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Hepatitis, Chronic clinical trials

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NCT ID: NCT00686790 Completed - Clinical trials for Hepatitis B, Chronic

Efficacy of Peginterferon Alfa-2b in Previously Untreated Subjects With Chronic Hepatitis B and D Co-infection (Study P04603)

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

The objective of this study is to determine the effectiveness of peginterferon alfa-2b 1.5 mcg/kg/week administered for 52 weeks (wk) in previously untreated participants coinfected with hepatitis virus B and D. After 52-week treatment and 52-week follow-up, the virologic, biochemical, and histological response will be evaluated.

NCT ID: NCT00680342 Completed - Chronic Hepatitis C Clinical Trials

Phase II Trial of Silymarin for Patients With Chronic Hepatitis C Who Have Failed Conventional Antiviral Treatment

SyNCH
Start date: April 2008
Phase: Phase 2
Study type: Interventional

Silymarin (Legalon), also known as milk thistle, is an alternative medicine commonly found in health food and vitamin stores. People with liver disease sometimes use silymarin because it is thought to have liver protecting effects; however, this benefit has not been proven. The purpose of this research study is to determine the effectiveness of silymarin and assess the safety of different silymarin doses in patients with varying severity of liver disease compared to a placebo (lactose pill). Eligible subjects will be randomized to treatment with placebo or one of two dosages of Legalon® 420 mg or 700 mg administered orally thrice daily. Investigators and subjects will be masked to treatment assignment. The study design includes a screening period during which patients will undergo full medical evaluation to verify protocol eligibility and a treatment period of 24 weeks during which time clinic visits and laboratory studies will be performed every 2-4 weeks to monitor for safety and efficacy of therapy. Subjects will continue to be followed for an additional 12 weeks after the completion of study medication to monitor for adverse events and investigate post-treatment outcomes. Participation in this research study requires the subject to travel to the clinic for at least 10 visits so recruitment will be limited to a geographically restricted area around participating clinical centers.

NCT ID: NCT00680173 Completed - Chronic Hepatitis C Clinical Trials

Peripheral Blood Mononuclear Cell (PBMC) Gene Expression in HCV Genotype 1 Patients

PBMC
Start date: August 2006
Phase: Phase 4
Study type: Interventional

Our previous collaborative studies has developed a molecular diagnosis tool, which is characterized with a prediction model consisting single nucleotide polymorphisms (SNPs), for assessing the efficacy of interferon combined therapy for chronic hepatitis C (CHC) patients prior to treatment. Aims of this project: 1. To analyze and validate the gene expression profiling dependent of treatment response to peg-interferon-α plus ribavirin combination therapy in CHC genotype-1 patients. 2. To select the candidate genes and establish a monitoring model assessing the efficacy of interferon treatment.

NCT ID: NCT00671671 Completed - Hepatitis C Virus Clinical Trials

Phase 1 Study To Evaluate Antiviral Activity Of Small Molecule Direct Antiviral Agent At Multiple Doses In Subjects With Chronically Infected Hepatitis C Virus.

Start date: April 2008
Phase: Phase 1
Study type: Interventional

Phase 1 study in HVC (Hepatitis C Virus) infected subjects to determine pharmacokinetics, safety and efficacy in subjects with no or inadequate response to prior treatment.

NCT ID: NCT00664625 Completed - Chronic Hepatitis C Clinical Trials

A Single Ascending Dose Study of BMS-791325 in HCV Infected Subjects

Start date: May 2008
Phase: Phase 1/Phase 2
Study type: Interventional

The primary purpose of this study is to evaluate the safety profile and tolerability of single oral doses of BMS-791325 in subjects with chronic hepatitis C infection

NCT ID: NCT00663208 Completed - Chronic Hepatitis C Clinical Trials

A Multiple Ascending Dose Study of Daclatasvir (BMS-790052) in Hepatitis C Virus Genotype 1 Infected Subjects

Start date: May 2008
Phase: Phase 2
Study type: Interventional

The primary purpose of this study is to assess the change in Hepatitis C Virus RNA during dosing with daclatasvir and during the follow-up period in subjects with chronic hepatitis C infection

NCT ID: NCT00661076 Completed - Clinical trials for Hepatitis B, Chronic

ADVANCE Study: A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) + Adefovir Dipivoxil in Patients With Hbe(-) Chronic Hepatitis B

Start date: August 2008
Phase: Phase 3
Study type: Interventional

This 3 arm study will compare the efficacy and safety of combination therapy with PEGASYS + adefovir dipivoxil (ADV) versus PEGASYS monotherapy, in HBeAg-negative chronic hepatitis B patients.Patients will be randomized to receive 1)PEGASYS 180 micrograms sc weekly + ADV 10mg po daily for 48 weeks, followed by ADV 10mg po monotherapy for an additional 48 weeks, and a further 48 week treatment-free follow-up, 2)PEGASYS 180 micrograms sc weekly + ADV 10mg po daily for 48 weeks, followed by a 96 week treatment-free follow-up, or 3)PEGASYS 180 micrograms sc monotherapy weekly for 48 weeks, followed by a 96 week treatment-free follow-up. The anticipated time on study treatment is 1-2 years, and the target sample size is <100 individuals.

NCT ID: NCT00656006 Completed - Chronic Hepatitis C Clinical Trials

A Study of Albuferon With Ribavirin in Interferon Alfa Naive Subjects With Chronic Hepatitis C Genotype 2 or 3

Start date: November 2005
Phase: Phase 2
Study type: Interventional

A Study of Albuferon with Ribavirin in Interferon Alfa Naive Subjects with Chronic Hepatitis C Genotype 2 or 3.

NCT ID: NCT00651209 Completed - Clinical trials for Hepatitis B, Chronic

A Single-arm Study Evaluating the Efficacy and Safety of Telbivudine With or Without add-on Tenofovir in Adults With HBeAg-positive Chronic Hepatitis B (CHB)

Start date: February 2008
Phase: Phase 4
Study type: Interventional

This study will evaluate the use of telbivudine for patients with HBeAg-positive CHB with an option to intensify treatment at Week 24 by adding tenofovir for patients who do not achieve HBV DNA non-detectability.

NCT ID: NCT00646503 Completed - Clinical trials for Hepatitis B, Chronic

Prospective Exploratory Study to Evaluate the Safety and Efficacy of Telbivudine in the Fifth Year of Treatment in Chinese Patients With Compensated Chronic Hepatitis B

Start date: March 2008
Phase: Phase 4
Study type: Interventional

This study will explore efficacy and safety of Telbivudine in the fifth year of treatment.