A Study to Evaluate Preemptive Therapy in Hepatitis C (HC... | NCT04508907

Studies
A Study to Evaluate Preemptive Therapy in Hepatitis C (HCV) Organ Transplant Recipients

NCT04508907

Sponsor

Mayo Clinic

Status

Active, not recruiting

Last Update Posted

Dec 17, 2025Actual

Enrollment

200Estimated

Phase

Phase 4

Conditions

Hepatitis C
Kidney Transplant; Complications
Heart Transplant Infection

Interventions

Mavyret

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

Dec 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 10, 2020Actual

Primary Completion Date

Nov 1, 2025Actual

Completion Date

Nov 1, 2026Estimated

First Submitted Date

Jul 30, 2020

First Submission Date that Met QC Criteria

Aug 7, 2020

First Posted Date

Aug 11, 2020Actual

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

Dec 15, 2025

Last Update Posted Date

Dec 17, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

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

This study is being done to determine the effectiveness of using a combination of two different drugs in preventing the transmission of HCV from a HCV positive donor to a HCV negative solid organ recipient.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1: Pre-emptive Treatment Arm	Experimental	Single arm study were all recipients of HCV viremic organs will receive combination therapy.	Drug: Mavyret

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mavyret	Drug	Mavyret and Zetia for 8 days to prevent HCV infection in solid organ recipients	Arm 1: Pre-emptive Treatment Arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of prevention of HCV viremia in recipients of HCV viremic solid organs	The study will assess the percentage of patient who will not become HCV viremic using this preemptive treatment protocol.	3 months
Graft and patient survival	Study will assess the overall 1 year patient and graft survival.	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Listed kidney, heart, lung and/or pancreas patients who are negative for chronic hepatitis C infection
Willing to accept and consent for accepting hepatitis C positive graft

Exclusion criteria:

Existing chronic liver disease (liver cirrhosis)
Concomitant infection with HIV or Chronic hepatitis B
Patient or any member of patient family or care giver team who does not understand or accept the risk of an acquired HCV infection
Pregnancy (Pregnant patients do not undergo solid organ transplants)

Accepts Healthy Volunteers

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bashar A Aqel	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic in Arizona		Phoenix	Arizona	85054	United States

Label	URL
Mayo Clinic Clinical Trials	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006526	Hepatitis C

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000654128	glecaprevir and pibrentasvir
D000069438	Ezetimibe

Ancestor Terms

ID	Term
D001384	Azetidines
D001385	Azetines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided