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Hepatitis 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: NCT00686777 Completed - Clinical trials for Hepatitis C, Chronic

Pegylated Interferon (PEG-IFN) Alfa-2b and Low Dose Ribavirin for the Treatment of Chronic Hepatitis C Patients With Genotype 1 High Viral Load and Low Body Weight (Study P05172)(COMPLETED)

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

The objective is to evaluate the efficacy and safety of the combination therapy with subcutaneous (SC) Pegylated Interferon (PEG-IFN) alfa-2b 1.5 ug/kg/week plus low-dose ribavirin administered for 48 weeks in participants with chronic hepatitis C virus (HCV) who are infected with HCV genotype 1 high viral load, and weigh 50 kg or less.

NCT ID: NCT00686517 Completed - Hepatitis C Clinical Trials

Evaluation of Peginterferon Alfa-2b Monotherapy and Combination With Ribavirin in Participants With Acute Hepatitis C (P03552/MK-4031-137)

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

The objective of this study is to evaluate the efficacy of three regimens of pegylated interferon-alfa 2b (PEG-IFN) either as monotherapy or in combination with ribavirin in participants with acute hepatitis C. After 12 weeks of observation from disease onset, participants will receive one of the following regimens: (1) a 24-week course of PEG-IFN monotherapy (PEG-IFN 24); or (2) a 12-week course of PEG-IFN monotherapy (PEG-IFN-12); or (3) a 12-week course of PEG-IFN in combination with ribavirin (PEG-IFN + RVB 12). After the treatment period, participants will enter a 12-month follow-up.

NCT ID: NCT00684671 Completed - Hepatitis B Clinical Trials

Evaluation of Immune Memory to Twinrix or Comparator by Challenge Dose Administration 4 Years After Primary Vaccination

Start date: May 26, 2008
Phase: Phase 4
Study type: Interventional

Only subjects who participated in the primary study will be invited to participate in the extension phase and the challenge dose phase of this study.

NCT ID: NCT00684268 Completed - Hepatitis C Clinical Trials

Intravenous Silibinin in Combination With Peg-interferon and Ribavirin in Nonresponders

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

By chance the investigators found that iv. silibinin has a potent antiviral effect against the hepatitis C virus. Based on the results of the dose finding study (published) te optima dosing schedule is explored.This study will be evaluate whether the highest active dose given for the optimal time combined with standard of care will result in a sustained virologic response (=cure of hepatitis C).

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: NCT00679692 Completed - Clinical trials for Hepatocellular Carcinoma

Evaluation the Growth Factors(IGF-1,IGFBP-3and HGH)in Patients With Chronic Liver Disease

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

BACKGROUND The insulin-like growth factor system (IGFs) plays an important role in cell growth and differentiation. Nevertheless, the roles played by insulin-like growth factor-1 (IGF-1), insulin-like growth factor binding protein-3 (IGFBP-3) and human growth hormone (HGH) in the progression of chronic liver disease remain to be elucidated and investigated. METHODS The subjects in the present study included 60 healthy controls, 30 hepatitis patients, 60 liver cirrhosis patients and 60 untreated hepatocellular carcinoma patients. Blood was drawn by venipuncture into Venoject tubes. To find the possible correlations between liver damage and IGFs, serum IGF-1, GH, IGFBP-3 concentration and related biochemical parameters were measured. We used immunoradiometric assay to determine the levels of IGF-1, HGH and IGFBP-3 in serum.

NCT ID: NCT00674908 Completed - Hepatitis B Clinical Trials

Phase IV Interchangeability Study of a Liquid Pentavalent Combination Vaccine

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

The objective of this study is to compare the Safety and Immunogenicity of a mixed sequence of 2 different pentavalent vaccines (Diphtheria-Tetanus- Pertussis, Hepatitis B and Hib combination Vaccines) with single sequence of Shan 5 in infants.

NCT ID: NCT00674492 Completed - Hepatitis C Clinical Trials

Hepatitis C Virus (HCV) Treatment Completion or Withdrawal

Start date: May 2008
Phase: N/A
Study type: Observational

Qualitative pilot study of patients' views of their experience with antiviral treatment for hepatitis C.