Trial · NCT01021683
The Relationship of Defeverscence and Itraconazole Plasma Level Study in Immunocompromised Participants
NCT01021683, Completed, Janssen Korea, Ltd., Korea; results first posted 2013-07-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. The Relationship of Defeverscence and Itraconazole Plasma Level Study in Immunocompromised Participants. Trials, record NCT01021683. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01021683
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Relationship of Defeverscence and Itraconazole Plasma Level Study in Immunocompromised Participants
- NCT number
- NCT01021683
- Status
- Completed
- Enrollment
- 203 participants, actual
- Lead sponsor
- Janssen Korea, Ltd., Korea
- Conditions
- Hematologic Neoplasms, Neutropenia, Fever
- Interventions
- Itraconazole
- First posted
- 2009-11-30
- Last updated
- 2013-08-12
- Results first posted
- 2013-07-03
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Achieving Plasma Level of Itraconazole at 1000 Nanogram Per Milliliter (ng/mL) or Higher After Administration of Study Treatment | Day 5 | Percentage of participants who achieved more than or equal to 1000 ng/ml level after administration of study treatment were reported. Plasma level of itraconazole was defined as the sum of itraconazole concentration (IC) and hydroxyitraconazole concentration (HIC). |
| Secondary | Percentage of Participants With Deferevescence After Administration of Study Treatment | Day 0 up to Day 14 | Defervescence was defined as fall of the body temperature below 38.0 degree Celsius (C) at least once after starting to receive the study treatment. |
| Secondary | Mean Time to Defervescence in Participants Who Received the Study Treatment | Day 0 up to Day 14 | The mean time to defervescence was reported in participants who received the study treatment. Defervescence was defined as fall of the body temperature below 38.0 degree C at least once after starting to receive the study treatment. |
| Secondary | Duration of Neutropenia | Day 0 up to Day 14 | The duration of neutropenia was reported. Neutropenia was defined as neutrophil count less than or equal to (\<=) 500 cells per cubic millimeter (cells/mm\^3), or neutrophil count \<=1000 cells/mm\^3 and anticipated to decrease to \<=500 cells/mm\^3 within several days. |
| Secondary | Absolute Neutrophil Count (ANC) | Baseline (Day 0) | The mean values for ANC based on blood tests performed on Day 0 (before starting the study treatment) constitute a Baseline measure for ANC. |
| Secondary | Percentage of Participants With Defervescence by Plasma Level of Itraconazole | Day 5 | Defervescence was defined as fall of the body temperature below 38.0 degree C at least once after starting to receive the study treatment. Plasma level of itraconazole was defined as the sum of IC and HIC. |
| Secondary | Plasma Concentration of Itraconazole by Overall Success Rate (OSR) in Participants Who Received the Study Treatment | Day 5 | Plasma level of itraconazole was defined as the sum of IC and HIC. The OSR was defined based on satisfaction of the following criteria: (1) participants if treated for baseline fungal infection, there was either eradication (removal of fungus in culture), or presumed eradication; no evidence in culture but appeared to be treated clinically, (2) absence of breakthrough fungal infection during the treatment and for 7 days after completing the treatment, (3) survival for 7 days after completing the treatment, (4) absence of early withdrawal due to adverse events or lack of efficacy, and (5) defervescence. The presence and absence of OS was reported. |
| Secondary | Percentage of Participants With Baseline Fungal Infection | Baseline (Day 0) | Blood cultures (a laboratory test on a sample of blood) were assessed to identify fungus. Percentage of participants with presence or absence of fungus before starting the study drug were calculated. |
| Secondary | Plasma Concentration of Itraconazole by Breakthrough Fungal Infection | Day 5 | Plasma level of itraconazole was defined as the sum of IC and HIC. A breakthrough fungal infection was defined as any fungal infection that was diagnosed more than (\>) 3 days on or during therapy or within 7 days after completion of therapy. Blood cultures were assessed to identify fungus. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Achieving Plasma Level of Itraconazole at 1000 Nanogram Per Milliliter (ng/mL) or Higher After Administration of Study Treatment | Day 5 | The intent-to-treat (ITT) population included the participants who satisfied the eligibility criteria, received the study drug at least once, and in whom the primary efficacy endpoint was measured at least once. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Deferevescence After Administration of Study Treatment | Day 0 up to Day 14 | The ITT population included the participants who satisfied the eligibility criteria, received the study drug at least once, and in whom the primary efficacy endpoint was measured at least once. | Percentage of Participants | NUMBER |
| SECONDARY | Mean Time to Defervescence in Participants Who Received the Study Treatment | Day 0 up to Day 14 | The ITT population included the participants who satisfied the eligibility criteria, received the study drug at least once, and in whom the primary efficacy endpoint was measured at least once. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this measure. | Days | MEAN |
| SECONDARY | Duration of Neutropenia | Day 0 up to Day 14 | The ITT population included the participants who satisfied the eligibility criteria, received the study drug at least once, and in whom the primary efficacy endpoint was measured at least once. | Days | MEAN |
| SECONDARY | Absolute Neutrophil Count (ANC) | Baseline (Day 0) | The ITT population included the participants who satisfied the eligibility criteria, received the study drug at least once, and in whom the primary efficacy endpoint was measured at least once. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this measure. | Cells/mm^3 | MEAN |
| SECONDARY | Percentage of Participants With Defervescence by Plasma Level of Itraconazole | Day 5 | The ITT population included the participants who satisfied the eligibility criteria, received the study drug at least once, and in whom the primary efficacy endpoint was measured at least once. Here, 'n' signifies participants who were evaluable for this measure at given time points. | Percentage of Participants | NUMBER |
| SECONDARY | Plasma Concentration of Itraconazole by Overall Success Rate (OSR) in Participants Who Received the Study Treatment | Day 5 | The ITT population included the participants who satisfied the eligibility criteria, received the study drug at least once, and in whom the primary efficacy endpoint was measured at least once. Here, 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for given category. | ng/mL | MEAN |
| SECONDARY | Percentage of Participants With Baseline Fungal Infection | Baseline (Day 0) | The ITT population included the participants who satisfied the eligibility criteria, received the study drug at least once, and in whom the primary efficacy endpoint was measured at least once. | Percentage of Participants | NUMBER |
| SECONDARY | Plasma Concentration of Itraconazole by Breakthrough Fungal Infection | Day 5 | The ITT population included the participants who satisfied the eligibility criteria, received the study drug at least once, and in whom the primary efficacy endpoint was measured at least once. Here, 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for given category. | ng/mL | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Achieving Plasma Level of Itraconazole at 1000 Nanogram Per Milliliter (ng/mL) or Higher After Administration of Study Treatment | Itraconazole | 68.0 | 95% Confidence Interval 60.53 to 75.5 | Percentage of Participants | |
| Percentage of Participants With Deferevescence After Administration of Study Treatment | Itraconazole | 87.3 | Percentage of Participants | ||
| Mean Time to Defervescence in Participants Who Received the Study Treatment | Itraconazole | 3.14 | Standard Deviation 1.57 | Days | |
| Duration of Neutropenia | Itraconazole | 2.64 | Standard Deviation 1.96 | Days | |
| Absolute Neutrophil Count (ANC) | Itraconazole | 56.26 | Standard Deviation 127.91 | Cells/mm^3 | |
| Percentage of Participants With Defervescence by Plasma Level of Itraconazole | Itraconazole | IC+HIC < 1000ng/mL (n=48) | 70.8 | Percentage of Participants | |
| Percentage of Participants With Defervescence by Plasma Level of Itraconazole | Itraconazole | IC+HIC >= 1000ng/mL (n=102) | 95.1 | Percentage of Participants | |
| Plasma Concentration of Itraconazole by Overall Success Rate (OSR) in Participants Who Received the Study Treatment | Itraconazole | Presence of OS (n=95) | 2328.10 | Standard Deviation 1612.00 | ng/mL |
| Plasma Concentration of Itraconazole by Overall Success Rate (OSR) in Participants Who Received the Study Treatment | Itraconazole | Absence of OS (n=39) | 1690.90 | Standard Deviation 1185.20 | ng/mL |
| Percentage of Participants With Baseline Fungal Infection | Itraconazole | 5.3 | 1185.20 | Percentage of Participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Itraconazole | 203 | |
| Overall Study | COMPLETED | Itraconazole | 132 | |
| Overall Study | NOT COMPLETED | Itraconazole | 71 |
Source ClinicalTrials.gov
Adverse events79
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Itraconazole | 8 | 203 | |
| other | Abdominal distension | Gastrointestinal disorders | Itraconazole | 3 | 203 | |
| other | Nausea | Gastrointestinal disorders | Itraconazole | 2 | 203 | |
| other | Abdominal pain | Gastrointestinal disorders | Itraconazole | 1 | 203 | |
| other | Anal ulcer | Gastrointestinal disorders | Itraconazole | 1 | 203 | |
| other | Constipation | Gastrointestinal disorders | Itraconazole | 1 | 203 | |
| other | Dyspepsia | Gastrointestinal disorders | Itraconazole | 1 | 203 | |
| other | Haematochezia | Gastrointestinal disorders | Itraconazole | 1 | 203 | |
| other | Hemorroids | Gastrointestinal disorders | Itraconazole | 1 | 203 | |
| other | Lip disorder | Gastrointestinal disorders | Itraconazole | 1 | 203 |
1 to 10 of 79Source ClinicalTrials.gov
See all 79 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Itraconazole | ||
| Total, other adverse events | Itraconazole | 49 | 203 |
| Total, serious adverse events | Itraconazole | 28 | 203 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01021683
GET https://conductscience.org/api/trials/v1/NCT01021683/events?page=2