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

NCT00090766 | Completed Phase 2 Results

• 1 other identifier: WV16726
• Study Type: interventional
• Target: 63
• Locations: 7 countries
• Sites: 17

Brief Summary

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.

Conditions

Cytomegalovirus Infections

Outcome Measures

Primary Outcomes (7)

• Mean Area Under the Concentration-Time Curve From 0 to 24 Hours of Valganciclovir

  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.

  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

• Number of Participants With Adverse Events Leading to Dose Interruption or Modification

  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.

  Up to Week 26

• Number of Participants With Opportunistic Infections

  Opportunistic infections included oral candidiasis, candidiasis, herpes simplex, cytomegalovirus antigen positive, cytomegalovirus test positive. The number of participants with opportunistic infections are reported.

  Up to Week 26

• Number of Participants With Any Adverse Events and Any Serious Adverse Events

  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.

  Up to Week 26

• Number of Participants With Adverse Events Leading to Discontinuation of the Study Drug

  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.

  Up to Week 26

• Number of Participants With 3 Grade Shift From Baseline of Adverse Events in Hematology and Serum Chemistry

  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.

  Up to Week 26

• Number of Participants With 4 Grade Shift From Baseline of Adverse Events in Hematology and Serum Chemistry

  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.

  Up to Week 26

Secondary Outcomes (6)

• Number of Participants With Cytomegalovirus Disease Over Time

  Up to Week 26

• Number of Participants With Treatment Failures

  Up to Week 26

• Number of Participants Who Experienced Graft Loss

  Up to Week 26

• Mean Maximum Plasma Concentration of Valganciclovir Over Time

  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

• Mean Elimination Half-Life of Valganciclovir Over Time

  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

Study Arms (3)

Valganciclovir Age Group <= 2 Years

EXPERIMENTAL

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]

Valganciclovir Age Group >2 to <12 Years

EXPERIMENTAL

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]

Valganciclovir Age Group >= 12 Years

EXPERIMENTAL

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]

Interventions

valganciclovir [Valcyte] DRUG

po daily (dose based on body surface area and CrCL)

Valganciclovir Age Group <= 2 Years; Valganciclovir Age Group >2 to <12 Years; Valganciclovir Age Group >= 12 Years

Eligibility Criteria

• Age: 3 Months - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (17)

Unknown Facility

Los Angeles, California, 90095-1752, United States

Location

Unknown Facility

Indianapolis, Indiana, 46202-5124, United States

Location

Unknown Facility

Ann Arbor, Michigan, 48109-0297, United States

Location

Unknown Facility

St Louis, Missouri, 63110, United States

Location

Unknown Facility

New York, New York, 10029, United States

Location

Unknown Facility

Salt Lake City, Utah, 84132-2806, United States

Location

Unknown Facility

Parkville, 3050, Australia

Location

Unknown Facility

Edmonton, Alberta, T6G 2R7, Canada

Location

Unknown Facility

Winnipeg, Manitoba, R3A 1S1, Canada

Location

Unknown Facility

Paris, 75019, France

Location

Unknown Facility

Paris, 75743, France

Location

Unknown Facility

Berlin, 13353, Germany

Location

Unknown Facility

Guadalajara, 44340, Mexico

Location

Unknown Facility

Mexico City, 06720, Mexico

Location

Unknown Facility

Madrid, 28041, Spain

Location

Unknown Facility

Madrid, 28046, Spain

Location

Unknown Facility

Valencia, 46009, Spain

Location

MeSH Terms

Conditions

Cytomegalovirus Infections

Interventions

Valganciclovir

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Ganciclovir; Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Roche Trial Information Hotline
• Organization: F. Hoffmann-La Roche AG

global.trial_information@roche.com

+41 61 6878333

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2004
• First Posted: September 6, 2004
• Study Start: May 1, 2004
• Primary Completion: May 1, 2005
• Study Completion: May 1, 2005
• Last Updated: October 31, 2016
• Results First Posted: October 31, 2016

Record last verified: 2016-03

Locations

US (6); ME (2); DE (1); FR (2); CA (2); ES (3); AU (1)