View clinical trials related to Hepatitis C.
Filter by:The purpose of this study is to examine the efficacy of a brief motivational intervention on the cumulative incidence of Hepatitis C.
The objective of the study is to evaluate the safety and efficacy of celgosivir plus peginterferon alfa-2b, with or without ribavirin, for 12 weeks in patients with chronic hepatitis C genotype 1 infection.
The purpose of this study is to evaluate the efficacy and safety of low-dose interferon-alfa-2b plus ribavirin compared to the standard-dose of the same combination in patients with chronic hepatitis C.
Objectives: Primary To compare the sustained virologic response (SVR) of PEGIntron plus ribavirin among patients receiving 48 weeks versus 72 weeks of therapy (defined as undetectable HCV RNA level 24 weeks after discontinuing therapy). Secondary - To evaluate the safety and tolerability PEG Intron in combination with ribavirin for treatment of Chronic Hepatitis C (CHC) infection in patients co-infected with Human Immunodeficiency Virus (HIV). - To determine the early virologic response of patients receiving PEGIntron plus ribavirin at Treatment Week 24 Study Design: All qualifying patients will enter the treatment phase and be dosed as follows: Peginterferon a-2b 1.5mg/kg by subcutaneous route once weekly plus Ribavirin: - 800 mg (400 mg bid) if body weight < 65 kg - 1000 mg (400 mg a.m. and 600 mg p.m.) if body weight > 65 kg and < 85 kg - 1200 mg (600 mg bid) if body weight > 85 kg and < 105 kg - 1400 mg (600 mg a.m. and 800 mg p.m.) if body weight > 105 kg At Treatment Week 24, all participants with detectable HCV-RNA will be discontinued from treatment and followed for a Post Treatment period of 24 weeks. Participants with undetectable HCV-RNA values at Treatment Week 24 will be randomized to either: - Group A: an additional 24 weeks of previously assigned Peginterferon a-2b + Ribavirin therapy, for a total of 48 weeks of treatment. - Group B: an additional 48 weeks of previously assigned Peginterferon a-2b + Ribavirin therapy, for a total of 72 weeks of treatment. Study Population: 300 HIV infected adults with chronic hepatitis C infection who have not been treated previously with interferon therapy. Dosage and Administration: Peginterferon a-2b 1.5mg/kg by subcutaneous route once weekly plus Ribavirin: - 800 mg (400 mg bid) if body weight < 65 kg - 1000 mg (400 mg a.m. and 600 mg p.m.) if body weight > 65 kg and < 85 kg - 1200 mg (600 mg bid) if body weight > 85 kg and < 105 kg - 1400 mg (600 mg a.m. and 800 mg p.m.) if body weight > 105 kg Efficacy Evaluations: Laboratory analysis, liver biopsies, quality of life assessments, and changes in Peginterferona-2b and Ribavirin dosages will be obtained. Safety Evaluations: - Assessment of laboratory evaluations - vital signs - incidence and severity of adverse experiences - dose adjustments - premature withdrawal for safety reasons - progression of disease as measured by HCV viral load - AIDS defining events
HRN-003 STUDY SYNOPSIS OBJECTIVE: To compare the Sustained Virologic Response (SVR) of PEGIntron plus ribavirin among patients receiving a fixed dose of PEGIntron versus weighted-adjusted dosing. OVERVIEW OF STUDY DESIGN: This is a multi-center, randomized, open-label clinical trial using PEGIntron weight-adjusted dose by subcutaneous injection weekly + ribavirin by mouth twice daily for 48 weeks OR PEGIntron fixed dose by subcutaneous injection weekly + ribavirin by mouth twice daily for 48 weeks. STUDY POPULATION: 600 Adult patients with chronic hepatitis C virus infection who have previously failed to achieve a sustained virologic response following interferon alfa or interferon alfa-2b plus ribavirin therapy. DOSAGE AND ADMINISTRATION: Eligible participants will be randomized to receive PEGIntron weight-adjusted dose (1.5 mg/kg) by subcutaneous injection weekly + ribavirin 400 mg by mouth twice daily for 48 weeks OR PEGIntron fixed dose (150 mg if weight > than 80 kg or 100 mg if weight < 80 KG) by subcutaneous injection weekly + ribavirin 400 mg by mouth twice daily for 48 weeks. EFFICACY EVALUATIONS: Laboratory analysis, quality of life assessments, and change in study medication doses will be obtained. SAFETY EVALUATIONS: Assessment of laboratory evaluations, vital signs, incidence and severity of adverse experiences and progression of disease, as measured by HCV viral load. STUDY DESIGN This is a treatment protocol to evaluate the antiviral efficacy, safety and tolerability polyethylene glycol (PEG) conjugated interferon alfa-2b (PEGIntron) for the treatment of chronic hepatitis C virus infection in patients who have previously failed to achieve a sustained virologic response following interferon alfa or interferon alfa-2b plus ribavirin therapy. Patients will be stratified according to their response to the previous course of therapy (i.e. non-reponse or relapse virologic pattern This is a multi-center, randomized, open-label clinical trial that will involve approximately 25 sites with an anticipated enrollment of 600 patients over a six-month period. Eligible participants will be randomized to receive PEGIntron weight-adjusted dose (1.5 mg/kg) by subcutaneous injection weekly + ribavirin 400 mg by mouth twice daily for 48 weeks OR PEGIntron fixed dose (150 mg if weight > than 80 kg or 100 mg if weight < 80 KG) by subcutaneous injection weekly + ribavirin 400 mg by mouth twice daily for 48 weeks. - Group A: PEGIntron weight -adjusted dose (1.5 mg/kg) by subcutaneous injection weekly + ribavirin 400 mg by mouth twice daily for 48 weeks (Total therapy x 48weeks). - Group B: PEGIntron fixed dose (150 mg if weight > than 80 kg or 100 mg if weight < 80 KG) by subcutaneous injection weekly + ribavirin 400 mg by mouth twice daily for an additional 48 weeks (Total therapy x 48 weeks).
The primary aim of this investigation is to evaluate the effect of a combined antiviral, antifibrotic and antioxidant treatment on the progression of liver disease in patients with hepatitis C who either abstain from alcohol or continue to drink. All subjects are given state-of-the-art antiviral treatment (pegylated interferon + ribavirin), supplemented with either placebo or polyenylphosphatidylcholine (PPC), a purified soybean extract consisting of 95-96% polyunsaturated phosphatidylcholines (PC) and which has both antifibrotic and antioxidant properties. Secondary aims are to verify whether moderate alcohol consumption interferes with the antiviral effect of pegylated interferon + ribavirin on HCV and to validate the reliability of various circulating markers as substitute for liver biopsies to indicate the stage of liver pathology and its propensity for progression.
Data have suggested that consensus interferon (CIFN) has greater antiviral activity in vitro compared with interferon alfa-2a or alfa-2b. Several clinical studies also suggest that CIFN has greater antiviral activity in patients with genotype 1 hepatitis C infection, particularly if given as a daily injection. These data indicate that the use of a regimen of daily CIFN and ribavirin will lead to greater virologic response rates compared with pegylated interferon alfa-2b and ribavirin in patients with genotype 1 infection, with comparable adverse events. Emerging data indicate that HCV genotype 1 patients with a delayed virologic response to initial therapy may benefit from an extended duration of therapy. Therefore, the goals of this pilot study are to determine the tolerability and efficacy of daily CIFN plus ribavirin when given for 52 weeks or an extended duration of therapy. The target population will consist of "difficult-to-treat" patients, defined as having the following characteristics: genotype 1, a North American patient population, predominantly male gender, and no specific exclusions for pre-existing psychiatric or substance abuse co-morbidities.
A.OVERVIEW This is a 26 week study examining the ability of paroxetine (Paxil) to prevent the development of depression and neurotoxicity in patients receiving either 3 million units of subcutaneous IFN(interferon-alpha-2b) 3 times/week (plus ribavirin, 1000-1200 mg/d)) or PEG (polyethylene glycol) interferon-alpha-2b (1.5 micrograms/kg one time a week) and ribavirin (800 to 1,400 mg a day) for chronic hepatitis C (CHC). The IFN plasma half life (t1/2 of 24 to 34 hours) of PEG, a CHC treatment recently approved by the FDA, is significantly prolonged allowing for once a week dosing. Studies indicate that the side effect profile of the two forms of IFN-alpha treatment are very similar. CHC patients will be screened for study eligibility, and a total of 100 CHC patients between the ages of 18 and 65 years old will be enrolled across three sites (30 at Emory site and a combination of 30 from the University of Pennsylvania, Rush-Presbyterian-Saint Lukes Medical Center in Chicago and Montefiore Medical Center in New York.) Two weeks prior to treatment with subcutaneous IFN-alpha-2b, patients who meet inclusion and exclusion criteria will be stratified on the basis of a history of major depression and then randomly assigned to paroxetine or placebo in double blind fashion.
Genotype 1 hepatitis C virus (HCV) patients who did not respond (did not lose virus during treatment) or relapsed (virus went away on treatment but came back after treatment was stopped) after treatment with at least twelve weeks of a pegylated (long-acting) interferon and ribavirin will be considered for this study. There are two purposes to this study: first, to determine how rosiglitazone, a medicine used to treat diabetes, affects the HCV viral load; and second, to determine if treatment of insulin resistance with rosiglitazone prior to therapy for HCV will improve sustained virologic response (loss of virus that continues beyond six months after completion of HCV therapy) to HCV therapy.
The purpose of this study is to see which of two doses of PEG (polyethylene glycol) interferon alfa-2b in combination with Ribavirin for 48 weeks is more effective at elimination of hepatitis C. The primary objective of this study is to compare the efficacy of Induction PEG-Interferon alfa-2b (PEG-Intron) and Ribavirin (Rebetol) to standard PEG-Interferon alfa-2b (PEG-Intron) and Ribavirin (Rebetol) in patients with chronic hepatitis C.