DAA Treatment in Donor HCV-positive to Recipient HCV-negative Liver Transplant

Hepatitis C Clinical Trial

Official title:

Pan-genotypic Direct Acting Antiviral Therapy in Donor HCV-positive to Recipient HCV-negative Liver Transplant

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03208127
• Other study ID #: 2017P000653
• Status: Terminated
• Phase: Phase 4
• Start date: November 21, 2017
• Est. completion date: June 4, 2021

Study information

• Verified date: July 2022
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a single center study for the donation of Hepatitis C Virus (HCV)-positive livers to HCV negative recipient patients, with preemptive, interventional treatment to prevent HCV transmission upon transplantation.

Description:

Patients will be selected based on diminished likelihood of receiving a liver from the waitlist within a period during which they would be likely to succumb to severe comorbidities. This will be determined in part through use of a patient's Model of End Stage Liver Disease (MELD) score, listing status, and clinical judgment. To ensure maximal benefit for the recipient, only high quality donor livers will be accepted.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 33
• Est. completion date: June 4, 2021
• Est. primary completion date: June 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Recipient is Age = 18 years
• Met Massachusetts General Hospital (MGH) transplant center criteria, listed for liver transplant
• HCV naïve
• Able to sign informed consent

Exclusion Criteria:

• Pregnant or nursing (lactating) women
• Human immunodeficiency virus (HIV) positivity
• Need for dual organ transplant
• Any contra-indication to liver transplantation per center protocol

Related Conditions & MeSH terms

• End Stage Liver Disease
• Hepatitis C
• Liver Diseases

Intervention

Drug:
• Treatment with Direct Acting Antiviral tablet
HCV Treatment for 12 Weeks

Locations

Country	Name	City	State
United States	Masschusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Undetectable Hepatitis C Virus (HCV) Viral RNA	Number of dosed subjects with negative HCV viral RNA at 12 weeks after the last dose of treatment.	12 weeks post treatment
Secondary	Number of Participants With Treatment Emergent Adverse Events and Out of Range Lab Values	Safety and tolerability of direct acting antiviral therapy in the liver transplant patient will be monitored by quantifying the number of treatment related adverse events per patient and evaluating clinically significant out of range laboratory results as compared to baseline/pretreatment values per patient.	12 weeks