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

Hepatitis C Clinical Trial

Official title:

Pilot Study for the Use of Shortened Preemptive Therapy With Glecaprevir/Pibrentasvir (G/P) and Ezetimibe in Hepatitis C Seronegative Solid Organ Transplant Recipients (Kidney, Heart, Lung and/or Pancreas) of Hepatitis C Viremic Donors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04508907
• Other study ID #: 20-001964
• Status: Recruiting
• Phase: Phase 4
• Start date: September 10, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Mayo Clinic
• Contact: Bashar Aqel
• Phone: 4803420272
• Email: aqel.bashar[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Heart Transplant Infection
• Hepatitis
• Hepatitis A
• Hepatitis C
• Kidney Transplant; Complications

Intervention

Drug:
• Mavyret
Mavyret and Zetia for 8 days to prevent HCV infection in solid organ recipients

Locations

Country	Name	City	State
United States	Mayo Clinic in Arizona	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Graft and patient survival	Study will assess the overall 1 year patient and graft survival.	1 year