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Hepatitis clinical trials

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NCT ID: NCT01459913 Terminated - Clinical trials for Hepatitis C, Chronic

Efficacy of a 12-Week Regimen of Telaprevir, Pegylated Interferon, and Ribavirin in Treatment-Naive and Prior Relapser Subjects With Interleukin28B (IL28B) CC Genotype

CONCISE
Start date: November 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate if a 12-week total regimen of telaprevir in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV) (T12/PR12) is safe and effective in subjects who have the interleukin-28B (IL28B) CC genotype. The subjects enrolled in this study will have chronic hepatitis C virus (HCV) infection and will not have cirrhosis of the liver.

NCT ID: NCT01446250 Terminated - Hepatitis C Clinical Trials

Study of DEB025/Alisporivir Plus Pegylated Interferon alfa2a and Ribavirin and Boceprevir Plus Pegylated Interferon alfa2a and Ribavirin in African American Chronic Hepatitis C Genotype 1 Patients That Have Never Received Treatment for Their Hepatitis C

Start date: December 2011
Phase: Phase 3
Study type: Interventional

This study will assess the safety and efficacy of alisporivir plus pegylated interferon alfa2a and Ribavirin as well as boceprevir plus pegylated interferon alfa2a and Ribavirin in African American chronic hepatitis C genotype 1 patients that have never received treatment for their hepatitis C.

NCT ID: NCT01443923 Terminated - HIV/AIDS Clinical Trials

Boceprevir Drug Combination for Hepatitis C Treatment in People With and Without HIV

Start date: September 2011
Phase: Phase 4
Study type: Interventional

Background: - Standard treatment for the hepatitis C virus (HCV) is a combination of the drugs peg-IFN and ribavirin. However, this treatment is not very effective in people with a serious type of HCV (HCV genotype 1) and also in people who have human immunodeficiency virus (HIV) coinfection. Researchers want to add a new drug, boceprevir to see if it can improve treatment results in people with both HCV genotype 1 and HIV. Boceprevir used in combination with peg-IFN and ribavirin has been recently approved for the treatment of people with HCV genotype 1 infection only, and is currently being studied in those with HIV and HCV. Objectives: - To test boceprevir, peg-IFN, and ribavirin as a treatment for HCV genotype 1 in people with HCV monoinfection compared to those with both HIV and HCV infections. Eligibility: - Individuals at least 18 years of age who have HCV genotype 1 infection, and have not received interferon treatment for HCV - Half of the study participants will also have HIV infection. Design: - Participants will be screened with a medical history and physical exam. They will also have blood and urine tests. - Participants will also have heart and liver function tests, and answer questions about mood and depression. - Those in the study will receive ribavirin tablets to take twice a day, and peg-IFN to inject under the skin weekly. - Two weeks after starting treatment, participants will have blood tests to study the treatment. - Four weeks after starting treatment, participants will start taking boceprevir three times a day. - Participants will have regular study visits with blood samples and other tests. The length of therapy will depend on the level of virus detected in the blood at several clinic visits. Those who do not respond well to the medicines at 12 weeks will stop treatment. The full length of treatment is 48 weeks.

NCT ID: NCT01440595 Terminated - Clinical trials for Hepatitis C, Chronic

Grazoprevir (MK-5172) With Peg-Interferon and Ribavirin in Participants With Chronic Genotype 2 or 3 Hepatitis C (MK-5172-012)

Start date: November 28, 2011
Phase: Phase 2
Study type: Interventional

This study will evaluate the safety, tolerability, and antiviral activity of grazoprevir (MK-5172) when administered concomitantly with peg-interferon alfa-2b (Peg-IFN) and ribavirin (RBV) to treatment-naïve participants with chronic genotype 2 (GT2) or genotype 3 (GT3) hepatitis C virus (HCV) infections.

NCT ID: NCT01433133 Terminated - Hepatitis C Clinical Trials

Safety and Biological Activity of InfraDure Biopump Secreting Sustained Interferon in HCV Patients

Start date: October 2012
Phase: Phase 1/Phase 2
Study type: Interventional

This will be a Phase I-II, open-label, single center, uncontrolled, dose-escalation study. The trial will be conducted in Israel at the Tel Aviv Sourasky Medical Center. All subjects will receive autologous InfraDure Biopump (micro-organ of dermis processed ex vivo transduced with genetic construct containing the gene for interferon)tissue implants intended to provide sustained production and delivery of therapeutic levels of INF for up to twenty four (24) weeks following INFRADURE Biopump implantation. Follow up will continue for a total of two years post INFRADURE Biopump implantation

NCT ID: NCT01425190 Terminated - Clinical trials for Hepatitis C, Chronic

Pharmacokinetics of Boceprevir in Pediatric Subjects With Chronic Hepatitis C Genotype 1 (P07614)

Start date: January 4, 2012
Phase: Phase 1
Study type: Interventional

This is a study to determine the pharmacokinetics (PK) and weight-based dose of boceprevir following single oral dose administration in Chronic Hepatitis C Virus (HCV) pediatric participants.

NCT ID: NCT01406704 Terminated - Clinical trials for NASH (Non-alcoholic Steato-hepatitis)

Effects of Rosiglitazone and Alpha-lipoic Acid on the Patients With Pathologically Proved NASH

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

This study is to evaluate the effects of Rosiglitazone, insulin sensitizer and alpha-lipoic acid, antioxidant on patients with pathologically proved NASH (non-alcoholic steato-hepatitis).

NCT ID: NCT01391117 Terminated - Hepatitis C Virus Clinical Trials

TMC649128HPC1002 - a Trial inGenotype 1 Hepatitis C Virus (HCV) - Infected Participants to Determine the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of TMC649128, Alone and Combined With Pegylated Interferon + Ribavirin

Start date: June 2011
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine in genotype 1 Hepatitis C Virus (HCV)-infected participants, the safety, tolerability, pharmacokinetics (how the drug is absorbed in the body, how it is distributed within the body and removed from the body over time) and antiviral activity of repeated doses of TMC649128 given as monotherapy and given in combination with pegylated interferon + ribavirin. We assess the pharmacokinetic/pharmacodynamic (how the study medication affects the body) (PK/PD) relationship for antiviral activity, active metabolite and safety of TMC649128 and its metabolites. We determine the short term safety and tolerability of the co-administration of TMC649128 and pegylated interferon + ribavirin during multiple dosing for 14 days in treatment-naive genotype 1 HCV-infected participants. We explore the effect of pegylated interferon + ribavirin on the pharmacokinetics of TMC649128 during the multiple dosing for 14 days in treatment-naive genotype 1 HCV-infected participants. We also assess in a preliminary way the short term antiviral effect of the combination of TMC649128 with pegylated interferon + ribavirin during a 14-day dosing period in treatment-naive genotype 1 HCV-infected participants.

NCT ID: NCT01387958 Terminated - Hepatitis C Clinical Trials

A Two Week Dosing Study to Determine the Safety and Antiviral Activity of LCQ908 in Hepatitis C Patients

Start date: July 2011
Phase: Phase 2
Study type: Interventional

This is a proof of concept study, designed to look at the safety and antiviral activity of LCQ908 in hepatitis C infected patients.

NCT ID: NCT01384383 Terminated - Chronic Hepatitis C Clinical Trials

GS-5885, GS-9451 With Peginterferon Alfa 2a (PEG) and Ribavirin in Treatment-Naïve Subjects With Chronic Genotype 1 Hep C Virus Infection and IL28B CC Genotype

Start date: August 2011
Phase: Phase 2
Study type: Interventional

This is a Phase 2, randomized, open-label exploratory study that will examine the antiviral efficacy, safety, and tolerability of Response guided treatment (RGT) with GS-5885 + GS-9451 + PEG/RBV (6 or 12 weeks), or Peginterferon Alfa 2a (PEG)/Ribavirin (RBV)alone (24 weeks) in treatment naïve subjects with chronic Hep C (HCV) infection with genotype (GT) 1 and IL28B CC genotype.