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Opportunstic Hepatitis C Virus Treatment (Opportuni-C)

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ClinicalTrials.gov Identifier: NCT04220645
Recruitment Status : Recruiting
First Posted : January 7, 2020
Last Update Posted : January 7, 2020
Sponsor:
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.

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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

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

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 ClinicalTrials.gov identifier (NCT number): NCT04220645


Contacts
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Contact: Olav Dalgard, MD PhD 92616800 ext 47 odalgard@medisin.uio.no
Contact: Håvard Midgard, MD PhD 90830071 ext 47 havard.midgard@medisin.uio.no

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: Håvard Midgard, MD PhD    90830071 ext 0047    havard.midgard@medisin.uio.no   
Sponsors and Collaborators
University Hospital, Akershus
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Olav Dalgard, Professor, University Hospital, Akershus
ClinicalTrials.gov 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

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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:
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Hepatitis A
Hepatitis C
Hepatitis
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