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

NCT02768961 | Completed Phase 4

• 1 other identifier: JCG-SOFLDP-2015-01
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of this study are:

1. 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. 2.To perform an adequate characterization of patients and the characteristics of HCV infection in this population.
3. 3.To evaluate the effectiveness and security in the prison population of an interferon-free antiviral regimen.
4. 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.

Conditions

Hepatitis C

Keywords

sofosbuvir; ledipasvir; ribavirin; prisoner; hepatitis c; prevalence; hepatitis b

Outcome Measures

Primary Outcomes (2)

• Prevalence of chronic hepatitis C

  Percentage of viremic hepatitis C patients with respect to the whole inmate population

  12 months after the beginning of the study.

• Percentage of Participants with Sustained Virological Response

  Percentage of Participants with Sustained Virological Response (undetectable viral load) at this point

  12 weeks after the end of treatment

Secondary Outcomes (9)

• Adverse events

  4 weeks after the start of treatment

• Adverse events

  8 weeks after the start of treatment

• Adverse events

  12 weeks after the start of treatment

• Adverse events

  24 weeks after the start of treatment

• Percentage of Participants with Sustained Virological Response

  4 weeks after the end of treatment

Study Arms (1)

Active treatment

EXPERIMENTAL

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; Drug: ledipasvir

Interventions

sofosbuvir DRUG

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

Also known as: Harvoni

Active treatment

ledipasvir DRUG

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

Also known as: Harvoni

Active treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto de Investigación Marqués de Valdecilla: lead

Study Sites (1)

Penitentiary "El Dueso". Cantabria. Spain

Santoña, Cantabria, 39740, Spain

Location

Related Publications (2)

• European Association for Study of Liver. 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. No abstract available.

  PMID: 25911336 BACKGROUND

• Rice JP, Burnett D, Tsotsis H, Lindstrom MJ, Cornett DD, Voermans P, Sawyer J, Striker R, Lucey MR. Comparison of hepatitis C virus treatment between incarcerated and community patients. Hepatology. 2012 Oct;56(4):1252-60. doi: 10.1002/hep.25770.

  PMID: 22505121 BACKGROUND

MeSH Terms

Conditions

Hepatitis C; Hepatitis B

Interventions

Sofosbuvir; ledipasvir, sofosbuvir drug combination; ledipasvir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Hepadnaviridae Infections; DNA Virus Infections

Intervention Hierarchy (Ancestors)

Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• Javier Crespo García, MDPhD

  Head of Gastroenterology and Hepatology at Hospital Universitario Marqués de Valdecilla

  STUDY DIRECTOR

• Carmen Cobo Pelayo, MD

  Ministerio del Interior. Secretaría General de Instituciones Penitenciarias

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2016
• First Posted: May 11, 2016
• Study Start: May 10, 2016
• Primary Completion: May 10, 2017
• Study Completion: May 10, 2017
• Last Updated: May 18, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)