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Trial record 100 of 115 for:    "Viral Infectious Disease" | "Ledipasvir"

Impact of Antiviral Therapy on Gastroesophageal Varices.

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ClinicalTrials.gov Identifier: NCT02758509
Recruitment Status : Completed
First Posted : May 2, 2016
Last Update Posted : May 21, 2018
Sponsor:
Information provided by (Responsible Party):
José Antonio Carrion, Parc de Salut Mar

Brief Summary:
Hepatitis C virus (HCV) chronic infection affects 200 million people worldwide. HCV antiviral treatment has evolved rapidly since 2011. The use of pegylated interferon (PEG-INF) with ribavirin (RBV) has supposed high serious adverse events (SAEs) and low efficacy, especially in patients with cirrhosis. The introduction of 1st generation protease inhibitors (PIs) in genotype-1 (GT1) HCV, such as boceprevir (BOC) and telaprevir (TVR), improved the efficacy but increased the SAEs. Currently, interferon-free direct-acting antivirals (IF-DAAs) achieve great effectiveness with minimum SAEs. However, studies evaluating efficacy and safety of DAAs in cirrhotic patients are limited in real clinical practice. The aim of our study is to evaluate in HCV-cirrhotic patients the efficacy and safety of 3 treatment strategies (PEG-IFN/RBV, PEG-IFN/RBV/PIs, and IF-DAAs) in routine practice according to European guidelines from 2010 to 2015. The secondary aim is to evaluate the impact of sustained virological response on gastroesophageal varices (GOV).

Condition or disease Intervention/treatment
Chronic Hepatitis C Cirrhosis Drug: Pegylated interferon alfa-2a + Ribavirin Drug: Pegylated interferon alfa-2a + Ribavirin + Boceprevir Drug: Pegylated interferon alfa-2a + Ribavirin +Telaprevir Drug: Ledipasvir/Sofosbuvir Drug: Ombitasvir/paritaprevir/ritonavir+Dasabuvir Drug: Daclatasvir+Sofosbuvir Drug: Simeprevir+Sofosbuvir

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Study Type : Observational
Actual Enrollment : 237 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Efficacy and Safety of Interferon Based Therapy and Interferon-free Direct-acting Antivirals in Cirrhotic Patients With Hepatitis C. Impact of Antiviral Therapy on Gastroesophageal Varices.
Study Start Date : January 1, 2010
Actual Primary Completion Date : June 15, 2017
Actual Study Completion Date : October 15, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
PEG/RBV
Pegylated interferon alfa-2a 180 microg/week plus ribavirin 800-1200 mg during 48 weeks according to routine practice and European Guidelines (EASL recommendations 2011)
Drug: Pegylated interferon alfa-2a + Ribavirin
PEG/RBV+BOC or TVR
Boceprevir 800 mg/8h or Telaprevir 750 mg/8h plus Pegylated interferon alfa-2a 180 microg/week plus ribavirin 800-1200 mg during 48 weeks according to routine practice and European Guidelines (EASL recommendations 2014)
Drug: Pegylated interferon alfa-2a + Ribavirin + Boceprevir
Drug: Pegylated interferon alfa-2a + Ribavirin +Telaprevir
IF-DAAs

Interferon-free direct-acting antiviral combinations according to routine practice and European Guidelines (EASL recommendations 2015)

  • Fixed-dose combination of sofosbuvir (400 mg) and ledipasvir (90 mg) daily +/- ribavirin 12-24 weeks
  • Fixed-dose combination of ombitasvir (75 mg), paritaprevir (12.5 mg) and ritonavir (50 mg) in one single tablet (two tablets once daily) and dasabuvir (250 mg) (one tablet twice daily) with ribavirin 800-1200 mg 12 weeks (Genotype 1b) or 24 weeks (genotype 1a)
  • Daily sofosbuvir (400 mg) and daily simeprevir (150 mg) +/- ribavirin 12-24 weeks
  • Daily sofosbuvir (400 mg) and daily daclatasvir (60 mg) +/- ribavirin 12-24 weeks
Drug: Ledipasvir/Sofosbuvir
Drug: Ombitasvir/paritaprevir/ritonavir+Dasabuvir
Drug: Daclatasvir+Sofosbuvir
Drug: Simeprevir+Sofosbuvir



Primary Outcome Measures :
  1. sustained virological response (SVR) [ Time Frame: 12 weeks after treatment completion ]
    undetectable HCV viral load 12 weeks after the end of antiviral treatment in each cohort of antiviral treatment


Secondary Outcome Measures :
  1. Number of patients with gastroesophageal varices [ Time Frame: gastroesophageal varices (GOV) before antiviral treatment and 12-24 weeks after treatment completion ]
    Number of patients with GOV before and 12-24 weeks after treatment completion in patients with or without SVR



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with chronic hepatitis C by genotype 1 and liver cirrhosis
Criteria

Inclusion Criteria:

  • Age ≥ 18 years.
  • Signed informed consent.
  • Chronic hepatitis C (anti-HCV antibodies and detectable HCV-RNA).
  • Liver cirrhosis (transient elastography ≥ 14 kPa).
  • Baseline upper gastrointestinal endoscopy to assess gastroesophageal varices

Exclusion Criteria:

  • Negative to provide signed informed consent.
  • Negative to perform gastrointestinal endoscopy

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: José Antonio Carrion, PhD, Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT02758509     History of Changes
Other Study ID Numbers: PROGRESSIVE-C
First Posted: May 2, 2016    Key Record Dates
Last Update Posted: May 21, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Virus Diseases
RNA Virus Infections
Ledipasvir
Ledipasvir, sofosbuvir drug combination
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Flaviviridae Infections
Hepatitis, Chronic
Interferons
Ribavirin
Ritonavir
Interferon-alpha
Interferon alpha-2
Antiviral Agents
Sofosbuvir
Peginterferon alfa-2a
Simeprevir
Antineoplastic Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Anti-HIV Agents
Anti-Retroviral Agents