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Hepatitis C, Chronic clinical trials

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NCT ID: NCT01425203 Completed - Clinical trials for Chronic Hepatitis C Genotype 1

The Effect of Boceprevir in Russian Participants Diagnosed With Chronic Hepatitis C Genotype 1 (P08160)

Start date: November 23, 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether Boceprevir (BOC, SCH 503034, MK-3034) in combination with Peginterferon Alfa 2-b (PEG) plus Ribavirin (RBV) [PEG+RBV=PR] is effective in the treatment of chronic hepatitis C (CHC) genotype 1 among the Russian population. The primary hypothesis is that the percentage of participants achieving sustained virologic response in the BOC + PR group is superior to that in the Placebo (PBO) + PR group.

NCT ID: NCT01425190 Terminated - Clinical trials for Hepatitis C, Chronic

Pharmacokinetics of Boceprevir in Pediatric Subjects With Chronic Hepatitis C Genotype 1 (P07614)

Start date: January 4, 2012
Phase: Phase 1
Study type: Interventional

This is a study to determine the pharmacokinetics (PK) and weight-based dose of boceprevir following single oral dose administration in Chronic Hepatitis C Virus (HCV) pediatric participants.

NCT ID: NCT01416610 Completed - Clinical trials for Hepatitis C, Chronic

An Observational Study of Pegasys (Peginterferon Alfa-2a) Plus Copegus (Ribavirin) in Participants With Chronic Hepatitis C (CHC), Genotype 2, 3, 1 or 4, Undergoing Opioid Maintenance Therapy

PEGHOPE
Start date: April 2010
Phase: N/A
Study type: Observational

This prospective, multi-center, observational study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) plus Copegus (ribavirin) in participants with previously untreated chronic hepatitis C, genotype 2, 3, 1 or 4, who are undergoing opioid maintenance therapy. Data will be collected from eligible participants receiving Pegasys and Copegus treatment as prescribed by treating physician and treatment-free follow-up period of 24 weeks.

NCT ID: NCT01413360 Recruiting - Chronic Hepatitis C Clinical Trials

The Effect of High Dose Vitamin C on the Liver Function in Chronic Hepatitis Patients

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

The investigators will evaluate the efficacy of high dose vitamin C in chronic hepatitis patients whose serum liver enzymes are elevated more than upper limit.

NCT ID: NCT01405937 Completed - Clinical trials for Hepatitis C, Chronic

Study of Vaniprevir Plus PegIntron®/Ribavirin in Japanese Participants With Chronic Hepatitis C Who Relapsed After Treatment (MK-7009-044)

Start date: August 29, 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, and efficacy of vaniprevir given in combination with pegylated interferon alfa-2b (PegIntron®/peg-IFN) and ribavirin (RBV) in chronic hepatitis C (CHC) Genotype I (GT 1) participants who relapsed after previous therapy with interferon-based therapy. The primary efficacy hypothesis is that the percentage of participants achieving sustained virologic response 24 weeks after completion of all study therapy (SVR24) in at least one of the vaniprevir 300 mg twice daily treatment regimens is greater than 20% (historical data of standard of care treatment).

NCT ID: NCT01405560 Completed - Clinical trials for Hepatitis C, Chronic

Vaniprevir Plus PegIntron®/Ribavirin in Japanese Participants With Chronic Hepatitis C Who Are Non-responders to Previous Treatment (MK-7009-045)

Start date: September 2, 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, and efficacy of vaniprevir (300 mg twice daily) given in combination with pegylated interferon alfa-2b (peg-IFN) and ribavirin (RBV) in Japanese participants with chronic hepatitis C (CHC) genotype (GT) 1 who have not responded to previous treatment. The primary efficacy objective is to estimate efficacy of vaniprevir, peg-IFN and RBV for 24 weeks as assessed by the percentage of participants achieving undetectable Hepatitis C Virus ribonucleic acid (HCV RNA) 24 weeks after completion of all study therapy (Sustained Viral Response 24 [SVR24]).

NCT ID: NCT01405027 Completed - Chronic Hepatitis C Clinical Trials

Impact of Physician Directed Education on Patient Compliance With Hepatitis C Therapy

OPTIMAL
Start date: December 2011
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the impact of a physician directed education program on treatment compliance of hepatitis C patients administered triple drug therapy of pegylated interferon, ribavirin and boceprevir.

NCT ID: NCT01403181 Completed - Chronic Hepatitis C Clinical Trials

Effect of Boceprevir on HCV-specific T Cell Responses

Boce-Par
Start date: April 2012
Phase: N/A
Study type: Observational

Analysis of HCV-specific T cell responses in patients treated with boceprevir to assess whether therapy can induce restoration of the T cell function and to what extent this recovery can be achieved

NCT ID: NCT01402583 Completed - Chronic Hepatitis C Clinical Trials

Menopause is a Critical Factor in Determining Failure of Antiviral Therapy in Women With Chronic Hepatitis C

MEN_EPID
Start date: July 2011
Phase: N/A
Study type: Observational

Menopause represents a critical period in a woman's life as the hormonal changes and the failing ovarian function not only determine relevant modifications in the reproductive function but also in many other conditions and organs that apparently are scarcely linked with hormones. The PI's centre has among its main goals the treatment of chronic liver disease; in the last years, a increasing interest in gender-related issues has grown. Goal of this study is to verify the impact of menopause on response to antiviral therapy for CHC and in determining more severe fibrosis in comparison with age-matched men. To achieve this goal a database of all the PEG IFN/Ribavirin patients treated in the GI Unit of the University of Modena and Reggio Emilia in the last 7 years will be set up. Demographic, clinical and biochemical data as well data regarding the reproductive history, time, type, length of estrogen deprivation and of hormone-replacement therapy will be collected.

NCT ID: NCT01399619 Completed - Clinical trials for Hepatitis C, Chronic

Phase III Trial of BI 201335 (Faldaprevir) in Treatment Naive (TN) and Relapser Hepatitis C Virus (HCV)-Human Immunodeficiency Virus (HIV) Coinfected Patients (STARTverso 4)

Start date: September 2011
Phase: Phase 3
Study type: Interventional

the aim of this trial is to evaluate the efficacy and the safety of BI 201335 given for 12 or 24 weeks in combination with PegIFN/RBV given for 24-48 weeks, according to re-randomisation of Early Treatment Success (ETS) patients at 24 weeks to stop PegIFN/RBV or continue PegIFN/RBV until week 48. If no ETS, then PegIFN/RB for 48 weeks, in HCV treatment-naive or relapsers patients coinfected with HIV