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Prindsen: HCV Treatment in a Low-threshold Clinic

Sponsor
University Hospital, Akershus (Other)
Overall Status
Recruiting
CT.gov ID
NCT04063839
Collaborator
(none)
300
Enrollment
1
Location
95
Anticipated Duration (Months)
3.2
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • 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

Study Design

Study Type:
Observational
Anticipated 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 :
Jan 1, 2015
Anticipated Primary Completion Date :
Oct 31, 2019
Anticipated Study Completion Date :
Dec 1, 2022

Outcome Measures

Primary Outcome Measures

  1. Sustained virological response [12 weeks]

    HCV RNA undetectable 12 weeks post treatment

  2. Reinfection [2 years]

    HCV RNA detectable after SVR 12 in a patient who injected drugs post SVR 12

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • HCV RNA positive Attending the low-threshold HCV clinic in Oslo
Exclusion Criteria:

Contacts and Locations

Locations

Site City State Country Postal Code
1 AkershusUH Lørenskog Select A State Or Province Norway 0278

Sponsors and Collaborators

  • University Hospital, Akershus

Investigators

  • Study Chair: Olav Dalgard, MD PhD, University Hospital, Akershus

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Olav Dalgard, Professor, University Hospital, Akershus
ClinicalTrials.gov Identifier:
NCT04063839
Other Study ID Numbers:
  • 17_120
First Posted:
Aug 21, 2019
Last Update Posted:
Aug 21, 2019
Last Verified:
Aug 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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:
Hepatitis C
Hepatitis
Substance-Related Disorders
Sofosbuvir
Grazoprevir
Ledipasvir
Elbasvir-grazoprevir drug combination

Study Results

No Results Posted as of Aug 21, 2019