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Ribavirin Clinical Trials
Listings Sponsored By:
Response-guided triple-therapy with boceprevir (BOC) in combination with pegylated interferon (PEGIFN) and ribavirin (RBV) is the current standard of care for HIV-negative patients infected with hepatitis C genotype (HCV-GT) 1. In contrast, in HIV-positive patients, a fixed treatment duration [more...] of 48 weeks is used. The aim of this study is to assess efficacy and safety of response-guided triple-therapy with BOC in combination with PEGIFN and RBV in HIV-positive patients. Thus, treatment duration will be individualized based on HCV-RNA negativity at treatment week 8 (W8). All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with undetectable HCV-RNA at W8 will be treated with 24 weeks of BOC/PEGIFN/RBV triple-therapy resulting in a total treatment duration of 28 weeks, while patients with detectable HCV-RNA at W8 will receive 44 weeks of BOC/PEGIFN/RBV triple-therapy and a total treatment duration of 48 weeks.
Status: Recruiting Start Date: August 2013 Completion Date:
Primary objective: • Develop and validate a tool towards patients with chronic hepatitis C genotype 1 and 4 to allow optimize treatment.
Status: Recruiting Start Date: October 2010 Completion Date: March 2015
The purpose of this open-label study is to assess the safety, tolerability, antiviral activity, genotype resistance associated with virological failure, pharmacokinetics and pharmacodynamics of two dose regimens of miravirsen in combination with telaprevir and ribavirin in subjects with hepatitis [more...] C virus genotype 1 infection who are null responder to pegylated-interferon alpha and ribavirin.
Status: Recruiting Start Date: June 2013 Completion Date: January 2015
The aim of this trial is to evaluate efficacy and safety of treatment with 600 mg of BID BI 207127 in combination with 120 mg QD Faldaprevir and RBV compared to a Telaprevir-based regimen along with PegIFN and RBV in chronically infected HCV GT1 [more...] treatment naïve patients, including patients with compensated cirrhosis.
Status: Recruiting Start Date: May 2013 Completion Date: May 2016
This study is designed to provide a preliminary assessment of the safety and effectiveness of the combination of PPI-668, BI 207127 and faldaprevir, with or without ribavirin, in the treatment of chronic hepatitis C virus infection.
Status: Recruiting Start Date: May 2013 Completion Date: May 2014
The purpose of this study is to evaluate the safety, tolerability, efficacy and pharmacokinetic profiles of IDX719 and simeprevir when administered in combination with ribavirin (RBV) for 12 weeks in treatment-naïve, Genotype 1b and Genotype 4 HCV-infected subjects.
Status: Recruiting Start Date: May 2013 Completion Date: May 2015
To evaluate the safety, tolerability and efficacy of 12 weeks of treatment with sovaprevir, ACH-3102 and ribavirin in GT1, treatment-naive, HCV subjects.
Status: Recruiting Start Date: April 2013 Completion Date: February 2015
Proof-of Concept, Open-Label, Two-Stage Study without Direct Individual Benefit The proposed study design consists of two treatment periods and one treatment arm. Treatment Period 1 involves the administration of RBV monotherapy for a period of 8 weeks and Treatment Period [more...] 2 involves administration of up to 16 weeks combination therapy with RBV plus HCQ.
Status: Recruiting Start Date: April 2013 Completion Date: July 2014
This is a study to evaluate the efficacy and safety of three experimental drugs compared with Telaprevir (a licensed product) in people with hepatitis C virus infection who have not had treatment before.
Status: Recruiting Start Date: March 2013 Completion Date: July 2015
The goal of this clinical research study is to learn if the antiviral combination of telaprevir, pegylated Interferon Alfa 2a (PegIFN alfa-2a) and ribavirin (RBV) can prevent the virus from coming back after the liver transplant. Telaprevir, PegIFN alfa-2a, [more...] and RBV are different antiviral drugs that work in combination at different stages of the HCV infection to stop the virus.
Status: Recruiting Start Date: April 2013 Completion Date:
Cohort A: Objective of Part 1a: to assess the pharmacokenetic characteristics of 600 mg BID BI 207127 / 120 mg QD faldaprevir /ribavirin in a small number of GT1b HCV infected patients with mild hepatic impairment (CPA) (Arm 1) versus 400 mg [more...] BID BI 207127 / 120 mg QD faldaprevir /ribavirin in a small number of GT1b HCV infected patients with moderate hepatic impairment (CPB) (Arm 2). Cohort A: Objective of Part 1b (Arm 3): Part 1b will only be conducted if the pharmacokenetics in Part 1a show that the 400 mg BID BI 207127 / 120 mg QD faldaprevir / ribavirin regimen is inadequate to achieve therapeutic BI207127 and/or faldaprevir levels. Part 1B will assess the pharmacokenetic characteristics of 600 mg BID BI 207127 / 120 mg QD faldaprevir /ribavirin in a small number of GT1b HCV infected patients with moderate hepatic impairment (CPB). If arm 2 in part 1a has similar or higher PK than Arm 1, Part 1b (Arm 3) will be skipped. Cohort B: Main Objective Part 2: To evaluate the safety, efficacy and PK of treatment with 120 mg of once daily (QD) faldaprevir for 24 weeks in combination with either 400 mg of twice-daily (BID) BI 207127 or 600 mg of BID BI 207127 (depending on the outcome of Part 1) and ribavirin (R) in a larger group of GT1b HCV infected patients with moderate hepatic impairment (CPB).
Status: Recruiting Start Date: April 2013 Completion Date: December 2016
The purpose of the study is to determine the safety, pharmacokinetics and efficacy of orally administered VX-135 with ribavirin in treatment naive subjects with chronic hepatitis C infection.
Status: Recruiting Start Date: February 2013 Completion Date: December 2014
The purpose of this study is to determine if 48 weeks of therapy with Peginterferon Lambda plus Ribavirin is effective and safe for a treatment of chronic hepatitis C (CHC) compared to therapy with Peginterferon alfa-2a plus Ribavirin.
Status: Recruiting Start Date: April 2013 Completion Date: September 2015
The primary objective for this study is to evaluate the proportion of subjects who achieve SVR12 (HCV RNA < LLOQ (target not detected) at post-treatment follow-up Week 12 in subjects with Genotype(GT)-1b, -4 and GT-2, -3
Status: Recruiting Start Date: March 2013 Completion Date: March 2017
The standard treatment of chronic hepatitis C infection is pegylated interferon alpha combined with ribavirin. Anaemia is a common complication occurring in up to 30% of subjects. Unfortunately, side effects of interferon and ribavirin therapy can require dose reductions, [more...] reducing the likelihood of sustained viral response. Recent data shows that interferon alpha may increase hepcidin (a key iron regulator) production, resulting in impaired iron availability for production of red blood cells. In this study, we will evaluate hepcidin levels in 30 patients with Hepatitis C who are treated with interferon containing regimes. If hepcidin plays a role in interferon-induced anaemia, cheap and readily available oral hepcidin inhibitors could be trialled to potentially reduce the impact of interferon alpha induced anaemia.
Status: Recruiting Start Date: December 2012 Completion Date: July 2014
The purpose of this study is to determine if treatment with Pegylated Interferon Lambda-1a, given in combination with Ribavirin and Daclatasvir for 24 weeks, is as safe and effective as the standard treatment with Pegylated Interferon Alfa-2a + Ribavirin + Telaprevir in [more...] subjects who are infected with Chronic Hepatitis C virus genotype 1b and have never received any prior anti-HCV treatment, or who have relapsed after an initial, successful treatment with Pegylated Interferon Alfa + Ribavirin
Status: Recruiting Start Date: January 2013 Completion Date: January 2015
This is a study of the safety and efficacy of MK-5172 in combination with MK-8742 ± ribavirin (RBV). Part A is being done in treatment-naïve (TN), genotype 1 (GT1), interferon eligible, non-cirrhotic (N-C) participants with chronic hepatitis C (CHC). Participants [more...] will be assigned randomly to 1 of 2 treatment arms in which they will receive MK-5172 100 mg once daily (QD) + MK-8742 20 mg or 50 mg QD and twice daily (BID) RBV, or to a treatment arm in which they will receive MK-5172 100 mg QD + MK-8742 50 mg QD without RBV. Treatment will last 12 weeks. In Part B, participants with hepatitis C virus (HCV) GT1 and HCV ribonucleic acid (RNA) levels of ≥10,000 IU/mL will be randomly assigned to a study arm, based on absence or presence of cirrhosis (C), whether they are TN or had poor response to previous antiviral therapy (null responders [NR]), or whether co-infected with human immunodeficiency virus (HIV); these participants will receive MK-5172 in combination with MK-8742 50mg ± RBV. Treatment will last 8 to 18 weeks dependent on arm assignment.
Status: Recruiting Start Date: February 2013 Completion Date: August 2014
The term Acute on chronic liver failure (ACLF) describes a clinical entity characterized by an acute and rapid deterioration of liver function in a patient with previously well-compensated liver disease owing to the effects of a precipitating event. In this [more...] condition two insults act simultaneously, one being the preexisting liver injury (chronic liver disease) and the other acute injury which is responsible for the acute decompensation. HEV being a major factor responsible for this clinical entity and has a very high mortality rate. Ribavirin being a safe drug and has been shown to inhibit the replication of HEV, can be an important drug in the treatment of these patients. Therefore the present study is designed to study the impact of Ribavirin in reducing the mortality due to HEV related ACLF.
Status: Recruiting Start Date: September 2012 Completion Date: June 2014
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.
Status: Recruiting Start Date: January 2013 Completion Date: May 2017
The purpose of this study is to explore the efficacy and safety of TMC647055, TMC435 and low-dose ritonavir, administered together, with and without ribavirin, in a limited number of chronically hepatitis C virus (HCV) infected patients.
Status: Recruiting Start Date: October 2012 Completion Date: August 2015
The purpose of this study is to evaluate the safety and effect of co-administration of ABT-450 with ritonavir (ABT-450/r) and ABT-267 in adults with chronic hepatitis C virus infection.
Status: Recruiting Start Date: August 2012 Completion Date: February 2015
The aim of the study is to investigate the treatment response of metformin, Peg-IFN and ribavirin combination therapy for chronic hepatitis C virus (HCV).
Status: Recruiting Start Date: August 2012 Completion Date: August 2014
The purpose of this study is to determine if 24 weeks of treatment with Pegylated Interferon Lambda plus Ribavirin and 12 weeks of treatment with Pegylated Interferon Lambda plus Ribavirin and Daclatasvir will be safe and effective for treatment of hepatitis C compared [more...] to 24 weeks of treatment with Pegylated Interferon Alfa-2a plus Ribavirin
Status: Recruiting Start Date: July 2012 Completion Date: November 2014
The purpose of this study is to determine whether Peginterferon Lambda-1a (Lambda) combined with Ribavirin (RBV) and Telaprevir (TVR) is effective in the treatment of chronic Hepatitis C (CHC) compared to Peginterferon Alfa-2a (alfa-2a) combined with RBV and Telaprevir.
Status: Recruiting Start Date: June 2012 Completion Date: October 2015
Patients are being asked to be part of this study because they are a liver transplant recipient and have the Hepatitis C Virus (HCV). Current routine treatment for HCV for liver transplant patients includes taking two medications called pegylated interferon [more...] alfa-2a (Pegasys®) and ribavirin. Patients Pegasys and ribavirin are FDA approved for the treatment of HCV. This study will evaluate the safety and efficacy of adding a third drug called telaprevir for the experimental treatment of HCV in liver transplant patients. The combination of Pegasys, ribavirin and telaprevir is currently FDA approved for the treatment of HCV, but is specifically not FDA approved for HCV patients who have had a liver transplant. This is because more information is needed about possible drug interactions between telaprevir and cyclosporine, or telaprevir and tacrolimus-based immunosuppressive drugs, which are typically part of routine care for transplant patients. Studies have shown that the addition of telaprevir greatly increases the efficacy of Pegasys and ribavirin for the treatment of HCV. However, these studies did not include adequate information on transplant patients due to the potential drug interactions. The investigators hope to gather more information about the safety and efficacy of telaprevir given in combination with Pegasys and ribavirin in the liver transplant patients who have HCV that is not well controlled with Pegasys and ribavirin alone.
Status: Recruiting Start Date: April 2012 Completion Date: April 2018
Clinical trials allow volunteers access to medical treatment options before they are available to the general public. Participants often receive the best healthcare available for their condition.
Risks are a reality, however, and may include more frequent doctor visits, health risks (possibly life-threatening), and/or the treatment being ineffective. Trials are federally regulated with strict guidelines to protect participants.
Ribavirin Clinical Trials Information presented on ClinicalTrialsSearch.org is not intended to be a substitute for qualified medical advice visit or treatment with a real physician. We are not physicians. Always consult with a medical doctor (MD). ClinicalTrialsSearch.org is a website dedicated to listing clinical research studies in human subjects, including those specifically related to Ribavirin. Clinical research trials and medical trials take place in hundreds of cities across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectiveness of new treatments and drugs. The purpose of the studies is to answer specific human health questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions. Clinical trials allow volunteers access to medical treatment options before they are available to the general public. Many times the participants receive treatment for free, and sometimes they are paid for their time. Participants often receive the best healthcare available possible for their condition. Risks are a reality, however, and may include more frequent doctor visits, health risks (possibly life-threatening), and/or the treatment being ineffective. U.S. - based Ribavirin studies are federally regulated with strict guidelines to protect patients.
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