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

Hepatitis C Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03364725
• Other study ID #: IIS # 11-507
• Status: Not yet recruiting
• Phase: Phase 4
• First received: December 1, 2017
• Last updated: December 6, 2017
• Start date: January 15, 2018
• Est. completion date: March 1, 2019

Study information

• Verified date: December 2017
• Source: Id Care
• Contact: Ronald Nahass, MD
• Phone: 9082810221
• Email: rnahass[@]idcare.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: March 1, 2019
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Addict Heroin
• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Drug:
• Glecaprevir-pibrentasvir
Glecaprevir-pibrentasvir will be dispensed to 30 patients recently detoxed off heroin in an acute detox center.

Locations

Country	Name	City	State
United States	ID CARE	Hillsborough	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Id Care	AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 weeks after treatment completion viral load measure
Secondary	Sobriety from Drug Use	Rate of sobriety maintenance for 1 year after enrollment	1 year
Secondary	Hepatitis C Reinfection Rate	Re-infection rate with HCV over 1 year after enrollment	1 year