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

• ClinicalTrials.gov Identifier: NCT03364725
• Recruitment Status: Unknown
• First Posted: December 7, 2017
• Last Update Posted: December 7, 2017
• Sponsor: Id Care
• Collaborator: AbbVie
• Information provided by (Responsible Party): Ronald Nahass, Id Care

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.

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 30 participants
• Allocation: N/A
• 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

Arms and Interventions

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.

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

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

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

More Information

• Responsible Party: Ronald Nahass, Principle Invesigator, Id Care
• ClinicalTrials.gov Identifier: NCT03364725
• Other Study ID Numbers: IIS # 11-507
• First Posted: December 7, 2017
• 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 A; Hepatitis C; Hepatitis; Liver Diseases; Digestive System Diseases; Hepatitis, Viral, Human; Virus Diseases; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Flaviviridae Infections