COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu
Trial record 1 of 1 for:    opportuni-c
Previous Study | Return to List | Next Study

Opportunstic Hepatitis C Virus Treatment (Opportuni-C)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04220645
Recruitment Status : Recruiting
First Posted : January 7, 2020
Last Update Posted : January 7, 2020
Information provided by (Responsible Party):
Olav Dalgard, University Hospital, Akershus

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hepatitis C Substance Use Disorders Other: Opportunstic treatment Other: Standard of care Not Applicable

Detailed Description:

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Pragmatic clinical trial. Cluster randomised with stepped wedge design
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Opportunistic Treatment of Hepatitis C Virus Infection (OPPORTUNI-C): A Pragmatic Clinical Trial of Immediate Versus Outpatient Treatment Initiation Among Hospitalized Patients
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Standard of care
Hospitalised patients with hep C are referred to the outpatient clinic at the medical department following discharge.
Other: Standard of care
Referral at discharge

Experimental: Opportunistic treatment
Hospitalised patients with hep C are opportunistically and immediately treated when hospitalized for acute care in psychiatric, addiction treatment or somatic wards
Other: Opportunstic treatment
opportunistically treating HCV infection immediately when hep C patients are hospitalized for acute care in psychiatric, addiction treatment or somatic wards

Primary Outcome Measures :
  1. Treatment completion [ Time Frame: 12 weeks ]
    Proportion in each arm who have been dispensed the last 28 days package of HCV treatment

Secondary Outcome Measures :
  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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

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 identifier (NCT number): NCT04220645

Layout table for location contacts
Contact: Olav Dalgard, MD PhD 92616800 ext 47
Contact: Håvard Midgard, MD PhD 90830071 ext 47

Layout table for location information
AkershusUH Recruiting
Lørenskog, Select A State Or Province, Norway, 0278
Contact: Olav Dalgard, MD PhD    92616800   
Contact: Håvard Midgard, MD PhD    90830071 ext 0047   
Sponsors and Collaborators
University Hospital, Akershus
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Olav Dalgard, Professor, University Hospital, Akershus Identifier: NCT04220645    
Other Study ID Numbers: 2019/128
First Posted: January 7, 2020    Key Record Dates
Last Update Posted: January 7, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis A
Hepatitis C
Substance-Related Disorders
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Chemically-Induced Disorders
Mental Disorders