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Hepatitis C clinical trials

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NCT ID: NCT01924949 Completed - Hepatitis C Clinical Trials

Ledipasvir/Sofosbuvir Fixed-Dose Combination in Adults With Nosocomial Genotype 1 HCV Infection

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

This study is to evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in adults with nosocomial genotype 1 hepatitis C virus (HCV) infection.

NCT ID: NCT01921400 Completed - Hepatitis C Clinical Trials

The Pathogenesis of Hepatitis C Virus Vertical Transmission

Start date: January 2013
Phase:
Study type: Observational

To evaluate for the presence of HCV Core protein, HCV RNA and SPP in the placenta and fetal membranes using paraffin-embedded sections and post-delivery specimens respectively. In parallel, we will assess placental tissue for evidence of HCV infection using a novel in situ hybridization technique and translate our in vitro findings to these in vivo samples. Our overall hypothesis is that cytotrophoblasts at the maternal-fetal interface within the placenta serve as a "barrier" that must be crossed during vertical transmission and that cytotrophoblasts are permissive to HCV at a low level that may be enhanced under certain conditions. By comparing the regulation of key steps in the intracellular life cycle of HCV in cytotrophoblasts to highly permissive hepatocytes, significant differences in HCV regulation should be revealed. Based on our preliminary data, our working hypothesis is that HCV Core protein is differentially processed in cytotrophoblasts compared to hepatocytes.

NCT ID: NCT01919125 Completed - Clinical trials for Hepatitis C, Chronic

Pharmacokinetics of IDX719 in Participants With Normal and Impaired Hepatic Function (MK-1894-008)

Start date: August 2013
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the pharmacokinetics (PK) and safety and tolerability of single-dose administration of IDX719 in participants with normal hepatic function and participants with varying degrees of hepatic impairment.

NCT ID: NCT01911845 Completed - Chronic Hepatitis C Clinical Trials

An Open-label, Single Arm, Phase 2 Study to Evaluate ABT-450/r/ABT-267 and ABT-333 With Ribavirin (RBV) in Adults With Genotype 1 HCV Infection Taking Methadone or Buprenorphine

Start date: April 2013
Phase: Phase 2
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 taking methadone or buprenorphine ± naloxone.

NCT ID: NCT01910636 Completed - Hepatitis C Clinical Trials

Efficacy and Safety of Sofosbuvir Plus Ribavirin in Japanese Adults With Chronic Genotype 2 HCV Infection

Start date: February 2013
Phase: Phase 3
Study type: Interventional

This study will evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) plus ribavirin (RBV) in Japanese participants with chronic genotype 2 hepatitis C virus (HCV) infection.

NCT ID: NCT01909804 Completed - Hepatitis C Clinical Trials

Safety and Efficacy of Sofosbuvir Plus Velpatasvir With or Without Ribavirin in Treatment-experienced Subjects With Chronic HCV Infection

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

The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) + velpatasvir (VEL; GS-5816) with or without ribavirin (RBV) in treatment-naive adults with chronic genotype (GT) 1 or 3 hepatitis C virus (HCV) infection.

NCT ID: NCT01909778 Completed - Hepatitis C Clinical Trials

Open Label Single Dose Phase I Trial of BI 201335 to Study Pharmacokinetics and Safety in Patients With Compensated Liver Cirrhosis

Start date: June 2008
Phase: Phase 1
Study type: Interventional

This trial was intended to investigate the pharmacokinetics, safety and tolerability of BI 201335 NA soft-gel capsules in patients with compensated liver cirrhosis, i.e. grade A according to Child-Pugh classification (< 7 points).

NCT ID: NCT01908660 Completed - Clinical trials for Hepatitis C, Chronic

Hepatic Safety of Currently Used Antiretroviral Regimens in Patients With Chronic Hepatitis Under Real Life Conditions

Start date: January 2007
Phase: N/A
Study type: Observational [Patient Registry]

The purpose of this study is to compare the liver toxicity in HIV-infected patients with chronic hepatitis B and/or hepatitis C, who start a new antiretroviral drug regimen, as well as the influence of the degree of pre-existing liver fibrosis on the incidence of liver toxicity.

NCT ID: NCT01908335 Completed - Chronic Hepatitis C Clinical Trials

A Phase Ⅱ Dose-escalating Study of PEG-IFN-SA and Ribavirin in IFN Naive Patients With Chronic Hepatitis C

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

This dose-escalating study is to evaluate the efficacy and the safety of different doses of a new bio-product Pegylated Recombinant Consensus Interferon Variant Solution for Injection (PEG-IFN-SA) and Ribavirin(RBV) in the treatment of Chronic hepatitis C who have not been previously treated with Interferon(IFN) by exploring the dose-effect relationship, while identity the optimal dose for phase Ⅲ study. In addition, population pharmacokinetic method is adopted to assess the pharmacokinetic behavior, individuals / intra-individual variability, and the possible factors for further study.

NCT ID: NCT01907724 Completed - Clinical trials for Hepatitis C, Chronic

Drug-Drug Interaction Between IDX719, Simeprevir, TMC647055 and Ritonavir When Administered in Combination in Healthy Participants (MK-1894-007)

Start date: May 2013
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the potential for a PK drug-drug interaction when IDX719, simeprevir, TMC647055 and low-dose ritonavir (RTV) are administered in combination. Safety and tolerability will also be assessed.