ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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

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.

Condition or disease Intervention/treatment Phase
Hepatitis C Addict Heroin Drug: Glecaprevir-pibrentasvir Phase 4

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:

  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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : January 15, 2018
Estimated Primary Completion Date : September 1, 2018
Estimated Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Open Label Treatment Arm
Treatment arm using Glecaprevir-pibrentasvir for treatment of all patients
Drug: Glecaprevir-pibrentasvir
Glecaprevir-pibrentasvir will be dispensed to 30 patients recently detoxed off heroin in an acute detox center.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Sobriety from Drug Use [ Time Frame: 1 year ]
    Rate of sobriety maintenance for 1 year after enrollment

  2. Hepatitis C Reinfection Rate [ Time Frame: 1 year ]
    Re-infection rate with HCV over 1 year after enrollment



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03364725


Contacts
Contact: Ronald Nahass, MD 9082810221 rnahass@idcare.com
Contact: Kathleen Seneca, MSN, APN 9082810221 kseneca@idcare.com

Locations
United States, New Jersey
ID CARE Not yet recruiting
Hillsborough, New Jersey, United States, 08844
Contact: Ronald Nahass, MD    908-281-0221    rnahass@idcare.com   
Contact: Kathleen Seneca, MSN, APN    9082810221    kseneca@idcare.com   
Sponsors and Collaborators
Id Care
AbbVie
Investigators
Principal Investigator: Ronald Nahass, MD Id Care

Responsible Party: Ronald Nahass, Principle Invesigator, Id Care
ClinicalTrials.gov Identifier: NCT03364725     History of Changes
Other Study ID Numbers: IIS # 11-507
First Posted: December 7, 2017    Key Record Dates
Last Update Posted: December 7, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: 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

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections