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

Phase 1

• Conditions: Treatment and prevention of CMV disease in kidney transplant recipients; MedDRA version: 16.0Level: LLTClassification code 10049107Term: CMV viraemiaSystem Organ Class: 100000004862; MedDRA version: 16.0Level: LLTClassification code 10009703Term: CMV infectionSystem Organ Class: 100000004862; MedDRA version: 16.0Level: LLTClassification code 10009701Term: CMVSystem Organ Class: 100000004848; MedDRA version: 16.0Level: LLTClassification code 10060577Term: CMV viremiaSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-05-17
• Study Completion: 2013-05-23
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 57

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, valacyclovir, 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 study.

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

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

Study & Design

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