Toward Elimination of Hepatitis C Virus (HCV): A Pilot Study
NCT ID: NCT03364725
Last Updated: 2017-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
30 participants
INTERVENTIONAL
2018-01-15
2019-03-01
Brief Summary
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Detailed Description
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Primary objective:
1\. Cure rates (SVR-12, HCV plasma RNA not quantifiable 12 weeks after last dose of treatment) of HCV in 30 recently identified PWIDS under 30 years old
Secondary objectives:
1. Rate of sobriety maintenance for 1 year after enrollment
2. Re-infection rate with HCV over 1 year after enrollment
3. Re-admission rates for detox
4. Cravings
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Open Label Treatment Arm
Treatment arm using Glecaprevir-pibrentasvir for treatment of all patients
Glecaprevir-pibrentasvir
Glecaprevir-pibrentasvir will be dispensed to 30 patients recently detoxed off heroin in an acute detox center.
Interventions
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Glecaprevir-pibrentasvir
Glecaprevir-pibrentasvir will be dispensed to 30 patients recently detoxed off heroin in an acute detox center.
Eligibility Criteria
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Inclusion Criteria
* Successfully detoxed at PHBH from opioids
* Agree to participate in a closely monitored program
* Positive HCV VL \> 5,000 on two tests
* Minimum one follow-up visit after discharge from PHBH to be enrolled
* Any genotype
* APRI less than 1 and Fibrosure less than 0.45
* Negative pregnancy test in women and females must agree to acceptable contraception during treatment of HCV. Oral contraceptives that do not contain ethinyl estradiol are allowed with Mavyret
* Treatment naïve for HCV
* Signed informed consent
Exclusion Criteria
* Co-infection with HIV or HBV
* Inability to comply with treatment or follow up
* Renal failure with GFR less than 50 mL/min5\*
* Any prior treatment for HCV
* Diabetes with HgA1c more than 8.0
* Clinically significant abnormalities, other than HCV infection, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram (ECG) that make the subject an unsuitable candidate for this study in the opinion of the investigator, including, but not limited to:
* ALT/AST \> 10x normal value,
* WBC with ANC \< 1500 cell/ul,
* Hemoglobin \< LLN,
* Treatment for cancer or lymphoma in the past 5 years,
* Hemoglobin A 1C \> 8%.
* Any uncontrolled psychiatric, cardiac, respiratory, gastrointestinal, hematologic, neurologic, psychiatric, or other medical disease or disorder, which is unrelated to the existing HCV infection which in the opinion of the PI would prevent adherence to and participation in the trial.
* Hypersensitivity to naltrexone or polylactide-co-glycolide (PLG) microspheres
18 Years
30 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Id Care
OTHER
Responsible Party
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Ronald Nahass
Principle Invesigator
Principal Investigators
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Ronald Nahass, MD
Role: PRINCIPAL_INVESTIGATOR
Id Care
Locations
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ID CARE
Hillsborough, New Jersey, United States
Countries
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Central Contacts
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Facility Contacts
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Ronald Nahass, MD
Role: primary
Kathleen Seneca, MSN, APN
Role: backup
Other Identifiers
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IIS # 11-507
Identifier Type: -
Identifier Source: org_study_id