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Toward Elimination of Hepatitis C Virus (HCV): A Pilot Study (ELIMINATEC)

Primary Purpose

Hepatitis C, Addict Heroin

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Glecaprevir-pibrentasvir
Sponsored by
Id Care
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18 - 30
  • 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:

  • Cirrhosis
  • 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

Sites / Locations

  • ID CARE

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Open Label Treatment Arm

Arm Description

Treatment arm using Glecaprevir-pibrentasvir for treatment of all patients

Outcomes

Primary Outcome Measures

Cure rate of Hepatitis C Infection
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

Secondary Outcome Measures

Sobriety from Drug Use
Rate of sobriety maintenance for 1 year after enrollment
Hepatitis C Reinfection Rate
Re-infection rate with HCV over 1 year after enrollment

Full Information

First Posted
December 1, 2017
Last Updated
December 6, 2017
Sponsor
Id Care
Collaborators
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT03364725
Brief Title
Toward Elimination of Hepatitis C Virus (HCV): A Pilot Study
Acronym
ELIMINATEC
Official Title
Toward Elimination of Hepatitis C Virus (HCV): A Pilot Study Combining HCV and Addiction Treatment of Young Suburban Heroin Users (SHU) That Addresses Barriers to Care
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 15, 2018 (Anticipated)
Primary Completion Date
September 1, 2018 (Anticipated)
Study Completion Date
March 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Id Care
Collaborators
AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To demonstrate that colocation treatment of substance use disorder and Hepatitis C infection concurrently while proving addiction counselling will achieve increased duration of sobriety and elimination of Hepatitis C virus in study participants.
Detailed Description
To demonstrate that colocation treatment of substance use disorder and Hepatitis C infection concurrently while proving addiction counselling will achieve increased duration of sobriety and elimination of Hepatitis C virus in study participants. 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: Rate of sobriety maintenance for 1 year after enrollment Re-infection rate with HCV over 1 year after enrollment Re-admission rates for detox Cravings

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Addict Heroin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Open Label Treatment Arm
Arm Type
Experimental
Arm Description
Treatment arm using Glecaprevir-pibrentasvir for treatment of all patients
Intervention Type
Drug
Intervention Name(s)
Glecaprevir-pibrentasvir
Intervention Description
Glecaprevir-pibrentasvir will be dispensed to 30 patients recently detoxed off heroin in an acute detox center.
Primary Outcome Measure Information:
Title
Cure rate of Hepatitis C Infection
Description
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
Time Frame
12 weeks after treatment completion viral load measure
Secondary Outcome Measure Information:
Title
Sobriety from Drug Use
Description
Rate of sobriety maintenance for 1 year after enrollment
Time Frame
1 year
Title
Hepatitis C Reinfection Rate
Description
Re-infection rate with HCV over 1 year after enrollment
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 - 30 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: Cirrhosis 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ronald Nahass, MD
Phone
9082810221
Email
rnahass@idcare.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kathleen Seneca, MSN, APN
Phone
9082810221
Email
kseneca@idcare.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald Nahass, MD
Organizational Affiliation
Id Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
ID CARE
City
Hillsborough
State/Province
New Jersey
ZIP/Postal Code
08844
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronald Nahass, MD
Phone
908-281-0221
Email
rnahass@idcare.com
First Name & Middle Initial & Last Name & Degree
Kathleen Seneca, MSN, APN
Phone
9082810221
Email
kseneca@idcare.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Toward Elimination of Hepatitis C Virus (HCV): A Pilot Study

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