Condition or disease | Intervention/treatment | Phase |
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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 |
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 : | 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 |
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).
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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
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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
|
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Participants must meet all of the following inclusion criteria to be eligible to participate in this study.
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.
If co-infection with HIV is documented, the subject must meet the following criteria:
Exclusion Criteria:
Participants who meet any of the exclusion criteria are not to be enrolled in this study.
Actively intoxicated.
Participants that meet any of the additional exclusion criteria are not to be treated in this study.
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
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.
Contact: Amanda Erratt | 61 2 9385 0882 | aerratt@kirby.unsw.edu.au | |
Contact: Pip Marks | 61 2 9385 0886 | pmarks@kirby.unsw.edu.au |
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 |
Tracking Information | |||||||||
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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 |
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.
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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. |
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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 |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
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.
Exclusion Criteria: Participants who meet any of the exclusion criteria are not to be enrolled in this study.
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. |
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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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 |
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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 |