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Hepatitis, Chronic clinical trials

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NCT ID: NCT00304551 Completed - Liver Cirrhosis Clinical Trials

A Study of Peginterferon Alfa-2a in Combination With Ribavirin in Chronic Hepatitis C (CHC) Patients With Compensated Liver Cirrhosis (LC)

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

This study evaluated the clinical response of the efficacy and safety of the combination therapy of peginterferon alfa-2a and ribavirin, compared with an antiviral treatment-free group in CHC patients with compensated LC. Additionally, this study evaluated the dosage reactivity and the pharmacokinetic characteristics of the combination therapy of peginterferon alfa-2a and ribavirin in CHC patients with compensated LC.

NCT ID: NCT00302081 Completed - Clinical trials for Hepatitis C, Chronic

Three Regimens of PegIntron Plus Ribavirin in Previously Untreated Chronic Hepatitis C, Genotype 2 or 3 (Study P03548)

Start date: August 2003
Phase: Phase 3
Study type: Interventional

This is a randomized, open-label, multinational study designed to evaluate the "standard" regimen, PegIntron 1.5 µg/kg subcutaneously once weekly plus ribavirin 800-1200 mg daily [Arm PEG2b 1.5/R (24 weeks)], compared to a lower dose regimen, PegIntron 1.0 µg/kg subcutaneously once weekly plus ribavirin 800-1200 mg daily [Arm PEG2b 1.0/R (24 weeks)], using a 24 week treatment duration for both arms. Additionally, the study examined the efficacy of reduced treatment duration: PegIntron 1.5 µg/kg subcutaneously once weekly plus ribavirin 800-1200 mg for 16 weeks [Arm PEG2b 1.5/R (16 weeks)] .

NCT ID: NCT00299936 Completed - Chronic Hepatitis C Clinical Trials

Comparison of PEG-Intron and Two Different Doses of Ribavirin for the Treatment of Chronic Hepatitis C In Treatment Naïve Subjects

Start date: n/a
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare PEG-interferon alfa-2b and two different doses of rivavirin for the treatment of chronic hepatitis C in previously untreated adult subjects

NCT ID: NCT00298714 Completed - Chronic Hepatitis C Clinical Trials

Effects of Losartan on Hepatic Fibrogenesis in Chronic Hepatitis C

Start date: March 2003
Phase: Phase 4
Study type: Interventional

There is evidence on the beneficial effects of the administration of angiotensin II type 1 (AT1) receptors antagonists on liver fibrosis in hepatic stellate cells, experimental models of liver fibrosis in rodents and limited information in chronic hepatitis C with mild fibrosis. The purpose of this study is to investigate the effect of long-term administration of oral Losartan, an AT1 receptor antagonist, on liver fibrogenesis in patients with chronic hepatitis C and fibrosis F2-F3 (METAVIR score).

NCT ID: NCT00298363 Completed - Chronic Hepatitis B Clinical Trials

Study Comparing Tenofovir Disoproxil Fumarate (TDF), Emtricitabine (FTC)/TDF, and Entecavir (ETV) in the Treatment of Chronic HBV in Subjects With Decompensated Liver Disease.

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

This study was designed to evaluate and compare the safety and tolerability of tenofovir disoproxil fumarate (TDF), emtricitabine (FTC)/TDF, and entecavir (ETV) in the treatment of hepatitis B patients with decompensated liver disease. Safety was assessed by evaluating adverse events (AEs) and laboratory abnormalities. Efficacy was assessed by evaluating reductions in Child-Pugh-Turcotte (CPT) and Model for End Stage Liver Disease (MELD) scores, reductions in hepatitis B virus (HBV) deoxyribonucleic acid (DNA), changes in liver enzymes, development of drug-resistant mutations, and generation of antibody to virus. A maximum randomized treatment duration of 168 weeks was planned. Since subjects with decompensated liver disease were enrolled into this study, it was necessary to provide early intervention strategies if profound viral suppression was not expeditiously achieved. For this reason, subjects with a decrease in plasma HBV DNA from baseline of < 2 log_10 copies/mL and plasma HBV DNA > 10,000 copies/mL (or plasma HBV DNA > 1,000 copies/mL for subjects who entered the study with HBV DNA < 10,000 copies/mL) at Week 8 had the option to start open-label FTC/TDF and continue in the study. Subjects with a virologic breakthrough or who had plasma HBV DNA levels remaining > 400 copies/mL (confirmed) at or after 24 weeks of treatment could have been unblinded at the investigator's discretion for selection of alternative anti-HBV therapy that may have included open-label FTC/TDF. If study drug was permanently discontinued, immediate initiation of another anti-HBV regimen was strongly recommended.

NCT ID: NCT00291616 Completed - Chronic Hepatitis B Clinical Trials

Efficacy Study of Thymosin alpha1 & Pegylated Interferon-alpha2a to Treat Chronic Hepatitis B

Start date: December 2005
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine the optimal treatment duration of antiviral therapy for chronic hepatitis B.

NCT ID: NCT00287235 Completed - Liver Cirrhosis Clinical Trials

Efficacy of Albumin Dialysis to Treat Patients With Hepatic Encephalopathy Using The Molecular Adsorbent Recirculating System (MARS)

Start date: September 2000
Phase: N/A
Study type: Interventional

The primary objective of the study was to compare the efficacy, safety and tolerability of Extracorporeal Albumin Dialysis (ECAD) using the Molecular Adsorbent Recirculating System (MARS®) device in improving severe HE by 2 grades compared to Standard Medical Therapy (SMT) in patients with chronic End Stage Liver Disease (ESLD) during a 5 day study period.

NCT ID: NCT00286871 Completed - Chronic Hepatitis C Clinical Trials

Randomized Controlled Trial in Liver Transplant Recipients Treated in Steroid Sparing Regimen

Start date: February 2006
Phase: Phase 1
Study type: Interventional

Liver transplant subjects will be given Mycophenolate (MMF) and Tacrolimus in order to help prevent post-transplant rejection.

NCT ID: NCT00277862 Completed - Hepatitis C Clinical Trials

Pegylated Interferon and Ribavirin Therapy in Chronic Hepatitis Genotype 4

Start date: April 2002
Phase: Phase 4
Study type: Interventional

Genotype 4 is the least-studied hepatitis C virus genotype and was considered a difficult to treat genotype due to the disappointing response of chronic hepatitis C genotype 4 to conventional interferon monotherapy. Recent reports showed that pegylated interferon and ribavirin combination therapy markedly increased the SVR rate to 55-70%. The duration of treatment has not been accurately defined. The main objective of this is to assess the duration of pegylated interferon ribavirin therapy in chronic hepatitis genotype 4 and assess the clinical utility of rapid and early virologic response in determining the optimal duration of peg interferon ribavirin therapy in chronic hepatitis C.

NCT ID: NCT00277576 Completed - Chronic Hepatitis B Clinical Trials

Safety Study of HBV DNA Vaccine to Treat Patients With Chronic Hepatitis B Infection

Start date: January 2006
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate how well the vaccine is tolerated at sites where administrations are given and any effects it may have on subjects' wellbeing. The study will also test the ability of vaccine to reduce hepatitis B disease.