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Health Condition(s) or Problem
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Cytomegalovirus Infections, Kidney Transplantation
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Lay Summary
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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.
(from ClinicalTrials.gov)
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Who can enter the trial
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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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Who cannot enter the trial
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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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What will happen
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Drug; valganciclovir [Valcyte]; orally daily for up to 200 days; Single arm
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Primary aim
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Tolerability: Incidence of adverse events
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Secondary Aim
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Incidence of cytomegalovirus infection or disease in the first 52 weeks post-transplant; 52 weeks; No; Incidence of resistance to ganciclovir (mutations in both UL54 and UL97 genes); week 28; No
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Participant Information Sheet
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Sorry, not currently available
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Website
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Sorry, not currently available
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Recruitment Status
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Not Recruiting
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Nation
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England, Scotland
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Location
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Birmingham, Bristol, Glasgow
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