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Hepatitis, Chronic clinical trials

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NCT ID: NCT01641666 Withdrawn - Chronic Hepatitis C Clinical Trials

Safety and Tolerability of Boceprevir in Combination With Peginterferon Alfa-2b Plus Ribavirin for the Treatment of Vietnamese Subjects With Chronic Hepatitis C Genotype 1 (P08599)

Start date: May 2014
Phase: Phase 3
Study type: Interventional

This study is designed to assess the safety and tolerability of boceprevir dosed 800 mg three times daily (TID) orally (PO) in combination with Peginterferon alfa-2b (PEG2b) 1.5 mcg/kg once a week (QW) administered subcutaneously (SC) plus ribavirin (RBV) (800 to 1400 mg/day) PO in Response Guided Therapy (RGT) in adult Vietnamese subjects with Chronic Hepatitis C, Genotype 1 (CHC GT1) who failed prior treatment with any interferon and ribavirin in Vietnam.

NCT ID: NCT01629732 Withdrawn - Hepatitis C Virus Clinical Trials

Phase 2b Study of BMS-986094 and Daclatasvir, With or Without Ribavirin for the Treatment of Patients With Chronic Hepatitis C

Start date: March 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the effectiveness of BMS-986094 and Daclatasvir (DCV) when given in combination with or without Ribavirin

NCT ID: NCT01608737 Withdrawn - Clinical trials for Hepatitis C, Chronic

A Phase III Study of BI201335 in Treatment-naive and Prior Relapser Patients With Chronic Hepatitis C Infection

Start date: September 2012
Phase: Phase 3
Study type: Interventional

The objectives of this study are: 1. To evaluate the efficacy and safety of two different treatment regimens with BI 201335 (high dose given for 12 weeks or low dose given for 24 weeks both in combination with Pegylated interferon-a and Ribavirin (PegIFN/RBV) as compared to PegIFN/RBV alone in treatment-naïve (TN) chronic genotype 1 hepatitis C virus infected patients. 2. Evaluate the efficacy and the safety of BI 201335 high dose given for 12 weeks in combination with PegIFN/RBV given for 24 to 48 weeks as compared to PegIFN/RBV alone in chronic GT-1 hepatitis C virus infected relapser patients who failed a prior PegIFN/RBV treatment.

NCT ID: NCT01590225 Withdrawn - Chronic Hepatitis C Clinical Trials

Efficacy and Safety of Boceprevir in Combination With Peginterferon Alfa-2b Plus Ribavirin in Pediatric Subjects With Chronic Hepatitis C Genotype 1 (P08034)

Start date: January 28, 2013
Phase: Phase 3
Study type: Interventional

This is a three-part (Part A, Part B, and Part C), open-label, multicenter study of boceprevir in pediatric participants with chronic hepatitis C (CHC) genotype 1 (GT1). In Part A and Part B, efficacy and safety will be evaluated in participants with CHC GT1 who are non-cirrhotic, treatment naïves (Part A) or who are non-cirrhotic, treatment failures to (peg)interferon/ribavirin or who are cirrhotics (whether treatment naïve or treatment failure) (Part B). Part C is long-term follow up and no study treatment will be administered during this period, but participants who do not achieve viral clearance will be allowed to receive other treatments for CHC.

NCT ID: NCT01547312 Withdrawn - Chronic Hepatitis C Clinical Trials

Evaluation of Hepatic Pharmacokinetics for Grazoprevir (MK-5172) in Participants With Chronic Hepatitis C (MK-5172-022)

Start date: May 2012
Phase: Phase 1
Study type: Interventional

This study is divided into 2 segments, and proposes to qualify fine needle aspiration (FNA) as a platform to evaluate the hepatic pharmacokinetics of low and high oral doses of Grazoprevir (MK-5172) in non-cirrhotic participants chronically infected with hepatitis C virus (HCV). The first segment, is a procedural pilot conducted prior to the main study, that is aimed at ensuring optimal execution of the FNA procedure. During the procedural pilot, core needle biopsy (CNB) will be performed on participants as part of their standard of care, but no study drugs will be administered, nor will any procedures other than FNA be conducted. The second segment, the main study, is designed to evaluate the feasibility of measuring Grazoprevir by FNA. During the main study, drugs will be administered, and other additional procedures will be conducted.

NCT ID: NCT01525212 Withdrawn - Chronic Hepatitis C Clinical Trials

Multiple Ascending Dose Study of BMS-929075 in Hepatitis C Virus (HCV) Infected Patients

Start date: April 2012
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the change from baseline in HCV Ribonucleic acid (RNA) on Day 4 following three days of dosing with BMS-929075 in chronically genotype subtype 1a and 1b HCV infected subjects

NCT ID: NCT01517308 Withdrawn - Chronic Hepatitis C Clinical Trials

24 VS 48-WEEK TREATMENT WITH PEG-IFN ALPHA-2A IN PATIENTS WITH GENOTYPE 2/3 CHRONIC HEPATITIS C

Start date: May 2012
Phase: Phase 3
Study type: Interventional

Aim of the present study is to evaluate in a cohort of patients with genotype 2/3 chronic hepatitis C, relapsers to a previous PEG-IFN + ribavirin therapy (alpha-2a or alpha-2b) the efficacy of PEG-IFNα-2a + ribavirin administered for 24 or 48 weeks. It will be evaluated whether 48 weeks of therapy may achieve better results compared to the standard duration (24 weeks).

NCT ID: NCT01296971 Withdrawn - Clinical trials for Hepatitis C, Chronic

A Study of the Safety of Individualized Combination Therapy With Copegus (Ribavirin) and Pegasys (Peginterferon Alfa-2a) in Patients With Chronic Hepatitis C (MASTER)

Start date: December 2009
Phase: Phase 3
Study type: Interventional

This open-label, non-comparative study will assess the safety and tolerability of individualized combination therapy with Copegus (ribavirin) and Pegasys (peginterferon alfa-2a) in patients with chronic hepatitis C. Patients with hepatitis C virus (HCV) genotype 1 (Group A) will receive Copegus 1'000 mg or 1'200 mg daily orally for 24-72 weeks. For patients with genotype 2 or 3 HCV (Group B) the Copegus dose will be 800 mg daily for 16-48 weeks. Patients who had previously received standard or pegylated interferons but were non-responders or with relapse (Group C) will receive Copegus 1'000 mg or 1'200 mg daily for up to 72 weeks. Concomitant therapy with Pegasys 180 mcg subcutaneously weekly will be given to all patients. Anticipated time on study treatment is up to 72 weeks with a 24-week follow-up.

NCT ID: NCT01274013 Withdrawn - Chronic Hepatitis C Clinical Trials

Vitamin D Deficiency in Subjects With Chronic Hepatitis C Compared to Healthy Volunteers

Start date: October 2009
Phase:
Study type: Observational

The objective of this study is to assess the prevalence of vitamin D deficiency in patients with chronic Hepatitis C compared to a matched control group of healthy individuals in the Sioux Falls area. It is the hypothesis of this study that vitamin D deficiency is more common in patients with chronic Hepatitis C compared to the healthy control group.

NCT ID: NCT01260610 Withdrawn - Chronic Hepatitis B Clinical Trials

Randomized Controlled Study of Tenofovir Plus Telbivudine Versus Monotherapy With Either Drug in HBeAg Negative Chronic Hepatitis B Patients

Start date: June 2011
Phase: N/A
Study type: Interventional

Combination therapies using nucleos(t)ide analogues lead to higher viral suppression although it may not be sustained for long. Also it remains unknown if combination of more potent analogues is more beneficial than individual drugs. Thus this study is carried out to determine the efficacy and safety of combination of tenofovir plus telbivudine (two most potent nucleos(t)ide analogues)versus monotherapy with either drug alone. This is a 104 week open labelled, prospective, randomized, multicentric study. The patient will receive either tenofovir, telbivudine or the combination of two drugs. After completion of 24 weeks, the non-responders (ie HBV-DNA > 300 copies/ ml) will be switched to combination arm and will continue receiving tenofovir plus telbivudine for 104 weeks.