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

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ClinicalTrials.gov Identifier: NCT03364725
Recruitment Status : Not yet recruiting
First Posted : December 7, 2017
Last Update Posted : December 7, 2017
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Ronald Nahass, Id Care

December 1, 2017
December 7, 2017
December 7, 2017
January 15, 2018
September 1, 2018   (Final data collection date for primary outcome measure)
Cure rate of Hepatitis C Infection [ Time Frame: 12 weeks after treatment completion viral load measure ]
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
Same as current
No Changes Posted
  • Sobriety from Drug Use [ Time Frame: 1 year ]
    Rate of sobriety maintenance for 1 year after enrollment
  • Hepatitis C Reinfection Rate [ Time Frame: 1 year ]
    Re-infection rate with HCV over 1 year after enrollment
Same as current
Not Provided
Not Provided
 
Toward Elimination of Hepatitis C Virus (HCV): A Pilot Study
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
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.

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:

  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
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Hepatitis C
  • Addict Heroin
Drug: Glecaprevir-pibrentasvir
Glecaprevir-pibrentasvir will be dispensed to 30 patients recently detoxed off heroin in an acute detox center.
Experimental: Open Label Treatment Arm
Treatment arm using Glecaprevir-pibrentasvir for treatment of all patients
Intervention: Drug: Glecaprevir-pibrentasvir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
30
Same as current
March 1, 2019
September 1, 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 30 Years   (Adult)
No
Contact: Ronald Nahass, MD 9082810221 rnahass@idcare.com
Contact: Kathleen Seneca, MSN, APN 9082810221 kseneca@idcare.com
United States
 
 
NCT03364725
IIS # 11-507
No
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
Plan to Share IPD: No
Ronald Nahass, Id Care
Id Care
AbbVie
Principal Investigator: Ronald Nahass, MD Id Care
Id Care
December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP