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Trial record 26 of 102 for:    Valcyte

A Relative Bioavailability Study of Valcyte (Valganciclovir) in Lung Transplant Recipients With or Without Cystic Fibrosis.

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ClinicalTrials.gov Identifier: NCT00377741
Recruitment Status : Completed
First Posted : September 18, 2006
Results First Posted : December 31, 2015
Last Update Posted : December 31, 2015
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Cytomegalovirus Infections
Intervention Drug: valganciclovir [Valcyte]
Enrollment 31
Recruitment Details A total of 31 participants were included from 5 centers in the United States of America. This study was conducted between 01 December 2004 and 30 June 2006.
Pre-assignment Details Participants were received 900 mg of commercial medication of valganciclovir tablet daily for >= 4 days prior to study Day 1 so as to achieve steady-state kinetics of ganciclovir.
Arm/Group Title Cystic Fibrosis (CF) Non-Cystic Fibrosis (Non-CF)
Hide Arm/Group Description Participants with cystic fibrosis (CF) received a single oral dose of valganciclovir 900 mg Participants with non-cystic fibrosis (Non-CF) received a single oral dose of valganciclovir 900 mg
Period Title: Overall Study
Started 16 15
Completed 16 15
Not Completed 0 0
Arm/Group Title Cystic Fibrosis (CF) Non-Cystic Fibrosis (Non-CF) Total
Hide Arm/Group Description Participants with cystic fibrosis (CF) received a single oral dose of valganciclovir 900 mg Participants with non-cystic fibrosis (Non-CF) received a single oral dose of valganciclovir 900 mg Total of all reporting groups
Overall Number of Baseline Participants 16 15 31
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 15 participants 31 participants
29.8  (9.82) 51.6  (8.66) 40.4  (14.34)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 15 participants 31 participants
Female
10
  62.5%
5
  33.3%
15
  48.4%
Male
6
  37.5%
10
  66.7%
16
  51.6%
1.Primary Outcome
Title Area Under The Observed Plasma Concentration-Time Curve Between Dosing Intervals AUC(0-tau)
Hide Description The area under the plasma concentration-time curve from time zero to end of dosing interval (AUC [0-tau]) is a measure of the plasma ganciclovir concentration from time zero to end of dosing interval. It was computed using the linear trapezoidal rule. The pharmacokinetic parameters of valganciclovir were measured in plasma of all participants following a single oral dose valganciclovir at 900 mg on Day 1.
Time Frame Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12 and 24 hours post–dose
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic (PK) analysis population included all participants who received study medication and had at least one PK sample.
Arm/Group Title Cystic Fibrosis (CF) Non-Cystic Fibrosis (Non-CF)
Hide Arm/Group Description:
Participants with cystic fibrosis (CF) received a single oral dose of valganciclovir 900 mg
Participants with non-cystic fibrosis (Non-CF) received a single oral dose of valganciclovir 900 mg
Overall Number of Participants Analyzed 16 15
Mean (Standard Deviation)
Unit of Measure: h*mcg/mL
66.2  (31.3) 54.1  (16.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cystic Fibrosis (CF), Non-Cystic Fibrosis (Non-CF)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean exposure ratio for AUC(0-tau)
Estimated Value 1.24
Confidence Interval (2-Sided) 90%
0.98 to 1.55
Estimation Comments [Not Specified]
2.Primary Outcome
Title Maximum Observed Plasma Concentration (Cmax) of Ganciclovir
Hide Description The Cmax is defined as maximum observed Ganciclovir concentration. Cmax of valganciclovir were measured in plasma of all participants following a single tablet dose Valganciclovir at 900 mg at start of treatment on Day 1.
Time Frame Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12 and 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic (PK) analysis population included all participants who received study medication and had at least one PK sample.
Arm/Group Title Cystic Fibrosis (CF) Non-Cystic Fibrosis (Non-CF)
Hide Arm/Group Description:
Participants with cystic fibrosis (CF) received a single oral dose of valganciclovir 900 mg
Participants with non-cystic fibrosis (Non-CF) received a single oral dose of valganciclovir 900 mg
Overall Number of Participants Analyzed 16 15
Mean (Standard Deviation)
Unit of Measure: μg/mL
8.46  (3.16) 7.54  (2.23)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cystic Fibrosis (CF), Non-Cystic Fibrosis (Non-CF)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean exposure ratio for Cmax
Estimated Value 1.12
Confidence Interval (2-Sided) 90%
0.88 to 1.42
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Time to Maximum Observed Plasma Concentration (Tmax) of Ganciclovir
Hide Description The Tmax is defined as time to reach maximum observed Ganciclovir concentration. The pharmacokinetic parameters of Valganciclovir were measured in plasma of all participants following a single tablet dose Valganciclovir at 900 mg at start of treatment on Day 1.
Time Frame Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12 and 24 hours post–dose
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic (PK) analysis population included all participants who received study medication and had at least one PK sample.
Arm/Group Title Cystic Fibrosis (CF) Non-Cystic Fibrosis (Non-CF)
Hide Arm/Group Description:
Participants with cystic fibrosis (CF) received a single oral dose of valganciclovir 900 mg
Participants with non-cystic fibrosis (Non-CF) received a single oral dose of valganciclovir 900 mg
Overall Number of Participants Analyzed 16 15
Median (Full Range)
Unit of Measure: h
1.99
(1.00 to 4.07)
1.98
(0.92 to 5.97)
4.Secondary Outcome
Title Apparent Elimination Rate (Kelim) of Ganciclovir
Hide Description The apparent elimination rate is equal to the magnitude of the slope from the log-linear regression of plasma concentration versus time over the interval t to 24, where t is the first time-point used for this regression. Kelim was not reported for those participants for whom R-squared (adjusted) was lower than 0.70.
Time Frame Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12 and 24 hours post–dose
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic (PK) analysis population included all participants who received study medication and had at least one PK sample.
Arm/Group Title Cystic Fibrosis (CF) Non-Cystic Fibrosis (Non-CF)
Hide Arm/Group Description:
Participants with cystic fibrosis (CF) received a single oral dose of valganciclovir 900 mg
Participants with non-cystic fibrosis (Non-CF) received a single oral dose of valganciclovir 900 mg
Overall Number of Participants Analyzed 16 15
Mean (Standard Deviation)
Unit of Measure: 1/h
4.43  (0.745) 4.91  (0.684)
5.Secondary Outcome
Title Plasma Half-Life (T1/2) of Ganciclovir
Hide Description Plasma half-life is the time measured for the plasma concentration to decrease by one half. The pharmacokinetic parameters of Valganciclovir were measured in plasma of all participants following a single tablet dose Valganciclovir at 900 mg at start of treatment on Day 1. T1/2 was not reported for those participants for whom R-squared (adjusted) was lower than 0.70.
Time Frame Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12 and 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic (PK) analysis population included all participants who received study medication and had at least one PK sample.
Arm/Group Title Cystic Fibrosis (CF) Non-Cystic Fibrosis (Non-CF)
Hide Arm/Group Description:
Participants with cystic fibrosis (CF) received a single oral dose of valganciclovir 900 mg
Participants with non-cystic fibrosis (Non-CF) received a single oral dose of valganciclovir 900 mg
Overall Number of Participants Analyzed 16 15
Mean (Standard Deviation)
Unit of Measure: h
4.43  (0.75) 4.91  (0.68)
Time Frame Up to 4 Weeks
Adverse Event Reporting Description Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all patients who were enrolled on the study and had at least one safety assessment, whether withdrawn prematurely or no were included in the safety analysis.
 
Arm/Group Title Cystic Fibrosis (CF) Non-Cystic Fibrosis (Non-CF)
Hide Arm/Group Description Participants with cystic fibrosis (CF) received a single oral dose of valganciclovir 900 mg Participants with non-cystic fibrosis (Non-CF) received a single oral dose of valganciclovir 900 mg
All-Cause Mortality
Cystic Fibrosis (CF) Non-Cystic Fibrosis (Non-CF)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cystic Fibrosis (CF) Non-Cystic Fibrosis (Non-CF)
Affected / at Risk (%) Affected / at Risk (%)
Total   3/16 (18.75%)   1/16 (6.25%) 
Gastrointestinal disorders     
Nausea   2/16 (12.50%)  0/16 (0.00%) 
Vomiting   2/16 (12.50%)  0/16 (0.00%) 
General disorders     
Chills   1/16 (6.25%)  0/16 (0.00%) 
Infections and infestations     
Enterococcal Bacteraemia   0/16 (0.00%)  1/16 (6.25%) 
Respiratory, thoracic and mediastinal disorders     
Pneumothorax   1/16 (6.25%)  0/16 (0.00%) 
Skin and subcutaneous tissue disorders     
Hyperhidrosis   1/16 (6.25%)  0/16 (0.00%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cystic Fibrosis (CF) Non-Cystic Fibrosis (Non-CF)
Affected / at Risk (%) Affected / at Risk (%)
Total   5/16 (31.25%)   4/15 (26.67%) 
Gastrointestinal disorders     
Nausea   0/16 (0.00%)  2/15 (13.33%) 
Vomiting   0/16 (0.00%)  1/15 (6.67%) 
Constipation   0/16 (0.00%)  1/15 (6.67%) 
General disorders     
Fatigue   0/16 (0.00%)  1/15 (6.67%) 
Immune system disorders     
Transplant Rejection   1/16 (6.25%)  0/15 (0.00%) 
Infections and infestations     
Clostridium difficile colitis   0/16 (0.00%)  1/15 (6.67%) 
Nasopharyngitis   1/16 (6.25%)  0/15 (0.00%) 
Investigations     
Pulmonary Function Test Decreased   1/16 (6.25%)  0/15 (0.00%) 
Psychiatric disorders     
Insomnia   0/16 (0.00%)  1/15 (6.67%) 
Respiratory, thoracic and mediastinal disorders     
Hypoventilation   0/16 (0.00%)  1/15 (6.67%) 
Idiopathic pneumonia syndrome   0/16 (0.00%)  1/15 (6.67%) 
Increased bronchial secretion   1/16 (6.25%)  0/15 (0.00%) 
Lung disorder   0/16 (0.00%)  1/15 (6.67%) 
Nasal congestion   0/16 (0.00%)  1/15 (6.67%) 
Nasal dryness   1/16 (6.25%)  0/15 (0.00%) 
Rhonchi   1/16 (6.25%)  0/15 (0.00%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Name/Title: Roche Trial Information Hotline
Organization: F. Hoffmann-La Roche AG
Phone: +41 616878333
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00377741     History of Changes
Other Study ID Numbers: WP18046
First Submitted: September 15, 2006
First Posted: September 18, 2006
Results First Submitted: November 26, 2015
Results First Posted: December 31, 2015
Last Update Posted: December 31, 2015