Hepatitis C VirusPhase 4NCT02460133
Understanding HCV Reinfection Rates in an Incarcerated Population After Cure With Interferon Free HCV Treatment
A Phase 4 study testing Paritaprevir, Ritonavir and Dasabuvir in people with Hepatitis C Virus, run by Nova Scotia Health Authority.
Trial summary
This pilot study is crucial to determining whether treating individuals who are at high risk for transmission or re-infection will impact HCV reinfection rates. It will establish the feasibility of DAA treatment in corrections facilities, as well as delineate the underlying immune basis of HCV cure and reinfection. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Hepatitis C Virus
- What is being tested?
- Paritaprevir, Ritonavir and Dasabuvir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 10 Jul 2015to Oct 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- An offender at the PEI Provincial Correction Centre during the enrollment time
- Male, 18 -70 years of age, inclusive, at time of screening
- Chronic HCV genotype 1 infection
- HCV infection, as demonstrated by positive HCV immunosorbant assay and detectable HCV viral load
- No evidence of decompensated liver disease (refractory ascites, variceal bleed within 1 year, active hepatic encephalopathy or Child-Pugh score greater than 6)
- HIV negative
Show all 12Show fewer
- Males must be abstinent from sexual intercourse, surgically sterile or agree to practice two effective forms of birth control from those listed below, throughout the course of the study, starting with Study Day 1 and for 7 months after the last dose of study drug (or per local RBV label):
- Partner(s) using an IUD (intrauterine device),
- Partner(s) using oral, injected, or implanted methods of hormonal contraceptives,
- Subject and/or partner(s) using condoms, contraceptive sponge, or diaphragm with spermicidal jellies or creams.
- Subjects must be able to understand and adhere to the study visit schedule and all other protocol requirements
- Must voluntarily sign and date an informed consent form, approved by a Research Ethics Board prior to the initiation of any screening or study specific procedures
Who cannot join
- History of severe, life-threatening or other significant sensitivity to any drug
- Positive test result at screening for Hepatitis B surface antigen
- Prior therapy with direct acting antivirals for the treatment of HCV
- Evidence of decompensated liver disease (current or past refractory ascites, variceal bleed within 1 year, active hepatic encephalopathy)
- HIV positive screening test
- Unwilling to follow up for 48 weeks after treatment completion
Show all 35Show fewer
- Use of any herbal supplements (including milk thistle) within 2 weeks or 10 half-lives of the respective supplement, whichever is longer, prior to the first dose of study drug
- HCV genotype performed during screening indicating unable to genotype or co-infection with any other HCV genotype
- Use of any medications contraindicated for use with the study regimen
- Clinically significant abnormalities, other than HCV-infection, based upon the results of a medical history, physical examination, vital signs, and laboratory profile that make the subject an unsuitable candidate for this study in the opinion of the investigator
- Serum Alpha-Fetoprotein (AFP) > 200 ng/mL at screening
- Any cause of liver disease other than chronic HCV-infection, including but not limited to the following:
- Hemochromatosis
- Alpha-1 antitrypsin deficiency
- Wilson's disease
- Autoimmune hepatitis
- Alcoholic liver disease
- Nonalcoholic steatohepatitis
- Drug-related liver disease
- Screening laboratory analyses showing any of the following abnormal laboratory results:
- ALT > 5 × upper limit of normal (ULN)
- Aspartate aminotransferase (AST) > 5 × ULN
- Calculated creatinine clearance (using Cockcroft-Gault method) < 60 mL/min
- Albumin 25 g/L
- Prothrombin time/International normalized ratio (INR) > 2.3.
- Hemoglobin < LLN
- Platelets < 60,000 cells per mm3
- Absolute neutrophil count (ANC) < 1500 cells/μL
- Total bilirubin ≥ 51 umol/L
- History of solid organ transplantation.
- Receipt of any investigational product within a time period equal to 10 half-lives of the product, if known, or a minimum of 6 weeks prior to study drug administration.
- Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive paritaprevir, dasabuvir, ombitasvir, ritonavir and/or RBV.
- Current enrollment in another clinical study, prior enrollment in this study, or previous exposure to paritaprevir, ombitasvir, or dasabuvir. Concurrent participation in a non-interventional, epidemiologic or registry trials may be permitted with approval of the principal investigator.
- The use of colony stimulating factors, such as granulocyte colony stimulating factor (GCSF) or erythropoietin within 2 months of the screening period.
- Uncontrolled clinically significant cardiac, respiratory (except mild asthma), hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness, which is unrelated to the hepatic disease.
About this study
Official title: Understanding HCV Reinfection Rates in an Incarcerated Population After Cure With Interferon Free HCV Treatment: A Pilot Project
This pilot study is crucial to determining whether treating individuals who are at high risk for transmission or re-infection will impact HCV reinfection rates. It will establish the feasibility of DAA treatment in corrections facilities, as well as delineate the underlying immune basis of HCV cure and reinfection.
Read the detailed description
Hepatitis C virus (HCV) is a blood-borne virus that causes both acute and chronic liver disease. Chronic HCV infection is associated with progressive liver disease and significant morbidity and mortality and represents a significant public health burden with approximately 150 million people infected worldwide. Until very recently, HCV treatment was extremely difficult for both clinicians and patients. Treatment strategies had debilitating side effects including dangerously low blood levels and clinical depression that often resulted in incomplete therapy and relatively infrequent cure (only 60-70% of individuals). In addition, the extended duration of therapy (up to one year) often precluded treatment for marginalized individuals with unstable life circumstances or intermittent incarceration.
Within the last 4 years, new direct acting antivirals (DAA) have been licensed for the treatment of HCV infection. These newly approved regimens are short (12 weeks), extremely safe, well tolerated and result in cure rates in excess of 90%.
HCV cure is defined as undetectable serum HCV viral load 12 weeks after finishing therapy. This is also termed 12 week sustained virologic response or SVR12.
In Canada, over 240,000 individuals have HCV, and the majority of new HCV infections occur through intravenous drug use. Many of these individuals encounter the federal and/or provincial corrections system at some point in their lifetime, and it is estimated that up to 80% of injection drug users (IVDU) practice needle sharing. Incarcerated individuals are a vulnerable, high risk population who are generally excluded from clinical studies and access to novel classes of antiviral therapies.
If all individuals were diagnosed, treated and cured, incident and chronic HCV infection within the incarcerated population would likely be greatly reduced (a type of harm reduction or treat to prevent strategy). Additionally, there may be an immunologic rationale for reduced rates of reinfection after viral cure with these therapies, and immune investigations in this study address this issue. Essentially, this study asks whether treatment of the majority of HCV positive individuals in a discrete population is harm reduction in and of itself. That is, individuals may have decreased susceptibility to HCV infection because of increased immunity and the population may see decreased reinfection rates because of reduced viral reservoir in the local community.
This novel pilot study is crucial to determine whether treating individuals who are at high risk for transmission or re-infection will impact HCV reinfection rates. This study will establish the feasibility of DAA treatment in corrections facilities, as well as delineate the underlying immune basis of HCV cure and reinfection.
- Conditions
- Hepatitis C Virus
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParitaprevirDrug
RitonavirDrug
DasabuvirDrug
OmbitasvirDrug
RibavirinDrug
In genotype 1b individuals without cirrhosis, treatment will NOT include ribavirin.
| Study group | Role | What they receive |
|---|---|---|
| HCV Genotype 1, with and without cirrhosis | Other | Not described Receives: Drug: Paritaprevir; Drug: Ritonavir; Drug: Dasabuvir; Drug: Ombitasvir; Drug: Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Re-infection rate in individuals treated with DAA therapy
This will require HCV quasispecies determination at baseline and in potentially re-infected individuals. Re-infection will require demonstration of HCV RNA above level of detection after SVR12 with a phyogenetically distinct HCV species.
Measured: 1 year following treatment.
Secondary outcomes (5)
Percentage of subjects with sustained virologic response at 12 weeks post treatment
Measured: 12 Weeks post treatment
Change in fibrosis measured by transient elastography
Measured: From day 0 to the end of follow-up
Global and HCV-specific T cell function before and after treatment with DAA therapy.
Measured: From day 0 to end of follow-up
Global and HCV-specific B cell function before and after treatment with DAA therapy.
Measured: From day 0 to end of follow-up
Global and HCV-specific NK cell function before and after treatment with DAA therapy.
Measured: From day 0 to end of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2015 (estimated)
- Study start10 Jul 2015
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C VirusStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Collaborators
- Provincial Correction Centre (PEI)
- Responsible party
- Sponsor
- Investigators
- Lisa Barrett, MD PhD FRCPC, Principal investigator, Department of Medicine, Division of Infectious Diseases, Nova Scotia Health Authority, Dalhousie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02460133
- Sponsor's protocol ID
- SAIL-001
- Status last verified
- Aug 2024
- First submitted
- 22 May 2015
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding HCV Reinfection Rates in an Incarcerated Population After Cure With Interferon Free HCV Treatment: A Pilot Project
- ClinicalTrials.gov ID
- NCT02460133
- Acronym / sponsor ID
- SAIL-001
- Conditions
- Hepatitis C Virus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Collaborators
- Provincial Correction Centre (PEI)
- Study start
- 10 Jul 2015 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 2 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot study is crucial to determining whether treating individuals who are at high risk for transmission or re-infection will impact HCV reinfection rates. It will establish the feasibility of DAA treatment in corrections facilities, as well as delineate the underlying immune basis of HCV cure and reinfection.
Detailed description
Hepatitis C virus (HCV) is a blood-borne virus that causes both acute and chronic liver disease. Chronic HCV infection is associated with progressive liver disease and significant morbidity and mortality and represents a significant public health burden with approximately 150 million people infected worldwide. Until very recently, HCV treatment was extremely difficult for both clinicians and patients. Treatment strategies had debilitating side effects including dangerously low blood levels and clinical depression that often resulted in incomplete therapy and relatively infrequent cure (only 60-70% of individuals). In addition, the extended duration of therapy (up to one year) often precluded treatment for marginalized individuals with unstable life circumstances or intermittent incarceration.
Within the last 4 years, new direct acting antivirals (DAA) have been licensed for the treatment of HCV infection. These newly approved regimens are short (12 weeks), extremely safe, well tolerated and result in cure rates in excess of 90%.
HCV cure is defined as undetectable serum HCV viral load 12 weeks after finishing therapy. This is also termed 12 week sustained virologic response or SVR12.
In Canada, over 240,000 individuals have HCV, and the majority of new HCV infections occur through intravenous drug use. Many of these individuals encounter the federal and/or provincial corrections system at some point in their lifetime, and it is estimated that up to 80% of injection drug users (IVDU) practice needle sharing. Incarcerated individuals are a vulnerable, high risk population who are generally excluded from clinical studies and access to novel classes of antiviral therapies.
If all individuals were diagnosed, treated and cured, incident and chronic HCV infection within the incarcerated population would likely be greatly reduced (a type of harm reduction or treat to prevent strategy). Additionally, there may be an immunologic rationale for reduced rates of reinfection after viral cure with these therapies, and immune investigations in this study address this issue. Essentially, this study asks whether treatment of the majority of HCV positive individuals in a discrete population is harm reduction in and of itself. That is, individuals may have decreased susceptibility to HCV infection because of increased immunity and the population may see decreased reinfection rates because of reduced viral reservoir in the local community.
This novel pilot study is crucial to determine whether treating individuals who are at high risk for transmission or re-infection will impact HCV reinfection rates. This study will establish the feasibility of DAA treatment in corrections facilities, as well as delineate the underlying immune basis of HCV cure and reinfection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HCV Genotype 1, with and without cirrhosis | Other | Drug: Paritaprevir, Drug: Ritonavir, Drug: Dasabuvir, Drug: Ombitasvir, Drug: Ribavirin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- An offender at the PEI Provincial Correction Centre during the enrollment time
- Male, 18 -70 years of age, inclusive, at time of screening
- Chronic HCV genotype 1 infection
- HCV infection, as demonstrated by positive HCV immunosorbant assay and detectable HCV viral load
- No evidence of decompensated liver disease (refractory ascites, variceal bleed within 1 year, active hepatic encephalopathy or Child-Pugh score greater than 6)
Key exclusion criteria (35 listed)
- History of severe, life-threatening or other significant sensitivity to any drug
- Positive test result at screening for Hepatitis B surface antigen
- Prior therapy with direct acting antivirals for the treatment of HCV
- Evidence of decompensated liver disease (current or past refractory ascites, variceal bleed within 1 year, active hepatic encephalopathy)
- HIV positive screening test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paritaprevir | Drug | HCV Genotype 1, with and without cirrhosis |
| Ritonavir | Drug | HCV Genotype 1, with and without cirrhosis |
| Dasabuvir | Drug | HCV Genotype 1, with and without cirrhosis |
| Ombitasvir | Drug | HCV Genotype 1, with and without cirrhosis |
| RibavirinIn genotype 1b individuals without cirrhosis, treatment will NOT include ribavirin. | Drug | HCV Genotype 1, with and without cirrhosis |
Primary outcome
Re-infection rate in individuals treated with DAA therapy
Time frame: 1 year following treatment.
This will require HCV quasispecies determination at baseline and in potentially re-infected individuals. Re-infection will require demonstration of HCV RNA above level of detection after SVR12 with a phyogenetically distinct HCV species.
5 secondary outcomes
Percentage of subjects with sustained virologic response at 12 weeks post treatment
Time frame: 12 Weeks post treatment
Change in fibrosis measured by transient elastography
Time frame: From day 0 to the end of follow-up
Global and HCV-specific T cell function before and after treatment with DAA therapy.
Time frame: From day 0 to end of follow-up
Global and HCV-specific B cell function before and after treatment with DAA therapy.
Time frame: From day 0 to end of follow-up
Global and HCV-specific NK cell function before and after treatment with DAA therapy.
Time frame: From day 0 to end of follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Barrett, MD PhD FRCPC principal investigator
Department of Medicine, Division of Infectious Diseases, Nova Scotia Health Authority, Dalhousie University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Paritaprevir, Ritonavir and Dasabuvir in people with Hepatitis C Virus, run by Nova Scotia Health Authority.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Re-infection rate in individuals treated with DAA therapy (time frame: 1 year following treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.