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Hepatitis clinical trials

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NCT ID: NCT01226797 Terminated - Clinical trials for Hepatitis C, Chronic

Safety And Efficacy Of Oral PF-4136309 In Patients With Chronic Hepatitis C Infection And Abnormal Liver Enzymes

Start date: January 17, 2011
Phase: Phase 2
Study type: Interventional

This study will evaluate the effect of PF-04136309 in patients with chronic hepatitic C virus infection and abnormal liver enzymes.

NCT ID: NCT01217632 Terminated - Clinical trials for Liver Fibrosis Due to Chronic Hepatitis B Infection

A Study of FG-3019 in Subjects With Liver Fibrosis Due to Chronic Hepatitis B Infection

Start date: August 2010
Phase: Phase 2
Study type: Interventional

The overall goal of this trial is to evaluate the efficacy of FG-3019 for reversing liver fibrosis in subjects with chronic hepatitis B infection who are beginning antiviral therapy with entecavir. This Phase 2 randomized, double-blind, placebo controlled study will enroll subjects with chronic active hepatitis B infection and liver fibrosis (Ishak score ≥2) who are eligible for antiviral therapy.

NCT ID: NCT01182298 Terminated - HIV Clinical Trials

Open Label Study to Evaluate Chronic Hepatitis C Treatment in Latino Subjects With and Without HIV Co-infection

LATHCV
Start date: July 2010
Phase:
Study type: Observational

- Peginterferon alfa-2a has been approved by the U.S. Food and Drug Administration (FDA) to treat adults with chronic hepatitis C virus (HCV) infection with liver disease who have not been previously treated with interferon-alpha drugs (which improve immune system response to infection). Ribavirin has been approved by the FDA and is usually given in combination with interferon drugs such as peginterferon alfa-2a for treatment of chronic HCV. - Recent research shows that Latino whites do not respond as well to treatment with peginterferon alfa-2a and ribavirin as non-Latino whites. Various factors such as excessive weight, gender, and insulin resistance were evaluated to explain this difference, but research suggests that underlying factors related to Latino or non-Latino background, possibly genetic and immune differences, may be affecting the response to HCV infection and treatment. However, more research is needed on the effectiveness of peginterferon and ribavirin in Latino subjects with HCV, and with combined and human immunodeficiency virus (HIV) co-infection. Objectives: - To evaluate the safety, effectiveness, and viral response of peginterferon alfa-2a and ribavirin therapy for chronic hepatitis C in Latino participants with and without HIV co-infection. This is an observational study. The observed treatment is received and managed through their primary care.

NCT ID: NCT01168856 Terminated - Clinical trials for Hepatitis C, Chronic

An Observational Study on Long-Term Persistence of Resistant Mutations And Durability of Sustained Virological Response in Patients With Chronic Hepatitis C Treated With Direct Acting Antiviral (DAA)- Containing Regimens

Start date: September 2010
Phase: N/A
Study type: Observational

This observational long-term follow-up study will assess the persistence of direct acting antiviral (DAA) resistant mutations and the durability of sustained virological response in patients with chronic hepatitis C who have participated in a Roche DAA treatment protocol. Up to 5 scheduled monitoring visits for blood sampling during an observational period of up to 36 months.

NCT ID: NCT01153919 Terminated - Thrombocytopenia Clinical Trials

Romiplostim in Treating Hepatitis C-Infected Patients With Thrombocytopenia

Start date: June 30, 2010
Phase: Phase 2
Study type: Interventional

RATIONALE: Romiplostim may cause the body to make platelets. PURPOSE: This randomized phase II trial is studying how well romiplostim works in treating hepatitis C-infected patients with thrombocytopenia.

NCT ID: NCT01121185 Terminated - Clinical trials for Liver Transplantation

Study in Hepatitis C Virus (HCV) Infected Patients Undergoing Liver Transplantation to Evaluate a Human Monoclonal Antibody Against Hepatitis C

MBL-HCV1
Start date: June 2010
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether a human monoclonal antibody against Hepatitis C (MBL-HCV1) is effective in preventing detectable levels of Hepatitis C virus in patients undergoing liver transplantation due to chronic HCV infection. The study will also determine if MBL-HCV1 is effective in delaying or reducing the amount of detectable HCV in patients after transplant.

NCT ID: NCT01100749 Terminated - Clinical trials for Chronic Hepatitis C - Genotype 3

Chronic Hepatitis C (CHC) - Genotype 3 Infection in Canada

Start date: February 2010
Phase: N/A
Study type: Observational

Hepatitis C is a small RNA virus spread by blood to blood contamination. There are to date 6 known genotypes and within each there are several subtypes. Although all genotypes are distributed worldwide some are more common in certain countries and/or among certain populations.

NCT ID: NCT01095445 Terminated - Chronic Hepatitis C Clinical Trials

EXtended Therapy in Hepatitis C Genotype 3 Infected Patients

EXACT-R(3)
Start date: February 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effect of 48 vs 24 weeks of treatment with Peginterferon alfa-2b plus weight-based ribavirin on Sustained Virologic Response (SVR) and relapse rates in patients infected with genotype 3 chronic hepatitis C (CHC) who do not achieve a Rapid Virologic Response (RVR) but attain a complete Early Virologic Response (cEVR).

NCT ID: NCT01080222 Terminated - Clinical trials for Chronic Hepatitis C Virus Infection

A Safety and Efficacy Study of the Combination of VX-222 and Telaprevir in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Virus Infection

Start date: August 2010
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of combination treatment with VX-222 and telaprevir administered for 12 weeks with and without peginterferon-alfa-2a and/or ribavirin. The subjects enrolled in this study are chronically infected with hepatitis C virus (HCV) genotype 1 and will not have previously received treatment for their HCV infection. This study will include an Investigational Phase and Extension Phase. These phases will contain a Treatment Period and a Follow-up Period. All subjects will be enrolled in the Investigational Phase of this study. Subjects who fail treatment during the Investigational Phase will have the option to enter the Extension Phase at which point they will be eligible to receive peginterferon alfa-2a and ribavirin for a total of 48 weeks. Based on an evaluation of on-treatment safety, pharmacokinetic and antiviral data from patients in each arm of the trial, Vertex may elect to enroll up to two additional treatment arms (Treatment Arm E and Treatment Arm F) that will evaluate telaprevir/VX-222-based combination therapy. The components of the treatment regimens of these arms will be selected based on clinical data that emerges from the four initially-studied regimens. If enacted, up to 25 patients are expected to enroll in each additional treatment arm. If Treatment Arm E or Treatment Arm F is discontinued subjects meeting certain criteria will have the option to enter a telaprevir-containing Rollover Phase. Subjects who do not meet the eligibility criteria to enter the Rollover Phase may elect to enter the Extension Phase.

NCT ID: NCT01052090 Terminated - Clinical trials for Hepatitis C Virus Infection

Safety and Efficacy Study in Hepatitis C Patients With PHN121

ENCHAMP
Start date: September 2009
Phase: Phase 1/Phase 2
Study type: Interventional

To evaluate the safety, tolerability and efficacy of escalating dose of PHN121 when administered orally in non-responder hepatitis C genotype 1 patients