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A Study of Valcyte (Valganciclovir) Syrup Formulation in Pediatric Solid Organ Transplant Recipients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00090766
First received: September 3, 2004
Last updated: September 14, 2016
Last verified: March 2016
  Purpose
This study will assess the safety and pharmacokinetics of Valcyte syrup in pediatric solid organ transplant recipients. The anticipated time on study treatment is 3-12 months and the target sample size is less than 100 individuals.

Condition Intervention Phase
Cytomegalovirus Infections
Drug: valganciclovir [Valcyte]
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Pharmacokinetics of Valganciclovir Syrup Formulation in Pediatric Solid Organ Transplant Recipients

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Mean Area Under the Concentration-Time Curve From 0 to 24 Hours of Valganciclovir [ Time Frame: Pre-dose; 1-3, 3-7, 7-12 hours post dose on any day between Day 7 to Day 14; Week 6, Week 10, and Week 14 ] [ Designated as safety issue: No ]
    Area Under the Plasma Concentration-Time Curve (AUC) is a measure of the plasma concentration of the drug over time. The AUC 0-24 hours is area under the plasma concentration-time curve from time zero through 24 hours after dosing. A compartmental model was used to measure the plasma concentrations of valganciclovir. One participant was not analyzed for this outcome measure as the participant underwent both a kidney and liver transplant.

  • Number of Participants With Adverse Events Leading to Dose Interruption or Modification [ Time Frame: Up to Week 26 ] [ Designated as safety issue: No ]
    An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation in participant administered a pharmaceutical product, which did not necessarily have to have a causal relationship with this treatment. The number of participants with AEs leading to dose interruptions or modifications are reported.

  • Number of Participants With Opportunistic Infections [ Time Frame: Up to Week 26 ] [ Designated as safety issue: No ]
    Opportunistic infections included oral candidiasis, candidiasis, herpes simplex, cytomegalovirus antigen positive, cytomegalovirus test positive. The number of participants with opportunistic infections are reported.

  • Number of Participants With Any Adverse Events and Any Serious Adverse Events [ Time Frame: Up to Week 26 ] [ Designated as safety issue: No ]
    An AE was defined as any untoward medical occurrence in a clinical investigation in participant administered a pharmaceutical product, which did not necessarily have to have a causal relationship with this treatment. A serious adverse event (SAE) is any experience or a significant hazard, that is fatal, life-threatening, requires in-patient hospitalization or prolongation of existing one, results in persistent or significant disability, is a congenital anomaly, is medically significant or requires intervention to prevent one or other of the outcomes listed above.

  • Number of Participants With Adverse Events Leading to Discontinuation of the Study Drug [ Time Frame: Up to Week 26 ] [ Designated as safety issue: No ]
    An AE was defined as any untoward medical occurrence in a clinical investigation in participant administered a pharmaceutical product, which did not necessarily have to have a causal relationship with this treatment. The number of participants with AEs leading to discontinuation of the study drug is reported.

  • Number of Participants With 3 Grade Shift From Baseline of Adverse Events in Hematology and Serum Chemistry [ Time Frame: Up to Week 26 ] [ Designated as safety issue: No ]
    The number of participants experiencing a 3 grade shift (example from Grade 0 to Grade 3) from baseline (BL) in hematology and serum chemistry laboratory parameters are reported. The data was analyzed for overall study only.

  • Number of Participants With 4 Grade Shift From Baseline of Adverse Events in Hematology and Serum Chemistry [ Time Frame: Up to Week 26 ] [ Designated as safety issue: No ]
    The number of participants experiencing a 4 grade shift (example from Grade 0 to Grade 4) from BL in hematology and serum chemistry laboratory parameters are reported. The data was analyzed for overall study only.


Secondary Outcome Measures:
  • Number of Participants With Cytomegalovirus Disease Over Time [ Time Frame: Up to Week 26 ] [ Designated as safety issue: No ]
    Cytomegalovirus (CMV) disease is defined as syndrome or tissue invasive disease in which CMV virus was identified in blood, urine, biopsy or other suitable specimen, which could be in conjunction with one or more of the following events: a) CMV syndrome was defined as virus present in blood or other suitable specimen, plus fever, and any of the following: leukopenia, atypical lymphocytosis, thrombopenia or elevated hepatic transaminases (for non-liver recipients). b) The diagnosis of organ specific tissue invasive CMV disease was evidence of CMV in the tissue (CMV inclusion bodies or in situ detection of CMV antigen or DNA), plus signs/symptoms of organ dysfunction.

  • Number of Participants With Treatment Failures [ Time Frame: Up to Week 26 ] [ Designated as safety issue: No ]
    Treatment failure was defined as either the development of CMV (viremia, antigenemia or test positive) requiring treatment up to day 100 post-transplant (i.e, while undergoing prophylaxis with valganciclovir up to day 100) or discontinuation of study medication due to lack of efficacy or to toxicity.

  • Number of Participants Who Experienced Graft Loss [ Time Frame: Up to Week 26 ] [ Designated as safety issue: No ]
    Graft loss was defined as impairment of organ function to such a degree that the participant died or underwent re-transplantation.

  • Mean Maximum Plasma Concentration of Valganciclovir Over Time [ Time Frame: Pre-dose; 1-3, 3-7, 7-12 hours post dose on any day between Day (D) 7 to D 14; and at Week (W) 6, W 10, and W 14 ] [ Designated as safety issue: No ]
    Maximum Plasma Concentration (Cmax) is defined as the maximum observed plasma concentration of Valganciclovir. Participants with kidney, liver and heart transplant were analyzed. One participant was not analyzed for this outcome measure as the participant underwent both a kidney and liver transplant.

  • Mean Elimination Half-Life of Valganciclovir Over Time [ Time Frame: Pre-dose; 1-3, 3-7, 7-12 hours post dose on any day between Day 7 to Day 14; Week 6, Week 10, and Week 14 ] [ Designated as safety issue: No ]
    The Elimination Half-Life Period is defined as the time measured for the plasma concentration to decrease by half to its original concentration. One participant was not analyzed for this outcome measure as the participant underwent both a kidney and liver transplant. Here n represents number of participant with specific transplant i.e., kidney, liver, and heart.

  • Number of Participants Who Experienced Episodes of Rejection Over Time [ Time Frame: Up to Week 26 ] [ Designated as safety issue: No ]
    Participants with biopsy proven active rejection are reported.


Enrollment: 63
Study Start Date: May 2004
Study Completion Date: May 2005
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Valganciclovir Age Group <= 2 Years
Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 milligrams (mg) once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose = 7 * body surface area (BSA) * creatinine clearance (CrCLS).
Drug: valganciclovir [Valcyte]
po daily (dose based on body surface area and CrCL)
Experimental: Valganciclovir Age Group >2 to <12 Years
Eligible participants aged >2 to <12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose = 7 * BSA * CrCLS.
Drug: valganciclovir [Valcyte]
po daily (dose based on body surface area and CrCL)
Experimental: Valganciclovir Age Group >= 12 Years
Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose = 7 * BSA * CrCLS.
Drug: valganciclovir [Valcyte]
po daily (dose based on body surface area and CrCL)

  Eligibility

Ages Eligible for Study:   3 Months to 16 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients between 3 months and 16 years of age;
  • first solid organ transplant (eg, kidney, liver, heart);
  • able to tolerate oral medication;
  • females of childbearing potential must agree to utilize an effective method of contraception throughout the study and for 90 days following discontinuation of study drug;
  • patients at risk of developing CMV disease (all transplant recipients other than those who are D-R- for CMV).

Exclusion Criteria:

  • patients who have previously participated in this study;
  • patients who are participating in another clinical trial (except with the approval of the Sponsor);
  • severe, uncontrolled diarrhea (more than 5 watery stools per day);
  • pregnant or lactating females.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00090766

Locations
United States, California
Los Angeles, California, United States, 90095-1752
United States, Indiana
Indianapolis, Indiana, United States, 46202-5124
United States, Michigan
Ann Arbor, Michigan, United States, 48109-0297
United States, Missouri
St Louis, Missouri, United States, 63110
United States, New York
New York, New York, United States, 10029
United States, Utah
Salt Lake City, Utah, United States, 84132-2806
Australia
Parkville, Australia, 3050
Canada, Alberta
Edmonton, Alberta, Canada, T6G 2R7
Canada, Manitoba
Winnipeg, Manitoba, Canada, R3A 1S1
France
Paris, France, 75019
Paris, France, 75743
Germany
Berlin, Germany, 13353
Mexico
Guadalajara, Mexico, 44340
Mexico City, Mexico, 06720
Spain
Madrid, Spain, 28041
Madrid, Spain, 28046
Valencia, Spain, 46009
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00090766     History of Changes
Other Study ID Numbers: WV16726 
Study First Received: September 3, 2004
Results First Received: June 24, 2016
Last Updated: September 14, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Valganciclovir
Ganciclovir
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on December 09, 2016