Prevention of Cytomegalovirus (CMV) disease in liver transplant patients: studies of antiviral prophylaxis and pre-emptive therapy.

Phase 4

Completed

• Conditions: CMV and liver transplantation; Infection - Other infectious diseases; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12610000787088
• Lead Sponsor: Austin Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-09-22
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Male or female > 16 years of age
2. Patients undergoing liver transplantation
3. Single or multi-organ transplant
4. Patients meet transplant criteria
5. Chronic liver disease or fulminant hepatic failure
6. Able to give written informed consent

Exclusion Criteria

1. Patients under the age of 16 years
2. History of hypersensitivity to ganciclovir or valganciclovir
3. Patients involved in any other clinical trials
4. Patients taking any other investigational drugs within 2 months prior to the study screening.
5. Use of any other antiviral therapy against herpes virus within 2 months prior to transplant will be noted and this population analysed as a subgroup
6. Patients unable to give consent
7. Inadequate renal function defined as creatinine clearance < 10 mL/sec

Study & Design

• Study Type: Interventional
• Study Design: Not specified