NCT03364725

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 7, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

January 15, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

December 7, 2017

Status Verified

December 1, 2017

Enrollment Period

8 months

First QC Date

December 1, 2017

Last Update Submit

December 6, 2017

Conditions

Hepatitis CAddict Heroin

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Sobriety from Drug Use

    1 year

  • Hepatitis C Reinfection Rate

    1 year

Study Arms (1)

Open Label Treatment Arm

EXPERIMENTAL

Treatment arm using Glecaprevir-pibrentasvir for treatment of all patients

Drug: Glecaprevir-pibrentasvir

Interventions

Glecaprevir-pibrentasvirDRUG

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

Open Label Treatment Arm

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ID CARE

Hillsborough, New Jersey, 08844, United States

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

glecaprevir and pibrentasvir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Ronald Nahass, MD

    Id Care

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ronald Nahass, MD

CONTACT

9082810221rnahass@idcare.com

Kathleen Seneca, MSN, APN

CONTACT

9082810221kseneca@idcare.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Invesigator

Study Record Dates

First Submitted

December 1, 2017

First Posted

December 7, 2017

Study Start

January 15, 2018

Primary Completion

September 1, 2018

Study Completion

March 1, 2019

Last Updated

December 7, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)