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Hepatitis C, Chronic clinical trials

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NCT ID: NCT00088504 Completed - Hepatitis C Clinical Trials

Merimepodib (MMPD) in Triple Combination for the Treatment of Chronic Hepatitis C

Start date: July 2004
Phase: Phase 2
Study type: Interventional

This trial is designed to test whether or not the addition of merimepodib (MMPD) to the standard therapy of pegylated interferon and ribavirin will result in a positive treatment response for people who have not previously responded to this therapy. Approximately 315 subjects will be enrolled in this research study at approximately 55 clinical sites in the United States. There will be three study groups. Everyone in the study will receive Pegasys® (pegylated interferon) and Copegus® (ribavirin) at the normally prescribed doses. Two of the groups will also receive the study drug merimepodib (MMPD) twice a day, one group at each dose level being tested. The third group will take a placebo instead of MMPD, with the Pegasys® and Copegus®. After the first 24 weeks of treatment, blood tests will be done to see if subjects are responding to treatment. If they are responding, they will continue receiving study treatment in the study for another 24 weeks. If they are not responding, they will stop study treatment. Everyone who is responding will be monitored for 24 weeks after the last dose of medication, to see how long the response lasts. Evaluations will be performed during the study to look at the safety of the Pegasys®/Copegus® and MMPD or placebo combination, and to see how the combination is working by measuring Hepatitis C Virus in the blood. At some of the clinical sites performing the study, some subjects may also participate in additional testing to look at the metabolism of the drugs, or to look at the immune response to Hepatitis C virus infection and treatment.

NCT ID: NCT00088140 Completed - Clinical trials for Hepatitis C, Chronic

A Caspase Inhibitor in Chronic Hepatitis C (HCV) Patients

Start date: July 2004
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine if IDN-6556, when given orally, is safe and effective in patients with chronic hepatitis C virus infection.

NCT ID: NCT00087646 Completed - Clinical trials for Hepatitis C, Chronic

REPEAT Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Therapy in Combination With COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C (CHC) Who Did Not Respond to Previous PegIntron (Peginterferon Alfa-2b (12KD))/Ribavirin Combination Therapy

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

This 4 arm study is designed for patients with CHC who have not responded to peginterferon alfa-2b (12KD)/ribavirin combination therapy. In these patients, the effects of lengthening the duration of treatment, as well as including an initial 12-week period of high-dose PEGASYS (360 micrograms sc), are compared with the standard combination therapy of PEGASYS (180 micrograms sc) and ribavirin (1000-1200mg po). The anticipated time on study treatment is 1-2 years and the target sample size is 500+ individuals.

NCT ID: NCT00087633 Completed - Clinical trials for Hepatitis C, Chronic

PHOENIX Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) and COPEGUS (Ribavirin) Administered After Liver Transplantation for Hepatitis C.

Start date: October 2004
Phase: Phase 4
Study type: Interventional

This 2-arm study was designed to evaluate the efficacy, safety, and tolerability of prophylactic PEGASYS plus COPEGUS after liver transplantation for hepatitis C, compared to initiation of antiviral therapy at the time of clinical recurrence of hepatitis C infection. The anticipated time on study treatment was 3-12 months, and the target sample size was 100-500 individuals.

NCT ID: NCT00087607 Completed - Clinical trials for Hepatitis C, Chronic

PEAK Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With COPEGUS (Ribavirin) in Interferon-Naive Patients With Chronic Hepatitis C (CHC).

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

This study will examine the viral kinetics and pharmacokinetics of PEGASYS plus ribavirin and PEG-Intron plus ribavirin in interferon-naive patients with CHC. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

NCT ID: NCT00087594 Completed - Clinical trials for Hepatitis C, Chronic

A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With Copegus (Ribavirin) in Patients With Chronic Hepatitis C (CHC) Enrolled in a Methadone Maintenance Treatment Program.

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

This study will evaluate the safety and tolerability of PEGASYS plus ribavirin in previous intravenous (iv) drug users who have CHC and are currently enrolled in a methadone maintenance treatment program. The anticipated time on study treatment is 1-2 years, and the target sample size is <100 individuals.

NCT ID: NCT00087568 Completed - Clinical trials for Hepatitis C, Chronic

A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With Ribavirin in Patients With Chronic Hepatitis C (CHC) Previously Treated With PEG-Intron + Ribavirin

Start date: December 2002
Phase: Phase 4
Study type: Interventional

This study will evaluate the efficacy, safety and tolerability of PEGASYS plus ribavirin in patients with CHC who could not tolerate or were not responsive to 12 weeks of therapy with PEG-Intron plus ribavirin. The anticipated time on study treatment is 1-2 years, and the target sample size is >100 individuals.

NCT ID: NCT00086541 Completed - Chronic Hepatitis C Clinical Trials

Daily-Dose Consensus Interferon and Ribavirin: Efficacy of Combined Therapy

Start date: June 2004
Phase: Phase 3
Study type: Interventional

This Phase 3 clinical study is designed to evaluate the safety, tolerability, and efficacy of two dose levels of Infergen (interferon alfacon-1, CIFN) plus Ribavirin administered daily for 48 weeks and no treatment in patients chronically infected with hepatitis C who are nonresponders to previous pegylated interferon alfa plus ribavirin therapy. Patients are randomized 1:1:1 to receive Interferon Alfacon-1 (9 or 15 µg) + Ribavirin (both administered daily) or no treatment for up to 48 weeks. The protocol and informed consent form that will be used must be approved by the Investigator's Institutional Review Board (IRB)/Independent Ethics Committee (IEC) before the study is initiated.

NCT ID: NCT00084279 Completed - Chronic Hepatitis C Clinical Trials

CIFN and IFN γ-1b With or Without Ribavirin for Treatment of Chronic Hepatitis C (Nonresponders)

Start date: April 2004
Phase: Phase 2
Study type: Interventional

To evaluate the safety and tolerability of two different doses of Consensus Interferon-Alpha and Interferon Gamma-1b with or without ribavirin in patients with chronic hepatitis C who are non-responders to PEG-IFN-a 2a or PEG-IFN-a 2b plus ribavirin.

NCT ID: NCT00081770 Completed - Clinical trials for Hepatitis C, Chronic

Peginterferon Dose Evaluations for Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1 (Study P03471)

Start date: March 2004
Phase: Phase 3
Study type: Interventional

The objective is to compare the safety and efficacy of the following three treatment regimens in previously untreated adult subjects with chronic hepatitis C infected with Genotype 1: (1) PegIntron 1.5 µg/kg/wk in combination with weight based REBETOL (800-1400 mg/day); (2) PegIntron 1µg/kg/wk in combination with weight based REBETOL (800-1400 mg/day); and (3) PEGASYS 180 µg/wk plus COPEGUS 1000-1200 mg/day.