Assessment of the acceptability of up to 200 Days of Valganciclovir Oral Solution or Tablets in children who have received a Kidney Transplant

• Conditions: Treatment and prevention of CMV disease in kidney transplant recipients; MedDRA version: 14.1Level: LLTClassification code 10049107Term: CMV viraemiaSystem Organ Class: 100000004862; MedDRA version: 14.1Level: LLTClassification code 10009703Term: CMV infectionSystem Organ Class: 100000004862; MedDRA version: 15.1Level: LLTClassification code 10009701Term: CMVSystem Organ Class: 100000004848; MedDRA version: 14.1Level: LLTClassification code 10060577Term: CMV viremiaSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2010-022514-47-DE
• Lead Sponsor: F. Hoffmann-La Roche Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-20
• Last Update Posted: 3 February 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Parent or guardian of patient willing and able to give written informed consent; the written assent from the child is also required if he/she is old enough to understand the risks and benefits of the study.

2. Patient has received a kidney transplant.

3. Males or females aged between 4 months and = 16 years.

4. Patient at risk of developing CMV disease (including R+ who are at
risk of CMV due to other factors determined by the treating
physician).

5. Patient has adequate hematological and renal function defined as:
• Absolute neutrophil count (ANC) >1300 cells/µL
• Platelet count >40,000 cells/µL
• Hemoglobin >8.0 g/dL
• Estimated Schwartz creatinine clearance (>15 mL/min) to allow for dosing according to algorithm

6. Patient is able to tolerate oral medication (any standard practice tube
feeding is acceptable).

7. Negative pregnancy test (blood or urine) for females of child bearing
potential before initiation of valganciclovir treatment.

8. Patients of reproductive potential agree to utilize an effective method
of contraception throughout the study period and for 90 days following discontinuation of study drug (abstinence is a valid method of contraception).
Are the trial subjects under 18? yes
Number of subjects for this age range: 50
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patient has exhibited an allergic or other significant adverse reaction to acyclovir, valaciclovir, ganciclovir or valganciclovir (or excipients) in the past.

2. Patient has severe, uncontrolled diarrhea (more than 5 watery stools
per day).

3. Patient has liver enzyme elevation of more than five times the upper
limit of normal for AST (SGOT) or ALT (SGPT).

4. Patient requires use of any protocol prohibited concomitant
medications.

5. Patient has previously participated in this clinical trial.

6. Patient is a lactating female who will not discontinue nursing prior to
study entry.

7. Patient is simultaneously participating in another clinical trial except as approved by the Sponsor.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: • The primary objective of this study is to describe the tolerability profile of up to 200 days prophylaxis of valganciclovir oral solution and tablets in pediatric kidney transplant recipients.;Secondary Objective: • To describe the incidence of CMV infection (viremia) and disease (CMV syndrome or tissue invasive CMV) within the first 52 weeks post transplant.<br><br>• To describe the incidence and nature of CMV resistance to ganciclovir (mutations in UL97 and/or UL54).;Primary end point(s): To describe the tolerability profile of up to 200 days prophylaxis of valganciclovir oral solution and tablets in pediatric kidney transplant recipients;Timepoint(s) of evaluation of this end point: Up to 52 weeks post-transplant

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): To describe the incidence of CMV infection and disease within the first 52 weeks post-transplant<br><br>To describe the incidence and nature of resistance to ganciclovir;Timepoint(s) of evaluation of this end point: Up to 52 weeks post-transplant<br>