Clinical Trials Logo

Hepatitis C, Chronic clinical trials

View clinical trials related to Hepatitis C, Chronic.

Filter by:

NCT ID: NCT00491179 Completed - Chronic Hepatitis C Clinical Trials

Retreatment of Dialysis Patients With Chronic Hepatitis C With Pegylated Interferon Alfa-2a Plus Low Dose Ribavirin

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

Chronic hepatitis C virus (HCV) infection is common in dialysis patients. Interferon (IFN)-based treatment for chronic hepatitis C has been the mainstay therapy in immunocompetent patients. Two meta-analyses evaluating the efficacy and safety of conventional IFN alfa monotherapy showed that the sustained virologic response (SVR) rates were 37% and 33%, respectively; and the corresponding dropout rates were 17% and 29.6%, respectively. The efficacy and safety of pegylated IFN alfa-2a and 2b in treating dialysis patients showed conflicting results, with a more favorable outcome of patients treated with pegylated IFN alfa-2a (135-180 μg/week: SVR 33-75%, well tolerated) than those treated with pegylated IFN alfa-2b (0.5-1.0 μg/week: SVR 12.5%, poorly tolerated), Currently, IFN-based therapy to treatment HCV infection should be initiated in dialysis stages, because the use of IFN in RT patients harbors high risks of acute graft rejection,and have low response rates under the concomitant use of immunosuppressive agents. Ribavirin, which has been used in combination with IFN to treat chronic hepatitis C in the general patients and achieve a higher SVR rate than IFN monotherapy, is considered contraindicated in dialysis patients with chronic hepatitis C due to the risk of severe hemolytic anemia. However, some pilot studies evaluating combined conventional IFN alfa plus low dose ribavirin (170-300 mg/day) showed SVR rates of 17%-66% after 24-48 weeks of treatment.In addition, a recent study including 6 patients with combination of pegylated IFN alfa plus low dose ribavirin also showed a SVR rate of 50%. Although dialysis patients have a higher SVR rate to conventional IFN or pegylated IFN monotherapy than patients with normal renal function for HCV therapy. More than half of these patients are relapsers or non-responders to IFN monotherapy. Retreatment of HCV-patients with normal renal function by combined pegylated IFN alfa plus ribavirin who fail to response to IFN monotherapy has achieved a SVR rate of 28%. Based on the long-term favorable outcome in dialysis patients who eradicate HCV, the aim of the study is to evaluate the efficacy and safety of retreatment by pegylated IFN alfa-2a plus low dose ribavirin in dialysis patients who fail to achieve HCV eradication by conventional or pegylated IFN alfa.

NCT ID: NCT00487318 Completed - Chronic Hepatitis C Clinical Trials

Fluvastatin, Rosuvastatin Added to Pegylated Interferon and Ribavirin

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

Hypothesis: addition of fluvastatin will increase the cure rate of standard anti-HCV therapy. Summary: This trial is limited to veterans in Oklahoma who qualify for care with the Veterans Administration. It is a randomized control format including genotypes 1 and 3. There will also be pilot arms for HCV carriers who present for screening already on a statin, who will be allowed to stay on their current statin or switched to another statin. In all ways, standard therapy as noted on pegylated interferon and ribavirin will be given per FDA package insert.

NCT ID: NCT00483938 Completed - Clinical trials for Hepatitis C, Chronic

IMPROVE Study(The Individualized Management With PEGASYS and Ribavirin Offering Viral Eradication): A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus Copegus (Ribavirin) in Patients With Chronic Hepatitis C (CHC) Non-Genotype 2/3.

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

This study will compare the efficacy and safety of 48 weeks and 72 weeks treatment with PEGASYS plus ribavirin in patients with non-genotype 2/3 chronic hepatitis C who, after 12 weeks of study treatment, have undetectable HCV-RNA or a >=2 log10 drop in HCV-RNA. Patients will be randomized to receive PEGASYS 180 micrograms sc weekly plus ribavirin (1000-1400mg) po daily for either 48 or 72 weeks, followed by 24 weeks of treatment-free follow-up. Patients with detectable HCV-RNA and <2 log10 drop in HCV-RNA at week 12 will discontinue therapy. The anticipated time on study treatment is 1-2 years, and the target sample size is 500 individuals.

NCT ID: NCT00475176 Completed - Chronic Hepatitis C Clinical Trials

S-Adenosyl Methionine (SAMe) to Treat Patients With Chronic Hepatitis C

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

This study will examine the effectiveness of S-adenosyl methionine (SAMe) in combination with peginterferon and ribavirin for treating hepatitis C virus. One out of three patients with hepatitis C develops cirrhosis of the liver, which can lead to liver failure or liver cancer. SAMe is a nutritional supplement that is made naturally in all cells of the body and acts to improve how the body handles stress. In laboratory experiments with liver cells, SAMe decreases the injury caused by liver toxins and improves the ability of interferon to block hepatitis C virus. Patients 18 years of age and older with hepatitis C infection who did not respond successfully to prior treatment with interferon and ribavirin or peginterferon and ribavirin may be eligible for this study. Participants receive the following treatment: - Peginterferon (given by injection) and ribavirin (taken by mouth) for 2 weeks - Washout period (no medications) for 4 weeks - SAMe (taken by mouth) for 2 weeks - Peginterferon, ribavirin and SAMe for 12-48 weeks, depending on patient response to treatment. Participants have a thorough physical evaluation before beginning treatment and again at the study's end. After starting treatment, patients return for clinic visits and blood tests weekly for the first several weeks, then less frequently (at 2-week, then 4-week and 8-week intervals until up to 72 weeks) to monitor symptoms, drug side effects, hepatitis C virus levels, liver enzyme levels and immune responses to hepatitis C.

NCT ID: NCT00475072 Completed - Clinical trials for Hepatitis C, Chronic

A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus Ribavirin in Hemophiliac Patients With Chronic Hepatitis C.

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

This study will evaluate the efficacy and safety of PEGASYS plus ribavirin in male patients with hemophilia A and chronic hepatitis C. All patients will receive PEGASYS 180 micrograms s.c. weekly plus ribavirin 1000-1200mg p.o. daily (depending on body weight) for 48 weeks. Following treatment there will be a 24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

NCT ID: NCT00474955 Completed - Clinical trials for Hepatitis C, Chronic

A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Chronic Hepatitis C and Chronic Renal Failure.

Start date: July 2007
Phase: Phase 4
Study type: Interventional

This single arm study will assess the efficacy and safety of PEGASYS in patients with chronic hepatitis C and end-stage renal disease, including patients on hemodialysis. Patients will receive PEGASYS at a dose of 180 micrograms weekly; those with a calculated glomerular filtration rate of <15mL/min will receive a reduced dose of 135 micrograms weekly. Following 48 weeks of treatment there will be a 24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

NCT ID: NCT00473993 Completed - Clinical trials for Hepatitis C, Chronic

Hepatitis C Among Opioid Addicts in Opioid Maintenance Treatment in Zurich, Switzerland

HepCOP
Start date: July 2007
Phase: N/A
Study type: Observational

Hepatitis C viral infection is common among opioid addicts in Zurich, Switzerland. The majority undergoes a maintenance treatment with methadone, heroin or buprenorphine. While stabilized by an opioid maintenance treatment (OMT)chronic hepatitis C can be treated with pegylated interferon plus ribavirin. As not sufficiently known, the results are comparable to the results of the treatment of nonaddicts. Our crossectional study investigates how many patients undergoing OMT are adequately investigated concerning hepatitis C. If not, why are they not adequately investigated and treated? Representative data are collected in the local clinics and medical practices involved in OMT in the Kanton of Zurich. The patients files are revised and the involved doctors are asked through a structured interview.

NCT ID: NCT00466336 Completed - Cirrhosis Clinical Trials

Prediction of Hepatic Fibrosis in Patients With Chronic Hepatitis C by Biochemical and Duplex Doppler Indices

Start date: January 2003
Phase: N/A
Study type: Observational

The purpose of our prospective study was to evaluate the value of Doppler parameters and compare the diagnostic accuracy of Doppler parameters with various biochemical indices in predicting significant hepatic fibrosis (≥ F2) and cirrhosis (F4) in chronic hepatitis C (CHC) patients.

NCT ID: NCT00466271 Completed - Chronic Hepatitis C Clinical Trials

Prediction of Significant Hepatic Fibrosis in HCV Carriers With PNALT by SAPI- A Validation Study

Start date: April 2007
Phase: N/A
Study type: Observational

The purpose of the study is to validate the diagnostic accuracy and reproducibility of SAPI to predict significant hepatic fibrosis in HCV patients with PNALT who are scheduled to receive combination therapy with pegylated interferon plus ribavirin and percutaneous liver biopsies.

NCT ID: NCT00446134 Completed - Chronic Hepatitis C Clinical Trials

Taribavirin Phase 2 Dose Finding Study for the Treatment of Hepatitis C Virus (HCV)

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

The objective of the study is to select an optimal dose of taribavirin by comparing the efficacy and safety of 3 taribavirin dose levels, 20, 25, and 30 mg/kg/day, versus ribavirin 800 to 1400 mg/day based on body weight, both administered in combination with peginterferon alfa-2b to therapy-naive patients with chronic Hepatitis C Virus (HCV) genotype 1 infection.