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Chronic Hepatitis C clinical trials

View clinical trials related to Chronic Hepatitis C.

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NCT ID: NCT00749138 Completed - Chronic Hepatitis C Clinical Trials

Fourteen Day Safety of Low-Dose Tamoxifen in Patients With Chronic Hepatitis C Who Have Failed Standard Medical Therapy

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

A short 14 day phase 1 study examining 6 monotherapy doses of oral tamoxifen for safety in chronic HCV patients who have failed standard treatment of peginterferon and ribavirin.

NCT ID: NCT00736242 Completed - HIV Infections Clinical Trials

Post-marketing Surveillance of HIV-infected Patients With Chronic Hepatitis C Treated With PegIntron Pen and Rebetol (Study P04584)

Start date: December 2005
Phase: N/A
Study type: Observational

The objective of the study was to assess the safety and efficacy of peginterferon alfa-2b (PEG-IFN alfa-2b) and ribavirin (RBV) administered to participants coinfected with Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV). Participants were treated by general practitioners in clinical practice as part of the post-marketing surveillance study. The study assessed the rates of eradication of the HCV and the rates of serious adverse events reported with PEG-IFN alfa-2b (1.5 ug/kg/week) and RBV (800-1200 mg/day) in common medical practice in Germany.

NCT ID: NCT00735969 Completed - Chronic Hepatitis C Clinical Trials

High-Dose Ribavirin and Peginterferon to Treat Chronic Hepatitis C Genotype 1

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

This study will evaluate the effectiveness of an experimental treatment regimen for hepatitis C (HCV). Standard treatment consists of combination therapy with ribavirin, taken by mouth twice a day, and Peginterferon, injected under the skin once a week. Hepatitis C genotypes 2 and 3 have a high success rate with this regimen, while genotype 1 is more difficult to treat. This study will determine if patients with genotype 1 respond better to treatment that uses a higher dose of ribavirin than the standard approved dose of 1,000 to 1,200 mg daily. Patients 18 years of age and older with chronic hepatitis C genotype 1 who have not been successfully treated with a standard course of Peginterferon and ribavirin may be eligible for this study. Participants eligible will receive Peginterferon plus twice the standard dose of ribavirin (2,000 to 2,400 mg daily) for 48 weeks. In addition to treatment, all patients receive undergo the following: Before Treatment: - Medical history and physical examination, symptom questionnaires, blood tests, urine collection, chest x-ray, electrocardiogram, liver ultrasound, Fibroscan (ultrasound to measure stiffness of the liver) and pregnancy test for women who are able to have children. - Patients with other medical conditions or special risk factors may have further evaluations before starting treatment. These may include, for example, eye evaluation for patients with diabetes, exercise stress test for people over age 40 or who have risk factors for heart disease and psychiatric evaluation for people who have depression or anxiety disorder. During Treatment - Periodic blood tests to monitor blood counts and viral levels. - Outpatient clinic visits every 4 weeks for the duration of the study for laboratory tests and review of symptoms and treatment side effects. Physical examinations and urine tests are done every 12 weeks. Following Completion of Treatment About 1 1/2 years after starting treatment, subjects are re-evaluated as they were at the start of treatment.

NCT ID: NCT00724776 Completed - Chronic Hepatitis C Clinical Trials

Albinterferon Alfa 2b Single Dose in Japanese Chronic Hepatitis C Patients

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

This study will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of albinterferon alfa 2b (alb-IFN) single dose in Japanese chronic hepatitis C patients

NCT ID: NCT00722358 Completed - Chronic Hepatitis C Clinical Trials

A Multiple Ascending Dose Study of BMS-650032 in HCV Infected Subjects

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

The primary purpose of this study is to assess the change in HCV RNA during dosing with BMS-650032 and during the follow-up period in subjects with chronic hepatitis C infection

NCT ID: NCT00704964 Completed - Hepatitis C Clinical Trials

Impact of Patient Support by the Medical Staff on Adherence to Therapy With PegIntron Plus Rebetol (Study P04413)

@dhere
Start date: May 2005
Phase: N/A
Study type: Observational

The objective of this study is to assess the impact of participant care and support on treatment adherence. PegIntron pen and Rebetol will be administered to participants with Hepatitis C Virus (HCV) in accordance with approved labeling. Sites will be categorized as providing high vs low level of participant management based on information about the level of participant support and management captured on the site questionnaire. Data on each participant will be collected by a physician on an electronic participant case report form (CRF) and by the participant via a questionnaire. Treatment completion rates will be analyzed based on the high vs low level of participant management. The hypothesis is that Physicians investing more time and effort into participant management achieve higher treatment completion rates among their hepatitis C patients than physicians offering less participant management measures.

NCT ID: NCT00687999 Completed - Insulin Resistance Clinical Trials

NIDDM and IR in Combination Therapy for CHC

Start date: December 2005
Phase: N/A
Study type: Interventional

The influence of insulin sensitivity and glucose tolerance on the effects of antiviral therapy for HCV remains unclear. The aim of the present study was (1) To elucidate the clinical and virological factors associated with sustained viral response in patients with combination therapy with PEG-IFN and ribavirin. (2) To clarify the influence of diabetes mellitus (DM), impaired glucose tolerance test (IGT) and insulin resistance (IR) on the HCV response to combination therapy with PEG-IFN and ribavirin. (3) To test the influence of combination therapy on HOMA IR

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: 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