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Hepatitis clinical trials

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NCT ID: NCT01707849 Completed - Clinical trials for Hepatitis C Recurrence After Liver Transplant

The Impact of Everolimus Based Immunosuppression in the Evolution of Hepatitis C Fibrosis After Liver Transplantation

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

Background: Hepatitis C recurrence, which invariably occurs in viremic liver transplant (LT) recipients, associated with accelerated liver fibrosis leading to established graft cirrhosis in 40-20% of patients in 5 years with another 5% experiencing an aggressive form with cirrhosis and graft loss in 1 year. Since treatment after LT has a low efficacy, the overall survival of HCV-infected LT recipients is shorter than that of uninfected LT patients. New immunosuppressive agents such as mTOR inhibitors (Everolimus/Sirolimus) reduce the risk of liver graft rejection, have antifibrotic properties and do not worsen HCV recurrence. Moreover new directly-acting antiviral agents have increased efficacy of interferon-based treatment but their use in LT recipients may be limited by side effects. Hypothesis: Use of individualized immunosuppressive regimen and early personalized anti-viral treatment based on recipient and viral factors would improve outcome of HCV infected liver transplant recipients. Objectives: 1. To evaluate safety and efficacy of two steroid-free immunosuppressive regimens to reduce hepatitis C recurrence associated to fibrosis progression (F≥2 under ISHAK score) at one year post-transplant. 2. To identify viral and recipient factors associated with liver fibrosis progression using ultra-deep pyrosequencing (UDPS).

NCT ID: NCT01707472 Completed - HIV Clinical Trials

Study of Simtuzumab in HIV and/or Hepatitis C- Infected Adults With Liver Fibrosis

Start date: October 4, 2012
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to assess the safety and tolerability of simtuzumab (formerly GS-6624) in HIV and/or hepatitis C virus (HCV)-infected adults with evidence of liver fibrosis.

NCT ID: NCT01707030 Completed - Hepatitis C Clinical Trials

Web-based Intervention to Reduce Alcohol Use in Veterans With Hepatitis C

Start date: March 1, 2015
Phase: N/A
Study type: Interventional

Many people who are infected with Hepatitis C misuse alcohol, which is even more dangerous for them than it is for a non-infected person. In this VA study, such individuals will be screened and given feedback on their drinking using an Internet-based program which has been shown to reduce drinking in other populations. The research team will evaluate whether the program helps Veterans drink less over time and thereby improve their health.

NCT ID: NCT01706575 Completed - Clinical trials for Hepatitis B, Chronic

A Study of Pegasys (Peginterferon Alfa-2a) Added to Nucleos(t)Ide Analogue Treatment in Patients With HBeAg-Negative Chronic Hepatitis B Genotype D Showing Stable HBV DNA Suppression

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

This open-label, single-arm, multicenter study will evaluate the efficacy and safety of adding Pegasys (peginterferon alfa-2a) to nucleos(t)ide analogue (NAs) treatment in patients with HBeAg-negative chronic hepatitis B genotype D showing stable HBV DNA suppression. After a 12-week Lead-in period on treatment with NA, patients with a HBsAg decline <0.5 log10 IU/ml will enter the Add-on period to receive Pegasys 180 mcg subcutaneously weekly for 48 weeks in addition to their current NA treatment. Follow-up will be a further 48 weeks, during which the patients will continue their NA treatment.

NCT ID: NCT01705717 Completed - Clinical trials for Hepatitis C, Chronic

A Retrospective Study of Real World Treatment Outcomes of Patients With Chronic Hepatitis C

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

This retrospective, observational study will assess the real world treatment out comes in the management of patients with chronic hepatitis C. No prospective ass essment or procedure with patients during this study will be conducted. Data wil l be collected from patient medical records of the year 2000-2011.

NCT ID: NCT01705704 Completed - Clinical trials for Hepatitis B, Chronic

A Retrospective Biomarker Study of Stored Samples Obtained From Patients With Chronic Hepatitis B

Start date: June 2012
Phase: N/A
Study type: Observational

This retrospective study will evaluate the association of biomarkers and the treatment response of patients with chronic hepatitis B, who have completed therapy with Pegasys (peginterferon alfa-2a) ± lamivudine. For the analysis stored serum samples obtained from patients will be used; no actual patients are involved.

NCT ID: NCT01704755 Completed - Clinical trials for Chronic Hepatitis C Infection

A Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267; (ABT-267 Also Known as Ombitasvir) and ABT-333 (Also Known as Dasabuvir) Coadministered With Ribavirin (RBV) in Hepatitis C Virus (HCV) Genotype 1-infected Adults With Compensated Cirrhosis

TURQUOISE-II
Start date: October 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) coadministered with ribavirin (RBV) in hepatitis C virus (HCV) genotype 1-infected adults with compensated cirrhosis.

NCT ID: NCT01701401 Completed - Clinical trials for Chronic Hepatitis C Virus

Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination (FDC) With and Without Ribavirin for the Treatment of HCV

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

The purpose of this study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir (LDV)/sofosbuvir (SOF) fixed-dose combination (FDC) tablets with or without ribavirin (RBV) administered for 12 and 24 weeks in treatment-naive subjects with chronic genotype 1 HCV infection.

NCT ID: NCT01701336 Completed - Hepatitis C Clinical Trials

Study of a Novel Therapeutic Vaccine Against Hepatitis C Using Ad6NSmut and MVA-NSmut in Chronically Infected Patients

HCV004
Start date: March 2012
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine whether administration of recombinant IMPs Ad6NSmut and MVA-NSmut (experimental vaccines for hepatitis C) in HCV chronically infected patients in combination with the standard Interferon/ribavirin therapy is safe and induces an immunological response.

NCT ID: NCT01701063 Completed - Hepatitis C Clinical Trials

An Open-Label Study of the Effect of Telaprevir in Combination With Peginterferon Alfa-2b and Ribavirin in Pediatric Subjects Infected With Hepatitis C Virus

Start date: January 2013
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to assess the safety, efficacy, and pharmacokinetics in a carefully monitored cohort of pediatric subjects infected with HCV on a telaprevir-based regimen in Part A and with dose adjustments if needed before Part B.