NCT04063839

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

June 27, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 21, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

August 21, 2019

Status Verified

August 1, 2019

Enrollment Period

4.8 years

First QC Date

June 27, 2019

Last Update Submit

August 20, 2019

Conditions

Hepatitis CSubstance Use Disorders

Outcome Measures

Primary Outcomes (2)

  • Sustained virological response

    HCV RNA undetectable 12 weeks post treatment

    12 weeks

  • Reinfection

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

    2 years

Interventions

Elbasvir / Grazoprevir Oral TabletDRUG

HCV treatment according to Norwegian guidelines

Also known as: sofosbuvir, ledipasvir

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AkershusUH

Lørenskog, Select A State Or Province, 0278, Norway

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma collected at baseline and stored frozen -70 C

MeSH Terms

Conditions

Hepatitis CSubstance-Related Disorders

Interventions

elbasvir-grazoprevir drug combinationSofosbuvirledipasvir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Uridine MonophosphateUracil NucleotidesPyrimidine NucleotidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleotidesNucleic Acids, Nucleotides, and NucleosidesRibonucleotides

Study Officials

  • Olav Dalgard, MD PhD

    University Hospital, Akershus

    STUDY CHAIR

Central Study Contacts

Olav Dalgard, MD PhD

CONTACT

92616800odalgard@medisin.uio.no

Kjersti Ulstein, MD

CONTACT

41226162kjersti.ulstein@vel.oslo.kommune

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 27, 2019

First Posted

August 21, 2019

Study Start

January 1, 2015

Primary Completion

October 31, 2019

Study Completion

December 1, 2022

Last Updated

August 21, 2019

Record last verified: 2019-08

Locations

NO(1)