A Study of Oral Valcyte (Valganciclovir) in Pediatric Kidney Transplant Recipients
| Status: | Completed |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/4/2013 |
| Start Date: | July 2011 |
| End Date: | January 2014 |
| Contact: | Please reference Study ID Number: NV25409 www.roche.com/about_roche/roche_worldwide.htm |
| Email: | genentechclinicaltrials@druginfo.com |
| Phone: | 888-662-6728 (U.S. Only) |
Tolerability of up to 200 Days of Valganciclovir Oral Solution or Tablets in Pediatric Kidney Transplant Recipients
This open-label, single arm study will evaluate the tolerability and efficacy of Valcyte
(valganciclovir) in the prevention of cytomegalovirus infection in pediatric renal
transplant recipients. After transplantation, patients (aged 4 months to 16 years) will
receive Valcyte orally daily for up to 200 days and will be followed for 52 weeks
post-transplantation.
Inclusion Criteria:
- Children, 4 months to 16 years of age
- Patient has received a kidney transplant
- At risk of developing cytomegalovirus disease
- Adequate hematological and renal function
- Able to tolerate oral medication
- Negative pregnancy test for females of childbearing potential
Exclusion Criteria:
- Allergic or significant adverse reaction to acyclovir, valacyclovir or ganciclovir in
the past
- Severe uncontrolled diarrhea (more than 5 watery stools per day)
- Liver enzyme elevation of more than five times the upper limit of normal for AST
(SGOT) or ALT (SGPT)
- Patient requires use of any protocol prohibited concomitant medication
- Previous participation in this clinical study
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