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出境医 / 临床实验 / Treatment of HOsPitalised Inpatients for Hepatitis C (TOPIC): Therapeutic Intervention Enhancing Care Linkage in People Who Inject Drugs (TOPIC)

Treatment of HOsPitalised Inpatients for Hepatitis C (TOPIC): Therapeutic Intervention Enhancing Care Linkage in People Who Inject Drugs (TOPIC)

Study Description
Brief Summary:
This study will evaluate the proportion of patients achieving confirmed SVR12 (undetectable HCV RNA at time point 12 weeks plus post treatment commencement) in patients hospitalised for IRID (injecting related infectious diseases) and commencing inpatient DAA treatment within public hospital services.

Condition or disease Intervention/treatment Phase
Hepatitis C Liver Inflammation Liver Cirrhoses Drug: Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet Drug: Sofosbuvir 400 MG + Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet Not Applicable

Detailed Description:

This study will be conducted as a Phase IV, multicentre, sequential cohort trial.

60 participants will be enrolled from participating hospital inpatient services. They will be evaluated for eligibility by the use of rapid point-of-care (POC) confirmation of viraemia in people who inject drugs (PWID) hospitalised for IRID. The period of hospitalisation for management of IRID, particularly when prolonged, may represent an ideal opportunity to engage HCV-infected PWID and a potential important strategy for broader HCV elimination.

Eligible patients will be enrolled into one of two treatment cohorts A and B.

A) 30 patients will immediately commence treatment whilst an inpatient of G/P (glecaprevir/pibrentasvir) with continuation of therapy and follow-up in viral hepatitis services post discharge (standard duration therapy).

Following the successful completion of Cohort A, eligible patients will be enrolled into Cohort B.

B) 30 patients will immediately commence treatment whilst an inpatient of 4 weeks of SOF/G/P (sofosbuvir/glecaprevir/pibrentasvir) with continuation of therapy and follow-up in viral hepatitis services post discharge (short duration therapy).

Any patient with recurrent viraemia during follow-up will be genotyped +/- sequenced to exclude re-infection. If relapse is confirmed the patient will be offered re-treatment with standard of care (SOC) salvage therapy based on results of resistance testing.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of HOsPitalised Inpatients for Hepatitis C (TOPIC): Strategic Therapeutic Intervention to Enhance Linkage to Care in People Who Inject Drugs
Actual Study Start Date : February 12, 2021
Estimated Primary Completion Date : February 12, 2022
Estimated Study Completion Date : February 12, 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: Cohort A: 8 weeks G/P standard therapy
8 weeks treatment of a three fixed-dose combination of glecaprevir/pibrentasvir 100/40 mg tablets administered once daily with food (standard duration therapy).
Drug: Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet
8 weeks of 3 x co-formulated tablets of glecaprevir (100mg) and pibrentasvir (40mg) once daily or 4 weeks of 1 tablet sofosbuvir 400 mg and a three fixed-dose combination of glecaprevir/pibrentasvir 100/40 mg tablets administered once daily

Experimental: Cohort B: 4 weeks SOF/G/P shortened therapy
4 weeks treatment of 1 tablet sofosbuvir 400 mg and a three fixed-dose combination of glecaprevir/pibrentasvir 100/40 mg tablets administered once daily with food (shortened duration therapy).
Drug: Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet
8 weeks of 3 x co-formulated tablets of glecaprevir (100mg) and pibrentasvir (40mg) once daily or 4 weeks of 1 tablet sofosbuvir 400 mg and a three fixed-dose combination of glecaprevir/pibrentasvir 100/40 mg tablets administered once daily

Drug: Sofosbuvir 400 MG + Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet
4 weeks of 1 x sofosbuvir (400mg) tablet and 3 x co-formulated tablets of glecaprevir (100mg) and pibrentasvir (40mg) once daily

Outcome Measures
Primary Outcome Measures :
  1. SVR12 outcomes for all total patient population [ Time Frame: 12 weeks post completion of commenced treatment ]
    To evaluate the proportion of patients achieving confirmed SVR12 (undetectable HCV RNA at time point 12 weeks plus post treatment commencement) in patients hospitalised for IRID and commencing inpatient DAA treatment within public hospital services.


Eligibility Criteria
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
Criteria

Inclusion Criteria:

Participants must meet all of the following inclusion criteria to be eligible to participate in this study.

  1. Have voluntarily signed the informed consent form.
  2. 18 years of age or older.
  3. Injected drugs within the last 6 months
  4. Hospitalised with an IRID with an anticipated inpatient stay of > 1 week

    Participants must meet the following additional inclusion criteria to be treated in this study.

  5. HCV RNA positive
  6. Compensated liver disease
  7. Documented non-cirrhotic at enrolment with a qualifying liver FibroScan ≤ 9.5 kpA
  8. If co-infection with HIV is documented, the subject must meet the following criteria:

    1. ART naïve with CD4 T cell count >500 cells/mm3; OR
    2. On a stable ART regimen (containing only permissible ART) for >4 weeks prior to screening visit, with CD4 T cell count ≥200 cells/mm3 and a plasma HIV RNA level below the limit of detection.

Exclusion Criteria:

Participants who meet any of the exclusion criteria are not to be enrolled in this study.

  1. Inability or unwillingness to provide informed consent or abide by the requirements of the study
  2. Actively intoxicated.

    Participants that meet any of the additional exclusion criteria are not to be treated in this study.

  3. History of any of the following:

    b. Clinical hepatic compensation (i.e. ascites, encephalopathy or variceal haemorrhage) c. Solid organ transplant d. History of severe, life-threatening or other significant sensitivity to study drugs (glecaprevir/pibrentasvir/sofosbuvir) or any excipients of the study drugs

  4. Creatinine clearance (CLcr) < 30 mL/min at screening (Cohort B only)
  5. Pregnant or nursing female
  6. Decompensated liver disease
  7. Use of prohibited concomitant medications
  8. Chronic use of systemically administered immunosuppressive agents (e.g. prednisone equivalent > 10 mg/day for >2 weeks)
  9. Prior treatment failure with an NS5A based DAA regimen

Patients without an IRID but who fulfill all other criteria and are admitted with an expected duration of stay > 1 week may also be included at discretion of study team.

Contacts and Locations

Contacts
Layout table for location contacts
Contact: Amanda Erratt 61 2 9385 0882 aerratt@kirby.unsw.edu.au
Contact: Pip Marks 61 2 9385 0886 pmarks@kirby.unsw.edu.au

Locations
Layout table for location information
Australia, New South Wales
Prince of Wales Hospital Not yet recruiting
Randwick, New South Wales, Australia, 2031
Contact: Jeffrey Post       Jeffrey.Post@health.nsw.gov.au   
Principal Investigator: Jeffrey Post         
St Vincent's Hospital Sydney Recruiting
Sydney, New South Wales, Australia, 2010
Contact: Gail Matthews       gmatthews@kirby.unsw.edu.au   
Principal Investigator: Gail Matthews, MBChB PhD         
Blacktown Mt Druitt Hospital Not yet recruiting
Sydney, New South Wales, Australia, 2148
Contact: Golo Ahlenstiel, MD       golo.ahlenstiel@health.nsw.gov.au   
Principal Investigator: Golo Ahlenstiel         
Westmead Hospital Not yet recruiting
Westmead, New South Wales, Australia, 2145
Contact: Mark Douglas       mark.douglas@sydney.edu.au   
Principal Investigator: Mark Douglas         
Australia, South Australia
Royal Adelaide Hospital Not yet recruiting
Adelaide, South Australia, Australia, 5000
Contact: Emily Rowe       emily.rowe@sa.gov.au   
Principal Investigator: Emily Rowe         
Australia, Victoria
The Alfred Hospital Not yet recruiting
Melbourne, Victoria, Australia, 3004
Contact: Joseph Doyle       joseph.doyle@burnet.edu.au   
Principal Investigator: Joseph Doyle         
St Vincent's Hospital Not yet recruiting
Melbourne, Victoria, Australia, 3065
Contact: Alexander Thompson       Alexander.THOMPSON@svha.org.au   
Principal Investigator: Alexander Thompson         
Sponsors and Collaborators
Kirby Institute
Tracking Information
First Submitted Date  ICMJE May 31, 2019
First Posted Date  ICMJE June 10, 2019
Last Update Posted Date February 21, 2021
Actual Study Start Date  ICMJE February 12, 2021
Estimated Primary Completion Date February 12, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2019)
SVR12 outcomes for all total patient population [ Time Frame: 12 weeks post completion of commenced treatment ]
To evaluate the proportion of patients achieving confirmed SVR12 (undetectable HCV RNA at time point 12 weeks plus post treatment commencement) in patients hospitalised for IRID and commencing inpatient DAA treatment within public hospital services.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of HOsPitalised Inpatients for Hepatitis C (TOPIC): Therapeutic Intervention Enhancing Care Linkage in People Who Inject Drugs
Official Title  ICMJE Treatment of HOsPitalised Inpatients for Hepatitis C (TOPIC): Strategic Therapeutic Intervention to Enhance Linkage to Care in People Who Inject Drugs
Brief Summary This study will evaluate the proportion of patients achieving confirmed SVR12 (undetectable HCV RNA at time point 12 weeks plus post treatment commencement) in patients hospitalised for IRID (injecting related infectious diseases) and commencing inpatient DAA treatment within public hospital services.
Detailed Description

This study will be conducted as a Phase IV, multicentre, sequential cohort trial.

60 participants will be enrolled from participating hospital inpatient services. They will be evaluated for eligibility by the use of rapid point-of-care (POC) confirmation of viraemia in people who inject drugs (PWID) hospitalised for IRID. The period of hospitalisation for management of IRID, particularly when prolonged, may represent an ideal opportunity to engage HCV-infected PWID and a potential important strategy for broader HCV elimination.

Eligible patients will be enrolled into one of two treatment cohorts A and B.

A) 30 patients will immediately commence treatment whilst an inpatient of G/P (glecaprevir/pibrentasvir) with continuation of therapy and follow-up in viral hepatitis services post discharge (standard duration therapy).

Following the successful completion of Cohort A, eligible patients will be enrolled into Cohort B.

B) 30 patients will immediately commence treatment whilst an inpatient of 4 weeks of SOF/G/P (sofosbuvir/glecaprevir/pibrentasvir) with continuation of therapy and follow-up in viral hepatitis services post discharge (short duration therapy).

Any patient with recurrent viraemia during follow-up will be genotyped +/- sequenced to exclude re-infection. If relapse is confirmed the patient will be offered re-treatment with standard of care (SOC) salvage therapy based on results of resistance testing.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hepatitis C
  • Liver Inflammation
  • Liver Cirrhoses
Intervention  ICMJE
  • Drug: Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet
    8 weeks of 3 x co-formulated tablets of glecaprevir (100mg) and pibrentasvir (40mg) once daily or 4 weeks of 1 tablet sofosbuvir 400 mg and a three fixed-dose combination of glecaprevir/pibrentasvir 100/40 mg tablets administered once daily
  • Drug: Sofosbuvir 400 MG + Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet
    4 weeks of 1 x sofosbuvir (400mg) tablet and 3 x co-formulated tablets of glecaprevir (100mg) and pibrentasvir (40mg) once daily
Study Arms  ICMJE
  • Experimental: Cohort A: 8 weeks G/P standard therapy
    8 weeks treatment of a three fixed-dose combination of glecaprevir/pibrentasvir 100/40 mg tablets administered once daily with food (standard duration therapy).
    Intervention: Drug: Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet
  • Experimental: Cohort B: 4 weeks SOF/G/P shortened therapy
    4 weeks treatment of 1 tablet sofosbuvir 400 mg and a three fixed-dose combination of glecaprevir/pibrentasvir 100/40 mg tablets administered once daily with food (shortened duration therapy).
    Interventions:
    • Drug: Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet
    • Drug: Sofosbuvir 400 MG + Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 6, 2019)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 12, 2022
Estimated Primary Completion Date February 12, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Participants must meet all of the following inclusion criteria to be eligible to participate in this study.

  1. Have voluntarily signed the informed consent form.
  2. 18 years of age or older.
  3. Injected drugs within the last 6 months
  4. Hospitalised with an IRID with an anticipated inpatient stay of > 1 week

    Participants must meet the following additional inclusion criteria to be treated in this study.

  5. HCV RNA positive
  6. Compensated liver disease
  7. Documented non-cirrhotic at enrolment with a qualifying liver FibroScan ≤ 9.5 kpA
  8. If co-infection with HIV is documented, the subject must meet the following criteria:

    1. ART naïve with CD4 T cell count >500 cells/mm3; OR
    2. On a stable ART regimen (containing only permissible ART) for >4 weeks prior to screening visit, with CD4 T cell count ≥200 cells/mm3 and a plasma HIV RNA level below the limit of detection.

Exclusion Criteria:

Participants who meet any of the exclusion criteria are not to be enrolled in this study.

  1. Inability or unwillingness to provide informed consent or abide by the requirements of the study
  2. Actively intoxicated.

    Participants that meet any of the additional exclusion criteria are not to be treated in this study.

  3. History of any of the following:

    b. Clinical hepatic compensation (i.e. ascites, encephalopathy or variceal haemorrhage) c. Solid organ transplant d. History of severe, life-threatening or other significant sensitivity to study drugs (glecaprevir/pibrentasvir/sofosbuvir) or any excipients of the study drugs

  4. Creatinine clearance (CLcr) < 30 mL/min at screening (Cohort B only)
  5. Pregnant or nursing female
  6. Decompensated liver disease
  7. Use of prohibited concomitant medications
  8. Chronic use of systemically administered immunosuppressive agents (e.g. prednisone equivalent > 10 mg/day for >2 weeks)
  9. Prior treatment failure with an NS5A based DAA regimen

Patients without an IRID but who fulfill all other criteria and are admitted with an expected duration of stay > 1 week may also be included at discretion of study team.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Amanda Erratt 61 2 9385 0882 aerratt@kirby.unsw.edu.au
Contact: Pip Marks 61 2 9385 0886 pmarks@kirby.unsw.edu.au
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03981211
Other Study ID Numbers  ICMJE VHCRP1902
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kirby Institute
Study Sponsor  ICMJE Kirby Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Kirby Institute
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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