Pilot Study of Hepatitis C Virus Entry Inhibitor (ITX 5061) in Liver Transplant Recipients

Hepatitis C Clinical Trial

— ITX5061  

Official title:

Phase I Study of Hepatitis C Virus (HCV) Entry Inhibitor (ITX 5061) in Liver Transplant Recipients With HCV Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01292824
• Other study ID #: RG_10-104
• Secondary ID: 2010-020358-32
• Status: Completed
• Phase: Phase 1
• First received: February 9, 2011
• Last updated: December 1, 2015
• Start date: February 2011
• Est. completion date: May 2013

Study information

• Verified date: December 2015
• Source: University of Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

This is a phase I pilot study to determine the safety and preliminary efficacy of a novel hepatitis C virus (HCV) entry inhibitor (ITX 5061) in patients with HCV infection undergoing liver transplantation.

Description:

Hepatitis C virus (HCV) infection is common and treatment options at present are limited. Recurrence of HCV infection after liver transplantation is inevitable and disease progression is rapid when compared with disease in the non-transplanted liver.

Studies of ITX 5061 in vitro have shown it to be a potent inhibitor of HCV entry into hepatocytes, through blocking the interaction of the virus with scavenger receptor BI suggesting it may reduce graft re-infection rates after liver transplant.

There are no studies of treatments to block host receptors for HCV and the investigators hypothesize that ITX 5061 will modulate HCV kinetics in the early phase post liver transplant.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age = 18 years old, = 65 years old

• Plasma HCV RNA positive at time of listing for liver transplantation

• Accepted for liver transplantation for any of:

• End-stage liver disease due to HCV infection

• End-stage liver disease due to HCV infection and alcohol related liver disease (ALD)

• HCC due to HCV

Exclusion Criteria:

• Refusal or inability to give informed consent

• Viral co-infection with either hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

• Pregnancy or breastfeeding

• Women, of child-bearing potential, who are not willing to practice effective contraception

• Men, sexually active with women of child-bearing potential, who are not willing to practice effective contraception

• Any situation that in the Investigator's opinion may interfere with optimal study participation

• Participation in any clinical study of an investigational agent within 30 days of recruitment

• Transplantation with a donor organ from a HCV positive individual

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Evidence of Liver Transplantation
• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Drug:
• ITX 5061
ITX 5061 (150mg) pre-transplant, immediately post-transplant and daily thereafter for 1 week.

Locations

Country	Name	City	State
United Kingdom	University Hospital Birmingham	Birmingham	West Midlands

Sponsors (3)

Lead Sponsor	Collaborator
University of Birmingham	National Institute for Health Research, United Kingdom, University Hospital Birmingham

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

Rowe IA, Tully DC, Armstrong MJ, Parker R, Guo K, Barton D, Morse GD, Venuto CS, Ogilvie CB, Hedegaard DL, McKelvy JF, Wong-Staal F, Allen TM, Balfe P, McKeating JA, Mutimer DJ. Effect of scavenger receptor class B type I antagonist ITX5061 in patients wi — View Citation

Syder AJ, Lee H, Zeisel MB, Grove J, Soulier E, Macdonald J, Chow S, Chang J, Baumert TF, McKeating JA, McKelvy J, Wong-Staal F. Small molecule scavenger receptor BI antagonists are potent HCV entry inhibitors. J Hepatol. 2011 Jan;54(1):48-55. doi: 10.1016/j.jhep.2010.06.024. Epub 2010 Aug 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the safety of ITX 5061 in liver transplant recipients	Safety will be assessed by determination of the frequency of: perioperative events: including transfusion requirements and vasopressor requirements; post-operative events: including primary graft non-function, hepatic artery thrombosis, acute cellular rejection and infective complications	90 days	Yes
Secondary	To determine whether treatment leads to an alteration in HCV RNA kinetics in the first week after liver transplantation	Hepatitis C virus titers will be measured at multiple times in the peri- and immediate post-operative period and kinetics assessed at 7 days after liver transplant.	One week	No
Secondary	To determine whether any change in early viral kinetics is sustained	Hepatitis C virus titers will be measured at multiple times in the post-operative period and kinetics assessed at 90 days after liver transplant.	90 days	No