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

Genotype 4 hepatitis C virus is the cause of approximately 20% of the 170 million cases of chronic hepatitis C in the world. Although rare in western nations, genotype 4 is the most common variant of the hepatitis C virus in Egypt and is also found throughout Africa and the Middle East. Early reports on the treatment of patients with genotype 4 chronic hepatitis C with interferon-alfa (IFN)-alfa monotherapy indicate poor rates of sustained viral response (SVR). With the introduction of ribavirin combination therapy and with pegylation of the IFN alfa molecule, however, response rates have improved dramatically, and current clinical trial data indicate that SVR rates between 43 and 79% are attainable in genotype 4 patients who are receiving pegylated IFN alfa plus ribavirin for 48 weeks. Clinical advances to optimize treatment for each patient have also been made, and tailored treatment options are now being developed that are comparable to the treatment approaches for genotype 1, 2, and 3 patients. A treatment duration of between 36 and 48 weeks appears to be optimal for most patients with chronic hepatitis C genotype 4.The aim of this study is to assess the efficacy and safety of pegylated interferon alpha 2a in patients with chronic hepatitis C genotype 4 in comparison to a historical cohort of patients treated with pegylated interferon alpha 2b

NCT ID: NCT00502086 Completed - Cirrhosis Clinical Trials

Efficacy and Safety of Viusid in Patients With Hepatic Cirrhosis Secondary to Hepatitis C Virus Infection.

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

The purpose of the study is to evaluate whether Viusid, a nutritional supplement, reduce the mortality and the complications (ascites, spontaneous bacterial peritonitis, hepatorenal syndrome, hepatic encephalopathy, gastrointestinal bleeding, sepsis and hepatocellular carcinoma) of patients with cirrhosis of the liver secondary to HCV infection in comparison with placebo, during 96 weeks of treatment.

NCT ID: NCT00495391 Completed - Chronic Hepatitis C Clinical Trials

Study of Nitazoxanide, Peginterferon Alfa-2a and Ribavirin for the Treatment of Hepatitis C

STEALTHC-2
Start date: July 2007
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine if nitazoxanide in combination with peginterferon alfa-2a and ribavirin is safe and effective in treating chronic hepatitis C in patients that have previously failed to respond to treatment with peginterferon and ribavirin.