Eliminating Hepatitis C Virus | NCT03401697

Studies
Eliminating Hepatitis C Virus

NCT03401697

Sponsor

Icahn School of Medicine at Mount Sinai

Status

Completed

Last Update Posted

Mar 24, 2021Actual

Enrollment

52Actual

Phase

Not provided

Conditions

Hepatitis C
HIV
Type2 Diabetes

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 23, 2018Actual

Primary Completion Date

Mar 1, 2021Actual

Completion Date

Mar 1, 2021Actual

First Submitted Date

Jan 9, 2018

First Submission Date that Met QC Criteria

Jan 16, 2018

First Posted Date

Jan 17, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 23, 2021

Last Update Posted Date

Mar 24, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Initially, HCV Informatics (C-IT) will be used to filter the EMR data of the one million people who receive care at Mount Sinai and identify candidates for HCV testing (baby boomers, patients with HIV infection) and candidates for HCV treatment (patients with positive test results for HCV RNA and no record of treatment).once treatment candidates have been identified through this proactive approach, their providers will be directly notified. HCV champions and patient navigators will be used to further lower barriers to the delivery of HCV care. They will be co-located at non-hepatology care sites and will help deliver open-label HCV treatment as part of standard medical care to 500 HIV/HCV co-infected patients and 200 patients with type 2 diabetes.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

52Actual

Label	Type	Description	Intervention Names
HIV/HCV Co-infected		Patients with HIV/HCV co-infection
Type 2 Diabetes		Patients with Type 2 Diabetes

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in the Number of Patients with sCD163 above the upper limit of normal	Change in the Number of Patients with sCD163 above the upper limit of normal at 3 years from baseline	baseline and 3 years
Number of Type 2 Diabetes patients that initiate HCV treatment	The number of patients that initiate HCV treatment per month per patient navigator.	3 years

Secondary Outcomes

Measure	Description	Time Frame
sCD163	blood sample for sC163, a marker of systemic inflammation.	3 years
Percentage of patients in need of repeated re-treatment	The percentage of patients in need of repeated re-treatment whose quasispecies analysis indicates that re-infection is the likely cause of recurrent HCV viremia. If such patients are identified, they will be referred for risk reduction counseling.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Inclusion criteria for HCV treatment in patients with HIV/HCV co-infection

18 years of age or older
HCV RNA positive
Any HCV genotype
Documented infection with HIV, with the following additional criteria: - Patients on HAART should be on a stable regimen for 4 weeks, with a CD4 count > 100, and an HIV viral load < 50 prior to initiation of HCV therapy Patients not on HAART should have a CD4 count > 350
Expected life expectancy sufficient to receive a benefit from HCV cure
No conditions that are contraindications for the use of HCV medications

Inclusion criteria for HCV treatment in patients with type 2 diabetes

18 years of age or older
HCV RNA positive
Any HCV genotype
Documented diagnosis of type 2 diabetes, confirmed by medical record review by the study endocrinologist, Dr. Sherley Abraham
Expected life expectancy sufficient to receive a benefit from HCV cure

Exclusion Criteria:

No conditions that are contraindications for the use of HCV medications

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

People who receive care at Mount Sinai and candidates for HCV testing or HCV treatment and co-located at non-hepatology care sites.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Andrea D. Branch, PhD	Icahn School of Medicine at Mount Sinia	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Icahn School of Medicine at Mount Sinai		New York	New York	10029	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Direct outreach to providers (giving them the names of their patients who are candidates for treatment)

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D006526	Hepatitis C

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D006525	Hepatitis, Viral, Human

Description

Blood (10 mL) will be collected from 100 HIV/HCV coinfected patients before and after HCV cure. sCD163 will be measured using the human CD163 Quantkine ELISA kit from R and D systems. Blood (10 mL) will also be collected from up to 50 patients who fail therapy or become reinfected with HCV. The HCV RNA quasispecies will be analyzed using the deep sequencing methods. Serum will be saved for HIV/HCV Co-infected.