Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 80 of 115 for:    "Viral Infectious Disease" | "Ledipasvir"

Program of Screening, Prevention and Elimination of Hepatitis C in Penitentiary Institutions in Cantabria (JAILFREE-C) (JAILFREE-C)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02768961
Recruitment Status : Completed
First Posted : May 11, 2016
Last Update Posted : May 18, 2017
Sponsor:
Information provided by (Responsible Party):
Instituto de Investigación Marqués de Valdecilla

Brief Summary:

The objectives of this study are:

  1. To perform a systematic screening and evaluation of the prevalence of infection by hepatitis C virus (HCV), hepatitis B virus (HBV) and human immunodeficiency virus (HIV) in the prison population.
  2. To perform an adequate characterization of patients and the characteristics of HCV infection in this population.
  3. To evaluate the effectiveness and security in the prison population of an interferon-free antiviral regimen.
  4. To evaluate the impact of a strategy of systematic HCV treatment on the rates of persistent infection, reinfection and super-infection in a prison population, in the short, medium and long term.

Condition or disease Intervention/treatment Phase
Hepatitis C Drug: sofosbuvir Drug: ledipasvir Phase 4

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Program of Screening, Prevention and Elimination of Hepatitis C in Penitentiary Institutions in Cantabria. JAILFREE-C
Actual Study Start Date : May 10, 2016
Actual Primary Completion Date : May 10, 2017
Actual Study Completion Date : May 10, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Sofosbuvir

Arm Intervention/treatment
Experimental: Active treatment

All HCV chronic infected patients will be treated with oral anti-HCV regimens containing sofosbuvir, ledipasvir (associated or not to ribavirin) according to clinical practice as indicated into the current guidelines (1)

(1)European Association for Study of Liver (EASL). EASL Recommendations on Treatment of Hepatitis C 2015. J Hepatol. 2015 Jul;63(1):199-236. doi: 10.1016/j.jhep.2015.03.025. Epub 2015 Apr 21. PubMed PMID: 25911336.

Drug: sofosbuvir

Subjects will be treated according to the current guidelines on HCV treatment taking into account the stage of fibrosis, genotype, previous treatments, etc.

Sofosbuvir will be used in association with ledipasvir. In some cases, ribavirin can be added to this combination according to current guidelines

Other Name: Harvoni

Drug: ledipasvir

Subjects will be treated according to the current guidelines on HCV treatment taking into account the stage of fibrosis, genotype, previous treatments, etc.

Ledipasvir will be used in association with sofosbuvir. In some cases, ribavirin can be added to this combination according to current guidelines

Other Name: Harvoni




Primary Outcome Measures :
  1. Prevalence of chronic hepatitis C [ Time Frame: 12 months after the beginning of the study. ]
    Percentage of viremic hepatitis C patients with respect to the whole inmate population

  2. Percentage of Participants with Sustained Virological Response [ Time Frame: 12 weeks after the end of treatment ]
    Percentage of Participants with Sustained Virological Response (undetectable viral load) at this point


Secondary Outcome Measures :
  1. Adverse events [ Time Frame: 4 weeks after the start of treatment ]
    Presence and type of adverse events at this point.

  2. Adverse events [ Time Frame: 8 weeks after the start of treatment ]
    Presence and type of adverse events at this point.

  3. Adverse events [ Time Frame: 12 weeks after the start of treatment ]
    Presence and type of adverse events at this point.

  4. Adverse events [ Time Frame: 24 weeks after the start of treatment ]
    Presence and type of adverse events at this point.

  5. Percentage of Participants with Sustained Virological Response [ Time Frame: 4 weeks after the end of treatment ]
    Percentage of Participants with Sustained Virological Response (undetectable viral load) at this point

  6. HCV seroprevalence [ Time Frame: baseline ]
    Presence of anti-HCV at baseline

  7. HBV seroprevalence [ Time Frame: baseline ]
    Presence of HBsAg seropositivity

  8. HIV seroprevalence [ Time Frame: baseline ]
    Presence of anti-HIV at baseline

  9. Chronic HCV infection prevalence [ Time Frame: baseline ]
    Detectable HCV RNA viral load at baseline



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Epidemiology study: All inmates at the El Dueso Penitentiary Centre including new admissions within the study period.
  • Interventional study: All HCV infected patients with detectable viral load (HCV RNA)
  • Informed consent signature

Exclusion Criteria:

  • Not informed consent signature.
  • Pregnant or breastfeeding women
  • Hypersensitivity or any temporary or permanent absolute contraindication to either drug that should be prescribed according to clinical and virological characteristics of the patient.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02768961


Locations
Layout table for location information
Spain
Penitentiary "El Dueso". Cantabria. Spain
Santoña, Cantabria, Spain, 39740
Sponsors and Collaborators
Instituto de Investigación Marqués de Valdecilla
Investigators
Layout table for investigator information
Study Director: Javier Crespo García, MDPhD Head of Gastroenterology and Hepatology at Hospital Universitario Marqués de Valdecilla
Principal Investigator: Carmen Cobo Pelayo, MD Ministerio del Interior. Secretaría General de Instituciones Penitenciarias

Publications:
Layout table for additonal information
Responsible Party: Instituto de Investigación Marqués de Valdecilla
ClinicalTrials.gov Identifier: NCT02768961     History of Changes
Other Study ID Numbers: JCG-SOFLDP-2015-01
First Posted: May 11, 2016    Key Record Dates
Last Update Posted: May 18, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Instituto de Investigación Marqués de Valdecilla:
sofosbuvir
ledipasvir
ribavirin
prisoner
hepatitis c
prevalence
hepatitis b
Additional relevant MeSH terms:
Layout table for MeSH terms
Virus Diseases
RNA Virus Infections
Ledipasvir
Ledipasvir, sofosbuvir drug combination
Hepatitis A
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Flaviviridae Infections
Ribavirin
Sofosbuvir
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents