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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02064049




Registration number
NCT02064049
Ethics application status
Date submitted
12/02/2014
Date registered
17/02/2014

Titles & IDs
Public title
Surveillance and Treatment of Prisoners With Hepatitis C
Scientific title
A Pilot Study to Assess the Feasibility of Hepatitis C Virus (HCV) Treatment as Prevention With Interferon-free Direct Acting Antivirals (DAAs) in the Prison Setting
Secondary ID [1] 0 0
VHCRP1302
Universal Trial Number (UTN)
Trial acronym
SToP-C
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C 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 - Sofosbuvir/velpatasvir

Experimental: Hepatitis C treatment - All prisoners (in participating correctional centres) with hepatitis c, as identified during the hepatitis C surveillance phase of the study will be offered treatment for hepatitis C. The treatment course is sofosbuvir/velpatasvir 400/100mg for 12 weeks (1 tablet once daily).


Treatment: Drugs: Sofosbuvir/velpatasvir
The treatment phase will commence in year 2. This is 12 weeks of the pangenotypic sofosbuvir/velpatasvir 400/100mg, coformulated into one tablet daily.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Hepatitis C virus (HCV) incidence
Timepoint [1] 0 0
2 years
Secondary outcome [1] 0 0
Hepatitis C virus prevalence
Timepoint [1] 0 0
2 years
Secondary outcome [2] 0 0
SVR12
Timepoint [2] 0 0
24 weeks
Secondary outcome [3] 0 0
ETR
Timepoint [3] 0 0
12 weeks
Secondary outcome [4] 0 0
Rapid Virological Response (RVR)
Timepoint [4] 0 0
4 weeks
Secondary outcome [5] 0 0
Treatment adherence
Timepoint [5] 0 0
12 weeks
Secondary outcome [6] 0 0
Number of patients with adverse events
Timepoint [6] 0 0
16 weeks
Secondary outcome [7] 0 0
Treatment uptake
Timepoint [7] 0 0
2 years
Secondary outcome [8] 0 0
On-treatment change in illicit drug use
Timepoint [8] 0 0
24 weeks
Secondary outcome [9] 0 0
HCV reinfection rate
Timepoint [9] 0 0
2 years

Eligibility
Key inclusion criteria
Surveillance of HCV Incidence and Prevalence Inclusion criteria

1. 18 years of age or older
2. Voluntarily signed the (surveillance phase) informed consent form.
3. Adequate English and mental health status to provide written informed consent and comply with study procedures
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria

1) Prisoners of a security classification which makes clinic attendance for study visits logistically difficult 5.2 Treatment Intervention Inclusion criteria

1. 18 years of age or older.
2. Voluntarily signed the (treatment phase) informed consent form.
3. Detectable HCV RNA in plasma.
4. HCV genotypes 1-6
5. Anticipated incarceration duration >12 weeks following the planned commencement of therapy.
6. Compensated liver disease where the following criteria must be met:

1. INR< 1.8
2. Albumin >30 g/L
3. Bilirubin <35umol/L
7. Prisoners with Fibroscan > 12KPa or AFP >50 ng/mL must have an abdominal ultrasound or CT scan without evidence of hepatocellular carcinoma within 2 months prior to screening.
8. Negative pregnancy test at baseline (females of childbearing potential only).
9. [For prisoners released during treatment or follow-up] If engaging in sexual intercourse which may potentially result in pregnancy, all fertile males must be using effective contraception during treatment and during the 90 days after treatment end, and all fertile females must be using effective contraception during treatment and during the 30 days after treatment end
10. If co-infection with HIV is documented, the subject must meet the following criteria:

1. Antiretroviral (ARV) untreated for >8 weeks preceding screening visit with CD4 T cell count >500 cells/mm3 OR
2. On a stable ARV regimen for >8 weeks prior to screening visit, with CD4 T cell count >200 cells/mm3 and an undetectable plasma HIV RNA level.

* Suitable ARV include:

* Nucleos(t)ide reverse transcriptase inhibitors: Tenofovir disoproxil fumarate (TDF), tenofovir alafenamide (TAF), emtricitabine (FTC)Non-nucleoside reverse transcriptase inhibitors: Rilpivirine
* Protease inhibitors: Atazanavir, darunavir, lopinavir, ritonavir
* Integrase inhibitors: Dolutegravir, raltegravir, elvitegravir/cobicistat
* Contraindicated ARV include:

* Efavirenz (50% reduction in velpatasvir exposure)
* Didanosine
* Zidovudine
* Tipranavir Other ARV agents may be permissible at the time of study commencement pending further drug-drug interaction studies; please discuss with the Medical Monitor.

Exclusion criteria

1. Therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) <6 months prior to the first dose of study drug.
2. Any investigational drug <6 weeks prior to the first dose of study drug.
3. History or other evidence of clinical hepatic decompensation (i.e. ascites, encephalopathy or oesophageal variceal haemorrhage)
4. Solid organ transplant
5. Clinically significant illness (other than HCV) or any other major medical disorder that may interfere with the prisoner treatment, assessment or compliance with the protocol; prisoners currently under evaluation for a potentially clinically significant illness (other than HCV) are also excluded.
6. History of any of the following:

1. Malignancy within 5 years prior to screening, with exception of specific cancers that may have been cured by surgical resection (basal cell skin cancer, etc.). Subjects under evaluation for possible malignancy are also excluded.
2. Significant drug allergy (such as anaphylaxis or hepatotoxicity).
7. Any of the following lab parameters at screening:

1. ALT > 10 x ULN
2. AST > 10 x ULN
3. Direct bilirubin > 1.5 x ULN
4. Platelets < 50,000/uL
5. Creatinine clearance < 60 mL/min
6. Haemoglobin < 11 g/dL for females ; < 12 g/dL for males
7. Albumin < 30g/L
8. INR > 1.5 ULN unless subject has known haemophilia or is stable on an anticoagulant regimen affecting INR
8. Chronic use of systemically administered immunosuppressive agents (e.g. prednisone equivalent > 10 mg/day)
9. Known hypersensitivity to VEL, SOF or formulation excipients.
10. Use of prohibited concomitant medications as described in section 6.2
11. Pregnant or nursing female
12. Ongoing severe psychiatric disease as judged by the treating physician.
13. Frequent injecting drug use that is judged by the treating physician to compromise treatment safety.
14. Inability or unwillingness to provide informed consent or abide by the requirements of the study.
15. Any other criteria that is judged by the treating physician to potentially compromise treatment safety.

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
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
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2019
Sample size
Target
Accrual to date
Final
3692
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Goulburn Correctional Centre - Goulburn
Recruitment hospital [2] 0 0
Lithgow Correctional Centre - Lithgow
Recruitment hospital [3] 0 0
Dillwynia Correctional Centre - Windsor
Recruitment hospital [4] 0 0
Outer Metropolitan Multipurpose Correctional Centre - Windsor
Recruitment postcode(s) [1] 0 0
2580 - Goulburn
Recruitment postcode(s) [2] 0 0
2790 - Lithgow
Recruitment postcode(s) [3] 0 0
2756 - Windsor

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gregory Dore, MBBS,PhD
Address 0 0
Kirby Institute, University of New South Wales; St Vincent's Hospital Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02064049