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Hepatitis C, Chronic clinical trials

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NCT ID: NCT02123212 Completed - Hepatitis C Clinical Trials

Birth-Cohort Evaluation to Advance Screening and Testing for Hepatitis C

Best-C
Start date: February 2013
Phase: N/A
Study type: Interventional

The Birth-Cohort Evaluation to Advance Screening and Testing for Hepatitis C (BEST-C) compares the effectiveness of the birth cohort HCV screening strategy with the current risk-based screening approach to detect previous unidentified persons with viral hepatitis C who receive health care in primary systems. The study involved three clinical sites, The University of Alabama, Birmingham; The Henry Ford Health System; and the Mount Sinai Medical Center, each of which developed an independent intervention to experimentally compare the number of positive Hepatitis C Virus (HCV) diagnoses found using the birth-cohort screening approach with that found using traditional risk-based screening, or standard of care strategies. Birth cohort testing is defined as the systematic recommendation of HCV antibody testing to any persons born during the years of 1945 to 1965 who do not have clinically documented evidence of a prior antibody test without regards to the patient's stated risk of exposure to the virus.

NCT ID: NCT02120300 Completed - Clinical trials for Chronic HCV Infection

Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination and Sofosbuvir + Ribavirin for Subjects With Chronic Hepatitis C Virus (HCV) and Inherited Bleeding Disorders

Start date: April 2014
Phase: Phase 2
Study type: Interventional

This study will evaluate the antiviral efficacy, safety, and tolerability of treatment with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) for participants with genotypes 1 and 4 hepatitis C virus (HCV) infection and sofosbuvir (SOF) plus ribavirin (RBV) for participants with genotypes 2 and 3 HCV infection. Participants with an inherited bleeding disorder and chronic HCV infection (either monoinfected or HIV-1/HCV coinfected) will be enrolled.

NCT ID: NCT02118012 Completed - Chronic Hepatitis C Clinical Trials

Evaluation of Safety, Tolerability, and Antiviral Activity of Chlorcyclizine HCl in Patients With Chronic Hepatitis C

Start date: March 20, 2014
Phase: Phase 1/Phase 2
Study type: Interventional

Background: - Hepatitis C is a liver disease caused by the hepatitis C virus. It is the most common cause of serious liver disease in the United States. Many people have few if any symptoms. It can lead to cirrhosis, which can cause liver failure and cancer. Researchers want to study how a medicine called chlorcyclizine works in patients with hepatitis C. They want to see if it can be used to treat hepatitis C alone or when used with the standard hepatitis C treatment drug ribavirin. Objectives: - To see if chlorcyclizine can be used to treat hepatitis C alone or in combination with the drug ribavirin. Eligibility: - Adults with chronic hepatitis C who either have never been treated for it or have relapsed after prior treatment. Design: - Participants will be screened with medical history, physical exam, blood and urine tests, and a questionnaire. They will also have an ultrasound of their abdomen and electrocardiogram. Some of these tests will be repeated throughout the study. - Participants will spend 3 days as an inpatient to be monitored while starting study drug. They will be assigned randomly to a group and will begin taking the study drug. Blood will be taken frequently. - Group I will take the study drug twice a day for 28 days. - Group II will take the study drug twice a day and ribavirin twice a day for 28 days. - Participants will visit the clinic every 7 days for 28 days. - After participants stop taking the study drug, they will have 5 follow-up visits over 3 months.

NCT ID: NCT02115321 Completed - Chronic Hepatitis C Clinical Trials

Study of Efficacy and Safety of Grazoprevir (MK-5172) + Elbasvir (MK-8742) in Chronic Hepatitis C Participants With Child-Pugh (CP)-B Hepatic Insufficiency (MK-5172-059)

Start date: May 9, 2014
Phase: Phase 2/Phase 3
Study type: Interventional

This study is being done to evaluate the efficacy and safety of the drug combination grazoprevir (GZR; MK-5172) + elbasvir (EBR; MK-8742) in participants with chronic hepatitis C virus (HCV) genotype (GT) 1, 4, or 6 infection and who have cirrhosis and Child-Pugh (CP) score 7-9 moderate hepatic insufficiency (CP-B). The primary hypothesis is that the percentage of HCV-infected participants with hepatic insufficiency (the CP-B population) achieving sustained viral response (SVR) 12 weeks after the end of all treatment (SVR12) will be greater than 60%. Additionally, ten non-cirrhotic (NC) HCV-infected GT1 participants will also be given GZR + EBR at the beginning of the study; this will be done for the purpose of collecting plasma pharmacokinetic (PK) data in HCV GT1-infected participants who do not have hepatic insufficiency.

NCT ID: NCT02113631 Completed - Cirrhosis Clinical Trials

Comparative Effectiveness and Tolerability of Boceprevir vs Telaprevir

Start date: September 2011
Phase: N/A
Study type: Interventional

1. The primary objective is to study the comparative effectiveness and tolerability of boceprevir vs. telaprevir in HCV treatment, within the VA population. 2. The secondary objective: - Resource use: recording of differences in resource use, such as direct costs (e.g., drug acquisition costs) and other indirect cost (e.g., staff utilization etc.) as the study will not only derive data by comparing those two drugs but also study the effect on different treatment lengths.

NCT ID: NCT02106156 Completed - Chronic Hepatitis C Clinical Trials

Observational Study Evaluating the Quality of Pegasys and Copegus Treatment for Chronic Hepatitis C in Cooperation With the BNG (Association of German Resident Gastroenterologists)

Start date: January 2008
Phase: N/A
Study type: Observational

This observational study will examine the efficacy and safety of Pegasys (peginterferon alfa-2a), mostly in combination with Copegus (ribavirin) treatment in CHC patients. Quality of care will also be assessed. Approximately 12% of the interferon-treated chronic hepatitis C (CHC) patient population in Germany is expected to be studied over a period of 5 years.

NCT ID: NCT02105688 Completed - Chronic Hepatitis C Clinical Trials

An Efficacy and Safety Study of Grazoprevir (MK-5172) + Elbasvir (MK-8742) in the Treatment of Chronic Hepatitis C Virus (HCV) Genotype (GT)1, 4, or 6 Infection in Treatment-Naïve Participants Who Are on Opiate Substitution Therapy (MK-5172-062)

C-EDGE CO-STAR
Start date: September 2, 2014
Phase: Phase 3
Study type: Interventional

This is a 2-part study. The purpose of Part A is to assess the efficacy and safety of grazoprevir (MK-5172) 100 mg in combination with elbasvir (MK-8742) 50 mg for 12 weeks in the treatment of chronic HCV GT1, GT4, or GT6 infection in treatment-naïve participants who are on opiate substitution therapy (OST). The primary hypothesis is that the percentage of participants who receive grazoprevir/elbasvir fixed-dose combination (FDC) in the Immediate Treatment Arm and achieve a Sustained Virologic Response 12 weeks after the end of all study therapy (SVR12) will be superior to 67%. In addition, participants who received at least 1 dose of grazoprevir/elbasvir in Part A will be eligible to participate in Part B, which is a 3-year observational follow-up.

NCT ID: NCT02105662 Completed - Chronic Hepatitis C Clinical Trials

An Efficacy and Safety Study of Grazoprevir (MK-5172) + Elbasvir (MK-8742) in the Treatment of Chronic Hepatitis C Virus in Participants Who Are Co-Infected With Human Immunodeficiency Virus:C-EDGE CO-INFXN (MK-5172-061)

Start date: June 3, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of grazoprevir (MK-5172) 100 mg in combination with elbasvir (MK-8742) 50 mg in the treatment of chronic hepatitis C virus (HCV) in participants who are co-infected with human immunodeficiency virus (HIV). The primary hypothesis is that the percentage of participants who receive grazoprevir + elbasvir and achieve Sustained Virologic Response after 12 weeks of therapy (SVR12) will be greater than 70%.

NCT ID: NCT02105467 Completed - Clinical trials for Chronic Hepatitis C Virus

Study of Efficacy and Safety of Grazoprevir (MK-5172)/Elbasvir (MK-8742) Combination Regimen for Treatment-Naïve Participants With Chronic Hepatitis C Virus Genotypes 1, 4, and 6 (MK-5172-060)

Start date: June 5, 2014
Phase: Phase 3
Study type: Interventional

This was an efficacy and safety study of grazoprevir (MK-5172) in combination with elbasvir (MK-8742) in treatment-naive participants with chronic hepatitis C virus (HCV) genotype (GT) 1, 4, or 6 infection. Participants were randomly assigned (3:1 ratio) to immediate treatment or deferred treatment (placebo control). The primary efficacy hypothesis was that the proportion of participants receiving combination therapy in the Immediate Treatment Arm who achieve sustained viral response at 12 weeks after the end of study treatment (SVR12) is superior to 73%.

NCT ID: NCT02105454 Completed - Hepatitis C Virus Clinical Trials

Study of Grazoprevir (MK-5172) + Elbasvir (MK-8742) + Ribavirin in Participants With Chronic Hepatitis C Who Failed Prior Direct-Acting Antiviral Therapy (MK-5172-048)

Start date: May 23, 2014
Phase: Phase 2
Study type: Interventional

In this study, participants with hepatitis C virus (HCV) genotype 1 (GT1) who failed prior direct-acting antiviral (DAA) therapy will receive Grazoprevir (MK-5172) + Elbasvir (MK-8742) + Ribavirin (RBV) to evaluate sustained virologic response (SVR) using this drug combination.