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Trial record 67 of 82 for:    GRAZOPREVIR ANHYDROUS AND ELBASVIR

HCV Treatment in a Low-threshold Clinic (Prindsen)

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ClinicalTrials.gov Identifier: NCT04063839
Recruitment Status : Recruiting
First Posted : August 21, 2019
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
Olav Dalgard, University Hospital, Akershus

Brief Summary:
This is a cohort of people who inject drugs with chronic HCV infection. Patients are seen at a low-threshold clinic. All patients are offered treatment for HCV and subsequently followed for to years

Condition or disease Intervention/treatment
Hepatitis C Substance Use Disorders Drug: Elbasvir / Grazoprevir Oral Tablet

Detailed Description:

This is a cohort of people who inject drugs with chronic HCV infection. Patients are seen at a low-threshold clinic. All patients are offered treatment for HCV and subsequently followed for to years

Inclusion Consenting patients older than 18 years attending the low threshold HCV clinic in Oslo

The primary aims are to assess the efficacy (SVR rate) of DAA treatment among PWID treated in a low-threshold primary care setting (Work Package 1) and to estimate the incidence HCV reinfection f

The secondary aims are to:

  • Evaluate adherence to DAA treatment (Work Package 1)
  • Identify factors associated with SVR and adherence (Work Package 1)
  • Characterize reinfection using next generation sequencing (Work Package 2)
  • Identify factors associated with reinfection (Work Package 2)
  • Evaluate changes in recent injecting risk behaviours longitudinally (Work Package 2)
  • Identify factors associated with changes in risk behaviours (Work Package 2)

The hypothesis is that high SVR rates and good treatment adherence will be achieved in PWID treated for HCV infection in a low-threshold primary health care setting. Further,it is anticipated that the incidence of reinfection will be 5-10/100 PY and associated with younger age, low education level and ongoing injecting risk behaviours.

The study will include 300 patients and are close to achieving that aim the summer of 2019


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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Management of Hepatitis C Virus Infection Among People Who Inject Drugs in a Low-threshold Setting: Efficacy of Direct-acting Antiviral Treatment and the Risk of Reinfection
Actual Study Start Date : January 2015
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: Elbasvir / Grazoprevir Oral Tablet
    HCV treatment according to Norwegian guidelines
    Other Names:
    • sofosbuvir
    • ledipasvir


Primary Outcome Measures :
  1. Sustained virological response [ Time Frame: 12 weeks ]
    HCV RNA undetectable 12 weeks post treatment

  2. Reinfection [ Time Frame: 2 years ]
    HCV RNA detectable after SVR 12 in a patient who injected drugs post SVR 12


Biospecimen Retention:   Samples Without DNA
Plasma collected at baseline and stored frozen -70 C


Information from the National Library of Medicine

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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
Ever injected drugs (100%) OAT (70%) Recent injecting drug use (70%)
Criteria

Inclusion Criteria:

  • HCV RNA positive Attending the low-threshold HCV clinic in Oslo

Exclusion Criteria:

-


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): NCT04063839


Contacts
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Contact: Olav Dalgard, MD PhD 92616800 ext 47 odalgard@medisin.uio.no
Contact: Kjersti Ulstein, MD 41226162 ext 47 kjersti.ulstein@vel.oslo.kommune

Locations
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Norway
AkershusUH Recruiting
Lørenskog, Select A State Or Province, Norway, 0278
Contact: Olav Dalgard, MD PhD    92616800    odalgard@medisin.uio.no   
Contact: Kjersti Ulstein, MD PhD    41226162 ext 0047    kjersti.ulstein@vel.oslo.kommune.no   
Sponsors and Collaborators
University Hospital, Akershus
Investigators
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Study Chair: Olav Dalgard, MD PhD University Hospital, Akershus

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Responsible Party: Olav Dalgard, Professor, University Hospital, Akershus
ClinicalTrials.gov Identifier: NCT04063839     History of Changes
Other Study ID Numbers: 17_120
First Posted: August 21, 2019    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: depends on patient privacy decission

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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MK-5172
Hepatitis C
Hepatitis
Substance-Related Disorders
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
RNA Virus Infections
Flaviviridae Infections
Chemically-Induced Disorders
Mental Disorders
Antiviral Agents
Anti-Infective Agents