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Hepatitis C, Chronic clinical trials

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NCT ID: NCT00704717 Completed - Hepatitis C Clinical Trials

Evaluation of Patient Satisfaction in Hepatitis C Patients Treated With PegIntron Pen and Rebetol in Romania (Study P04301)

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

The objective of this study is to evaluate patient satisfaction in hepatitis C patients receiving PegIntron pen plus Rebetol. The rationale is that the effectiveness of treatment is correlated with adherence to the prescribed regimen which, in turn, is affected by the ease of use and accuracy of treatment administration. Since the PegIntron pen is a novel device, the results of this study will be used to improve the training of patients and healthcare providers in PegIntron pen use.

NCT ID: NCT00704522 Completed - Clinical trials for Hepatitis C, Chronic

Adherence in Patients Receiving PegIntron Pen/Rebetol for Hepatitis C in Conjunction With a Patient Assistance Program (Study P04281)(COMPLETED)

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

Patients receiving a patient assistance program during therapy for Hepatitis C will be enrolled into this study. All patients will receive PegIntron pen and Rebetol according to label and the patient assistance program. This study will be compared to similar studies from other clinics using various patient support programs for the purpose of designing future comparative phase IV studies.

NCT ID: NCT00704405 Completed - Clinical trials for Hepatitis C, Chronic

Safety and Efficacy of Vaniprevir (MK-7009) With Pegylated Interferon (Peg-IFN) and Ribavirin (RBV) in Treatment-Experienced Hepatitis C Virus (HCV) Participants (MK-7009-009)

Start date: March 27, 2009
Phase: Phase 2
Study type: Interventional

The purpose of this study is to test the safety, tolerability, and efficacy of 4 regimens of Vaniprevir + Peg-IFN and Ribavirin as compared to Placebo (PBO) + Peg-IFN/RBV. The primary hypotheses are that Vaniprevir is well tolerated, and that Vaniprevir 600 mg twice daily (b.i.d.) is superior to the control regimen for the percentage of non-cirrhotic (NC) participants achieving undetectable HCV ribonucleic acid (RNA) 24 weeks after the end of study therapy (SVR24).

NCT ID: NCT00703118 Completed - Clinical trials for Hepatitis C, Chronic

A Safety and Effectiveness Study of Telaprevir in Chronic, Genotype 1, Hepatitis C Patients That Failed Previous Standard Treatment

Start date: October 2008
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the safety, efficacy and tolerability of using two regimens of telaprevir (with and without delayed start) with standard treatment compared to standard treatment alone in participants with chronic, genotype 1, hepatitis C.

NCT ID: NCT00700401 Completed - Clinical trials for Hepatitis C, Chronic

POTENTE Study: A Study of Early Virological Response in Naive Patients With Chronic Hepatitis C, Genotype 2 or 3, Treated With PEGASYS (Peginterferon Alfa-2a (40KD)) Plus Copegus (Ribavirin).

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

This single arm study will investigate the predictive value of a week 4 virological response on sustained virological response in patients with chronic hepatitis C, genotype 2 or 3, treated with PEGASYS + Copegus. Eligible patients will be treated with PEGASYS 180 micrograms/week sc + Copegus 800mg/day po; those who have a virological response at week 4 will continue to be treated for 24 weeks, followed by a 24 week treatment-free follow-up. Non-responders at week 4 will be entered into a separate protocol (MV21371) to receive PEGASYS + Copegus for 24 or 48 weeks. The anticipated time on study treatment is 3-12 months, and the target sample size is 100 individuals.

NCT ID: NCT00695019 Completed - Clinical trials for Hepatitis C, Chronic

Interferon-alpha Lozenges for Prevention of Relapse in Hepatitis C

Start date: June 2009
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether lozenges of interferon-alpha that are dissolved in the mouth can prevent relapse in patients with hepatitis C virus infection who had a complete virologic response after receiving a combination of injected interferon-alpha and oral ribavirin.

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: NCT00687219 Completed - Liver Cirrhosis Clinical Trials

Efficacy and Safety of Peginterferon Alfa-2b and Ribavirin Therapy in Subjects With Type C Compensated Liver Cirrhosis (Study P05116)

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

The objective is to evaluate the efficacy and safety of combination therapy with peginterferon alfa-2b 1.0 µg/kg/week subcutaneous (SC) + ribavirin administered for 48 weeks in participants with chronic hepatitis C and type C compensated liver cirrhosis. Participants who are hepatitis C virus ribonucleic acid (HCV-RNA) positive after 24 weeks of treatment will be discontinued from therapy.

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: 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.