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A Study of Oral Valcyte (Valganciclovir) in Pediatric Kidney Transplant Recipients

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Kidney Transplantation, Cytomegalovirus Infections

Intervention: valganciclovir [Valcyte] (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche

Summary

This open-label, single arm study will evaluate the tolerability and efficacy of Valcyte (valganciclovir) in the prevention of cytomegalovirus disease in pediatric renal transplant recipients. After transplantation, patients (aged 4 months to 16 years) will receive Valcyte orally daily for up to 200 days post-transplant and will be followed for 52 weeks post-transplantation.

Clinical Details

Official title: Tolerability of up to 200 Days of Valganciclovir Oral Solution or Tablets in Pediatric Kidney Transplant Recipients

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) or Withdrawal Due to AEs

Secondary outcome:

Number of Participants With Cytomegalovirus (CMV) Infection in the First 52 Weeks Post-Transplant as Assessed by the Investigator

Number of Participants With Cytomegalovirus (CMV) Disease in the First 52 Weeks Post-Transplant as Assessed by the Investigator

Number of Participants With Peak Cytomegalovirus (CMV) Viral Load up to Week 52 Post-Transplant

Number of Participants With Biopsy Proven Rejection

Number of Participants With Graft Loss

Number of Participants With Death

Number of Participants With Known Ganciclovir Resistance (Mutations in Either UL54 or UL97 Genes)

Eligibility

Minimum age: 4 Months. Maximum age: 16 Years. Gender(s): Both.

Criteria:

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

aspartate aminotransferase [AST (SGOT)] or alanine aminotransferase [ALT (SGPT)]

- Patient requires use of any protocol prohibited concomitant medication

- Previous participation in this clinical study

Locations and Contacts

Nantes 44093, France

Paris 75019, France

Paris 75743, France

Hamburg 20246, Germany

Hannover 30625, Germany

Heidelberg 69120, Germany

Koeln 50924, Germany

Aguascalientes 20230, Mexico

Cuernavaca 62428, Mexico

Mexico 06720, Mexico

Barcelona 08035, Spain

Madrid 28046, Spain

Sevilla 41013, Spain

Göteborg 41345, Sweden

Birmingham B4 6NH, United Kingdom

Bristol BS2 8BJ, United Kingdom

Glasgow G3 8SJ, United Kingdom

Gainesville, Florida, United States

Los angeles, Louisiana 90095-1752, United States

Westmead, New South Wales 2145, Australia

New York, New York 10029-6574, United States

South Brisbane, Herston, Queensland 4029, Australia

Sao Paulo, SP 04038-002, Brazil

Salt Lake city, Utah 84108, United States

Parkville, Victoria 3052, Australia

Additional Information

Starting date: July 2011
Last updated: March 27, 2014

Page last updated: August 23, 2015

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