Skip to main content
OpenTrials
Completed

NCT Number: NCT04220645

Opportunstic Hepatitis C Virus Treatment

The project will assess the effect of opportunistically treating hepatitis C virus (HCV) infection immediately when HCV-infected people who inject drugs are hospitalized for acute care in psychiatric, interdisciplinary specialized drug treatment or somatic wards. We will compare this approach with the current standard of care (SOC), which is referral to the outpatient clinic at the medical department following discharge.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AkershusUH

Lørenskog, Select A State Or Province, 0278, Norway

About this study

The overall objective is to show that opportunistic and immediate administration of HCV treatment is more efficient compared to referral-based SOC. The specific objectives are: 1) to compare the intervention and SOC groups with regards to treatment completion, treatment uptake and virologic response ; 2) to assess the rate of reinfection after successful HCV treatment; and 3) to assess the frequency of resistant associated substitutions before and after virologic treatment failure.

We will use a stepped wedge design and include patients in 7 clusters

Following randomization of the cluster to the immediate treatment, physicians at the participating wards will be notified in writing that for the next time period patients diagnosed with HCV infection should be treated immediately. In addition, lectures presenting the opportunistic approach will be given and the Department of Microbiology will add a brief text to the result of HCV RNA testing reminding about the opportunistic approach. In the medical and the psychiatric departments, consultants from the departments of infectious diseases or gastroenterology will prescribe immediate treatment. In the departments that provide addiction treatment, local physicians will prescribe treatment. Treatment will be prescribed in accordance with current Norwegian treatment recommendations. The intensity of care after discharge will be individualized at the discretion of the treating physician.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Above 18 years of age
  • HCV RNA positive
  • Inpatient at participating ward
  • Signed informed consent must be obtained and documented according to national and local regulations

Exclusion criteria

  • Pregnancy or breastfeeding.
  • In involuntarily health care.
  • Ongoing treatment of hepatitis C.
  • Current participation in another trial that might affect the current study.
  • Any reason why, in the opinion of the investigator, the patient should not participate (e.g. not able to comply with study procedures).

Treatment and study plan

Opportunstic treatment

Other

opportunistically treating HCV infection immediately when hep C patients are hospitalized for acute care in psychiatric, addiction treatment or somatic wards

Standard of care

Other

Referral at discharge

Primary outcomes

  1. Treatment completion

    Time frame: 12 weeks

    Proportion in each arm who have been dispensed the last 28 days package of HCV treatment

Secondary outcomes

  1. Sustained virological response

    Time frame: 24 weeks

    HCV RNA undetetctable 12 weeks after end of treatment

  2. Reinfection

    Time frame: Two years

    A HCV RNA strain not present at baseline is detected during or after treatment

  3. End of treatment response

    Time frame: 12 weeks

    Proportion in each arm who have undetectable HCV RNA at the end of treatment

Sponsors and collaborators

Lead sponsor

University Hospital, Akershus

Other

Registry information

Official study title

Opportunistic Treatment of Hepatitis C Virus Infection (OPPORTUNI-C): A Pragmatic Clinical Trial of Immediate Versus Outpatient Treatment Initiation Among Hospitalized Patients

Acronym: Opportuni-C

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Jan 7, 2020
Registry last updated
Dec 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.