- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02460133
Understanding HCV Reinfection Rates in an Incarcerated Population After Cure With Interferon Free HCV Treatment
Understanding HCV Reinfection Rates in an Incarcerated Population After Cure With Interferon Free HCV Treatment: A Pilot Project
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
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
Exclusion Criteria:
- 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
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: HCV Genotype 1, with and without cirrhosis
|
In genotype 1b individuals without cirrhosis, treatment will NOT include ribavirin.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 year following treatment.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of subjects with sustained virologic response at 12 weeks post treatment
Time Frame: 12 Weeks post treatment
|
12 Weeks post treatment
|
Change in fibrosis measured by transient elastography
Time Frame: From day 0 to the end of follow-up
|
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
|
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
|
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
|
From day 0 to end of follow-up
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Lisa Barrett, MD PhD FRCPC, Department of Medicine, Division of Infectious Diseases, Nova Scotia Health Authority, Dalhousie University
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Disease Attributes
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Hepatitis
- Recurrence
- Hepatitis C
- Reinfection
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Antimetabolites
- Protease Inhibitors
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- HIV Protease Inhibitors
- Viral Protease Inhibitors
- Ribavirin
- Ritonavir
Other Study ID Numbers
- SAIL-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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