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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03981211




Registration number
NCT03981211
Ethics application status
Date submitted
31/05/2019
Date registered
10/06/2019
Date last updated
6/03/2024

Titles & IDs
Public title
Treatment of HOsPitalised Inpatients for Hepatitis C (TOPIC): Therapeutic Intervention Enhancing Care Linkage in People Who Inject Drugs
Scientific title
Treatment of HOsPitalised Inpatients for Hepatitis C (TOPIC): Strategic Therapeutic Intervention to Enhance Linkage to Care in People Who Inject Drugs
Secondary ID [1] 0 0
VHCRP1902
Universal Trial Number (UTN)
Trial acronym
TOPIC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C 0 0
Liver Inflammation 0 0
Liver Cirrhoses 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet
Treatment: Drugs - Sofosbuvir 400 MG + Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet

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).

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).


Treatment: Drugs: 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

Treatment: Drugs: 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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
SVR12 outcomes for all total patient population
Timepoint [1] 0 0
12 weeks post completion of commenced treatment

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/02/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
12/02/2025
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [2] 0 0
St Vincent's Hospital Sydney - Sydney
Recruitment hospital [3] 0 0
Blacktown Mt Druitt Hospital - Sydney
Recruitment hospital [4] 0 0
Westmead Hospital - Westmead
Recruitment hospital [5] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [6] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [7] 0 0
St Vincent's Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
2010 - Sydney
Recruitment postcode(s) [3] 0 0
2148 - Sydney
Recruitment postcode(s) [4] 0 0
2145 - Westmead
Recruitment postcode(s) [5] 0 0
5000 - Adelaide
Recruitment postcode(s) [6] 0 0
3004 - Melbourne
Recruitment postcode(s) [7] 0 0
3065 - Melbourne

Funding & Sponsors
Primary sponsor type
Government body
Name
Kirby Institute
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT03981211
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Amanda Erratt
Address 0 0
Country 0 0
Phone 0 0
61 2 9385 0882
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03981211