NCT03086044

Brief Summary

This is an open-label, pilot safety and efficacy trial for adults who are active on the heart, lung, or kidney transplantation lists and are eligible to receive an organ from an increased risk donor who has evidence of active or prior hepatitis C infection (HCV).

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
148

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2017

Longer than P75 for phase_4

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

September 12, 2016

Completed
6 months until next milestone

Study Start

First participant enrolled

March 1, 2017

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 22, 2017

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

October 12, 2022

Status Verified

October 1, 2022

Enrollment Period

6.8 years

First QC Date

September 12, 2016

Last Update Submit

October 10, 2022

Conditions

Hepatitis CAwaiting Organ Transplant

Outcome Measures

Primary Outcomes (2)

  • Graft survival

    Functioning allograft not requiring mechanical support

    6 months post-transplant

  • HCV status of the transplant recipient

    Sustained virologic response (SVR) 12 weeks after HCV treatment completion in Arm A or at 6 months in Arm B (SVR defined as HCV RNA \< lower limit of quantification)

    6 months post-transplant

Secondary Outcomes (1)

  • Treatment related adverse events

    6 months post-transplant

Study Arms (2)

HCV NAT Positive Donor

EXPERIMENTAL

Intervention: 2 week treatment course with a direct acting antiviral, sofosbuvir 400mg / velpatasvir 100mg daily Participants who receive allografts from a donor who is HCV NAT positive will receive treatment with a direct acting antiviral, sofosbuvir 400mg / velpatasvir 100mg daily, beginning on the day of transplant.

Drug: Sofosbuvir/velpatasvir

HCV NAT Negative, HCV Ab Positive Donor

EXPERIMENTAL

Intervention: HCV viral load monitoring Participants who receive allografts from a donor who is HCV Ab positive and NAT negative will have close serial HCV viral load monitoring and will be treated with a direct acting antiviral, 400mg / velpatasvir 100mg daily, for 6 weeks if HCV viremia develops.

Drug: Sofosbuvir/velpatasvirOther: Monitoring

Interventions

Sofosbuvir/velpatasvirDRUG

2 weeks of treatment beginning on the day of transplant

Also known as: Epclusa
HCV NAT Negative, HCV Ab Positive DonorHCV NAT Positive Donor
MonitoringOTHER

Close HCV viral load monitoring Will receive direct acting antiviral treatment with 6 weeks of sofosbuvir/velpatasvir if the recipient develops HCV viremia during the post-transplant HCV viral load testing

Also known as: Sofosbuvir/velpatasvir (Epclusa)
HCV NAT Negative, HCV Ab Positive Donor

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women who are age ≥ 18 years
  • Active on either the cardiac, lung, or kidney transplant waiting list
  • Willing and able to provide written informed consent to receive organs from an increased risk donor with a known transmissible infection

You may not qualify if:

  • Hepatitis B NAT or viral load positive
  • Evidence of cirrhosis or clinically significant liver disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Related Publications (1)

  • Woolley AE, Singh SK, Goldberg HJ, Mallidi HR, Givertz MM, Mehra MR, Coppolino A, Kusztos AE, Johnson ME, Chen K, Haddad EA, Fanikos J, Harrington DP, Camp PC, Baden LR; DONATE HCV Trial Team. Heart and Lung Transplants from HCV-Infected Donors to Uninfected Recipients. N Engl J Med. 2019 Apr 25;380(17):1606-1617. doi: 10.1056/NEJMoa1812406. Epub 2019 Apr 3.

    PMID: 30946553DERIVED

MeSH Terms

Conditions

Hepatitis C

Interventions

sofosbuvir-velpatasvir drug combinationSofosbuvirvelpatasvir

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Uridine MonophosphateUracil NucleotidesPyrimidine NucleotidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleotidesNucleic Acids, Nucleotides, and NucleosidesRibonucleotides

Study Officials

  • Lindsey Baden, MD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ann Woolley, MD

CONTACT

617-732-5500awoolley@bwh.harvard.edu

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor at Harvard Medical School

Study Record Dates

First Submitted

September 12, 2016

First Posted

March 22, 2017

Study Start

March 1, 2017

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

October 12, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)