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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03086044
Other study ID # 2016-P001170
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date March 1, 2017
Est. completion date December 2023

Study information

Verified date October 2022
Source Brigham and Women's Hospital
Contact Ann Woolley, MD
Phone 617-732-5500
Email awoolley@bwh.harvard.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Description:

This is an open label pilot study transplanting organs from Hepatitis C positive donors into HCV uninfected recipients at Brigham and Women's Hospital. Heart, lung and kidney transplant participants will be stratified into two different study arms depending on whether the donor of the organ was HCV nucleic acid amplifications technology (NAT) positive or negative. In the NAT positive arm, the recipients will receive a course of direct acting antivirals (DAA) to begin on the day of transplant. If the donor was HCV antibody (Ab) positive and NAT negative, the recipients will receive close monitoring with serial HCV viral loads (VL) and will only begin treatment with DAA if they develop HCV viremia.


Recruitment information / eligibility

Status Recruiting
Enrollment 148
Est. completion date December 2023
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Hepatitis B NAT or viral load positive - Evidence of cirrhosis or clinically significant liver disease

Study Design


Intervention

Drug:
Sofosbuvir/velpatasvir
2 weeks of treatment beginning on the day of transplant
Other:
Monitoring
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

Locations

Country Name City State
United States Brigham and Women's Hospital Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Graft survival Functioning allograft not requiring mechanical support 6 months post-transplant
Primary 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 Treatment related adverse events Number of treatment related adverse events per patient using direct-acting antiviral HCV regimens in post transplant recipients 6 months post-transplant
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