Direct-acting Antiviral Therapy to Prevent HCV Infection for HCV Positive Donor to HCV Negative Recipient Kidney Transplant

Hepatitis C Clinical Trial

Official title:

Use of Direct-acting Antiviral Therapy to Prevent Spread of HCV Infection for Patients Receiving a HCV Positive Kidney Transplant as a HCV Negative Recipient

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03093740
• Other study ID #: 2017P000301
• Status: Withdrawn
• Phase: Phase 4
• Start date: October 1, 2018
• Est. completion date: January 31, 2021

Study information

• Verified date: December 2018
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Open label single center study for the donation of HCV positive kidneys to HCV negative recipients with interventional treatment to prevent HCV transmission upon transplantation.

Description:

The study objective is to determine if the administration of direct acting antivirals for 12-16 weeks after kidney transplantation prevents the spread of HCV infection from donor kidney with known HCV infection (all genotypes) to an HCV negative recipient as evidenced by a negative HCV viral RNA at 12 weeks post treatment.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

• Donor meets MGH transplant center criteria and already listed for isolated kidney transplant

• No available living kidney donor

• Recipient has = 730 days of accrued transplant waiting time

• Recipient chronic hemodialysis or peritoneal dialysis

• Recipient must agree to birth control.

°.Weigh = 50kg

• Serum ALT within normal limits

• Subject's Insurance company approves payment for DAA therapy post-kidney transplant

Exclusion Criteria:

• AB Blood type

• HCV genotype 1

• BMI > 35

• Any liver disease in recipient

• Pregnant or nursing (lactating) women

• Known allergy or intolerance to tacrolimus that would require administration of cyclosporine

• Albumin < 3g/dl or

• Platelet count < 75 x 103/mL

• Positive crossmatch or positive donor specific antibodies

• HCV RNA positive

• Hepatitis B surface antigen positive

• Patients with primary focal segmental glomerulosclerosis (FSGS)

• Any contra-indication to kidney transplantation per our center protocol

Related Conditions & MeSH terms

• Hepatitis C
• Kidney Failure, Chronic
• Renal Failure Chronic
• Renal Insufficiency

Intervention

Drug:
• Zepatier
Based on negative viral resistance testing of the donor treatment will be Zepatier
• Zepatier plus Sofosbuvir
Based on positive viral resistance testing of the donor treatment will be Zepatier with Sofosbuvir

Locations

Country	Name	City	State
United States	Massachusetts 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	Undetectable HCV RNA	Negative HCV viral load 12 weeks after last dose of treatment	12 weeks post treatment