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Hepatitis C, Chronic clinical trials

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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: NCT01700179 Completed - Clinical trials for Chronic Hepatitis C Infection

Evaluation of Safety, Tolerability, and Antiviral Activity of ACH-0143102 Plus Ribavirin In Treatment-naive Hepatitis C Virus Infection Genotype 1b Participants

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

The purpose of this study was to evaluate the safety, tolerability, and efficacy of 12 weeks of treatment with ACH-0143102 and ribavirin in genotype 1b (GT1b), treatment-naive, hepatitis C virus (HCV) participants.

NCT ID: NCT01691235 Withdrawn - Clinical trials for Chronic Hepatitis C Virus

SIMpill Medication Dispensing Device in the Treatment of HCV

SIMpill HCV
Start date: September 2012
Phase: N/A
Study type: Observational

Subjects are being asked to participate in this study because they have genotype 1 Hepatitis C Virus (HCV) and will be taking the standard of care drugs pegylated interferon, ribavirin, and telaprevir as part of their routine care. The purpose of this study is to see if the SIMpill automated pill dispensing device can help subjects take their medications at the times the doctor has instructed them to take it. The SIMpill device is an automated pill dispensing device that records a time stamp each time the device is opened and a dose of medication is taken. Physicians can download this data and generate a precise account of when you have taken your medication. In addition, if a dose is missed, the SIMpill device can be set to automatically notify you by text message if a dose is overdue. The Simpill device is a new way to keep track of when you take your HCV medications and will also help remind you when you forget to take a dose. In addition, this information will help your doctors understand how taking medication on time effects the success of the therapy.

NCT ID: NCT01687270 Completed - Clinical trials for Post Liver Transplant

Safety and Efficacy of Sofosbuvir and Ribavirin in Adults With Recurrent Chronic Hepatitis C Virus (HCV) Post Liver Transplant

Start date: November 2012
Phase: Phase 2
Study type: Interventional

This is an open-label, single-arm study of sofosbuvir (GS-7977) and ribavirin (RBV) in adults who have had a liver transplant which has become re-infected with hepatitis C. The treatment period is 24 weeks with up to 48 weeks of follow up. The total time in this study will last up to 72 weeks not including the screening visit.

NCT ID: NCT01686789 Completed - Clinical trials for Chronic Hepatitis C Virus

Randomized Controlled Open Label Trial of Peg Alpha 2a Interferon and Adjusted-dose of Ribavirin vs. Standard Therapy in the Treatment of Naive Chronic Hepatitis C Patients Infected With Genotype 4

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

The study aims to study the outcome of pharmacokinetics-adjusted dose ribavirin (plus pegIFN) on the SVR in chronic HCV patients.

NCT ID: NCT01685203 Completed - Clinical trials for Hepatitis C, Chronic

A Study 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

PEARL-I
Start date: August 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of co-administration of ABT-450 (also known as paritaprevir) with ritonavir (ABT-450/r) and ABT-267 (also known as ombitasvir) in adults with chronic hepatitis C virus infection.

NCT ID: NCT01684787 Completed - Chronic Hepatitis C Clinical Trials

Study to Evaluate the Treatment for Chronic Hepatitis C With Normal Transaminases in HIV Positive Patients

CONTRA
Start date: September 2006
Phase: Phase 4
Study type: Interventional

In the current practice patients with normal levels of ALT were not treated. However, a percentage of patients will present an advanced grade of fibrosis and cirrhosis. Another reason to treat is the similar response to the treatment than elevated ALT patients published recently in mono-infected patients. The investigators have not data concerning the evolution and response to the treatment in co-infected patients with normal ALT. In the story of treatment chronic hepatitis C of co-infected patients HCV/HIV, sometimes, it assumes a behavior similar between mono and co-infected patients and the results are different. In the case of normal ALT the investigators do not know if the natural history in co-infected patients is similar than the mono-infected patients, and also the response of the treatment. This study prospective and controls is the answer of this question. The main hypothesis is if the response of treatment in co-infected patients is not inferior than mono-infected patients. The objective is to evaluate the efficacy and safety of peginterferon alfa-2a and ribavirin in HIV positive patients with chronic hepatitis and persistently normal ALT. Every CASE (patient with normal ALT) will have a CONTROL (patient with elevated ALT), concerning genotype, gender and hospital.

NCT ID: NCT01679834 Completed - Clinical trials for Hepatitis C, Chronic

An Observational Study of Pegasys in Dual- or Triple-Therapy in Patients With Chronic Hepatitis C

Start date: November 24, 2014
Phase: N/A
Study type: Observational

This multicenter, observational study will assess the efficacy and the safety of Pegasys (peginterferon alfa 2a) in dual- or triple therapy in patients with chronic hepatitis C. Patients will receive Pegasys and/or ribavirin and/or a protease inhibitor according to local guidelines. Data will be collected for 96 weeks.

NCT ID: NCT01678131 Completed - Chronic Hepatitis C Clinical Trials

Evaluating Fine Needle Aspiration to Measure Hepatic Vaniprevir (MK-7009) Concentrations in Participants With Chronic Hepatitis C (MK-7009-048)

Start date: October 30, 2012
Phase: Phase 1
Study type: Interventional

This study will evaluate the technical feasibility of using fine needle aspiration (FNA) of liver tissue to obtain vaniprevir (MK-7009) liver pharmacokinetic (PK) data, working towards identifying a minimally invasive, reproducible platform to measure liver PK. The study will be done in 2 parts. In Part 1, participants will be randomized to one of five FNA/core needle biopsy (CNB) time-point collection sequences. In Part 2, participants will be randomized to one of two possible doses of vaniprevir and will be assigned to one of five FNA/CNB time-point collection sequences; participants in Part 2 will also receive background therapy with pegylated interferon alpha-2b (Peg-IFN alpha-2b) and ribavirin (RBV). The primary hypothesis is that there is a greater than 80% posterior probability that vaniprevir concentrations are successfully obtained at least 60% of the time from FNA liver samples collected at 2 of 3 specified timepoints.

NCT ID: NCT01675427 Completed - Clinical trials for Hepatitis C, Chronic

A Study on the Correlation Between Interleukin 28B Genotypes With Clinical and Demographic Characteristics in Treatment-Naïve and Treatment-Experienced Patients With Chronic Hepatitis C

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

This multicenter study will evaluate the correlation of interleukin 28B (IL28B) genotypes with disease characteristics and demographics in treatment-naïve and treatment-experienced chronic hepatitis C patients, including patients with HIV co-infection. There will be a single study visit for testing.