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This study will assess the relative bioavailability of ganciclovir from the pro-drug valganciclovir in lung transplant recipients with or without cystic fibrosis. Each patient will receive 900mg valganciclovir daily for the period specified at their center, starting as soon as possible after the transplant. Pharmacokinetic assessments will be made provided that steady-state kinetics of ganciclovir and immunosuppressive drugs have been obtained (>=4 days of drug therapy). Blood samples for pharmacokinetic analysis will be taken up to 24h post-dose on one occasion. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| valganciclovir [Valcyte] | Drug | 900mg po |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under The Observed Plasma Concentration-Time Curve Between Dosing Intervals AUC(0-tau) | 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. | 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 |
| Maximum Observed Plasma Concentration (Cmax) of Ganciclovir | 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Maximum Observed Plasma Concentration (Tmax) of Ganciclovir | 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. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles | California | 90033 | United States | |||
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cystic Fibrosis (CF) | Participants with cystic fibrosis (CF) received a single oral dose of valganciclovir 900 mg |
| FG001 | Non-Cystic Fibrosis (Non-CF) | Participants with non-cystic fibrosis (Non-CF) received a single oral dose of valganciclovir 900 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Apparent Elimination Rate (Kelim) of Ganciclovir | 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. | 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 |
| Plasma Half-Life (T1/2) of Ganciclovir | 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. | 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 |
| Denver |
| Colorado |
| 80262 |
| United States |
| Durham | North Carolina | 27710 | United States |
| Cleveland | Ohio | 44195 | United States |
| Pittsburgh | Pennsylvania | 15213 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cystic Fibrosis (CF) | Participants with cystic fibrosis (CF) received a single oral dose of valganciclovir 900 mg |
| BG001 | Non-Cystic Fibrosis (Non-CF) | Participants with non-cystic fibrosis (Non-CF) received a single oral dose of valganciclovir 900 mg |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Under The Observed Plasma Concentration-Time Curve Between Dosing Intervals AUC(0-tau) | 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. | The Pharmacokinetic (PK) analysis population included all participants who received study medication and had at least one PK sample. | Posted | Mean | Standard Deviation | h*mcg/mL | 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 |
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| Primary | Maximum Observed Plasma Concentration (Cmax) of Ganciclovir | 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. | The Pharmacokinetic (PK) analysis population included all participants who received study medication and had at least one PK sample. | Posted | Mean | Standard Deviation | μg/mL | 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 |
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| Secondary | Time to Maximum Observed Plasma Concentration (Tmax) of Ganciclovir | 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. | The Pharmacokinetic (PK) analysis population included all participants who received study medication and had at least one PK sample. | Posted | Median | Full Range | h | 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 |
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| Secondary | Apparent Elimination Rate (Kelim) of Ganciclovir | 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. | The Pharmacokinetic (PK) analysis population included all participants who received study medication and had at least one PK sample. | Posted | Mean | Standard Deviation | 1/h | 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 |
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| Secondary | Plasma Half-Life (T1/2) of Ganciclovir | 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. | The Pharmacokinetic (PK) analysis population included all participants who received study medication and had at least one PK sample. | Posted | Mean | Standard Deviation | h | 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 |
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Up to 4 Weeks
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cystic Fibrosis (CF) | Participants with cystic fibrosis (CF) received a single oral dose of valganciclovir 900 mg | 3 | 16 | 5 | 16 | ||
| EG001 | Non-Cystic Fibrosis (Non-CF) | Participants with non-cystic fibrosis (Non-CF) received a single oral dose of valganciclovir 900 mg | 1 | 16 | 4 | 15 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Chills | General disorders | Systematic Assessment |
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| Enterococcal Bacteraemia | Infections and infestations | Systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoventilation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Idiopathic pneumonia syndrome | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Increased bronchial secretion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Lung disorder | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Nasal dryness | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Rhonchi | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Clostridium difficile colitis | Infections and infestations | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Transplant Rejection | Immune system disorders | Systematic Assessment |
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| Pulmonary Function Test Decreased | Investigations | Systematic Assessment |
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| Insomnia | Psychiatric disorders | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roche Trial Information Hotline | F. Hoffmann-La Roche AG | +41 616878333 | global.trial_information@roche.com |
| ID | Term |
|---|---|
| D003586 | Cytomegalovirus Infections |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000077562 | Valganciclovir |
| ID | Term |
|---|---|
| D015774 | Ganciclovir |
| D000212 | Acyclovir |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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