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| ID | Type | Description | Link |
|---|---|---|---|
| ITR-KOR-5085 | |||
| ITRFUN4049 |
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The purpose of this observational study is to investigate whether a sufficient concentration of itraconazole can influence disappearance of a fever (defeverscence) when intravenous (into the vein) itraconazole is administered for resolving unknown neutropenic fever of participants who are given itraconazole oral solution as a prophylaxis under general treatment conditions.
This is a prospective (study following patients forward in time), open-label (all people know the identity of the intervention), multi-center (conducted in more than one center) observational study to examine the correlation between a sufficient blood concentration of itraconazole and disappearance of a fever (defeverscence) when itraconazole injection is administered for resolving unknown neutropenic fever of participants who are given itraconazole oral solution as a prophylaxis under general treatment conditions. The recommended dose of the drug will be 200 milligram (mg), which will be administered intravenously, twice daily for 2 days (a total of 4 doses) and then 200 mg once daily for 12 days. After the administration for a total of 14 days, itraconazole oral solution 200 mg (which is equivalent to 20 ml) twice daily will be continued for a total of 14 days until clinically significant neutropenia is resolved.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Itraconazole | Participants who have been receiving itraconazole will be observed prospectively. Itraconazole will be administered as an infusion (a fluid or a medicine delivered into a vein by way of a needle) over one hour at the dose of 200 milligram (mg) per dose twice daily for 2 days, followed by 200 mg once daily for 12 days, followed by itraconazole oral solution at the dose of 200 mg per dose twice daily for 14 days until clinically significant neutropenia is recovered. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Itraconazole | Drug | Itraconazole will be administered as an infusion (a fluid or a medicine delivered into a vein by way of a needle) over one hour at the dose of 200 milligram (mg) per dose twice daily for 2 days, followed by 200 mg once daily for 12 days, followed by itraconazole oral solution at the dose of 200 mg per dose twice daily for 14 days until clinically significant neutropenia is recovered. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Plasma Level of Itraconazole at 1000 Nanogram Per Milliliter (ng/mL) or Higher After Administration of Study Treatment | 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). | Day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Deferevescence After Administration of Study Treatment | 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. | Day 0 up to Day 14 |
| Mean Time to Defervescence in Participants Who Received the Study Treatment |
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Inclusion Criteria:
Exclusion Criteria:
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Immunocompromized participants with neutropenic fever who have been treated with itraconazole oral solution as prophylaxis and eligible for intravenous (into the vein) itraconazole in accordance with the local label.
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Korea, Ltd., Korea Clinical Trial | Janssen Korea, Ltd., Korea | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | Itraconazole | Participants who had been receiving itraconazole were observed prospectively. Itraconazole was administered as an infusion (a fluid or a medicine delivered into a vein by way of a needle) over one hour at the dose of 200 milligram (mg) per dose twice daily for 2 days, followed by 200 mg once daily for 12 days, and then itraconazole oral solution at the dose of 200 mg per dose twice daily for 14 days until clinically significant neutropenia was recovered. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline characteristics were reported only for intent-to-treat (ITT) population which included 150 participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Itraconazole | Participants who had been receiving itraconazole were observed prospectively. Itraconazole was administered as an infusion (a fluid or a medicine delivered into a vein by way of a needle) over one hour at the dose of 200 milligram (mg) per dose twice daily for 2 days, followed by 200 mg once daily for 12 days, and then itraconazole oral solution at the dose of 200 mg per dose twice daily for 14 days until clinically significant neutropenia was recovered. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 | Percentage of Participants Achieving Plasma Level of Itraconazole at 1000 Nanogram Per Milliliter (ng/mL) or Higher After Administration of Study Treatment | 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). | 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. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Day 5 |
|
Day 1 up to Day 14
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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 | Itraconazole | Participants who had been receiving itraconazole were observed prospectively. Itraconazole was administered as an infusion (a fluid or a medicine delivered into a vein by way of a needle) over one hour at the dose of 200 milligram (mg) per dose twice daily for 2 days, followed by 200 mg once daily for 12 days, and then itraconazole oral solution at the dose of 200 mg per dose twice daily for 14 days until clinically significant neutropenia was recovered. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bacterial sepsis | Infections and infestations | MedDRA | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Associate | Clinical Research Team, Medical Affairs, Medical Dept. Janssen Korea | +82-2-2094-4879 |
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| D009503 | Neutropenia |
| D005334 | Fever |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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Blood cultures
|
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. |
| Day 0 up to Day 14 |
| Duration of Neutropenia | 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. | Day 0 up to Day 14 |
| Absolute Neutrophil Count (ANC) | The mean values for ANC based on blood tests performed on Day 0 (before starting the study treatment) constitute a Baseline measure for ANC. | Baseline (Day 0) |
| Percentage of Participants With Defervescence by Plasma Level of Itraconazole | 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. | Day 5 |
| Plasma Concentration of Itraconazole by Overall Success Rate (OSR) in Participants Who Received the Study Treatment | 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. | Day 5 |
| Percentage of Participants With Baseline Fungal Infection | 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. | Baseline (Day 0) |
| Plasma Concentration of Itraconazole by Breakthrough Fungal Infection | 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. | Day 5 |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Percentage of Participants With Deferevescence After Administration of Study Treatment | 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. | 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. | Posted | Number | Percentage of Participants | Day 0 up to Day 14 |
|
|
|
| Secondary | Mean Time to Defervescence in Participants Who Received the Study Treatment | 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. | 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. | Posted | Mean | Standard Deviation | Days | Day 0 up to Day 14 |
|
|
|
| Secondary | Duration of Neutropenia | 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. | 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. | Posted | Mean | Standard Deviation | Days | Day 0 up to Day 14 |
|
|
|
| Secondary | Absolute Neutrophil Count (ANC) | The mean values for ANC based on blood tests performed on Day 0 (before starting the study treatment) constitute a Baseline measure for ANC. | 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. | Posted | Mean | Standard Deviation | Cells/mm^3 | Baseline (Day 0) |
|
|
|
| Secondary | Percentage of Participants With Defervescence by Plasma Level of Itraconazole | 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. | 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. | Posted | Number | Percentage of Participants | Day 5 |
|
|
|
| Secondary | Plasma Concentration of Itraconazole by Overall Success Rate (OSR) in Participants Who Received the Study Treatment | 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. | 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. | Posted | Mean | Standard Deviation | ng/mL | Day 5 |
|
|
|
| Secondary | Percentage of Participants With Baseline Fungal Infection | 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. | 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. | Posted | Number | Percentage of Participants | Baseline (Day 0) |
|
|
|
| Secondary | Plasma Concentration of Itraconazole by Breakthrough Fungal Infection | 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. | 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. | Posted | Mean | Standard Deviation | ng/mL | Day 5 |
|
|
|
| 28 |
| 203 |
| 49 |
| 203 |
| Cardiac arrest | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Disease progression | General disorders | MedDRA | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Embolism | Vascular disorders | MedDRA | Non-systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Hematemesis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Lung abscess | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Multi-organ failure | General disorders | MedDRA | Non-systematic Assessment |
|
| Neutropenic sepsis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Pneumonia aspiration | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
|
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Anal ulcer | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Hemorroids | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Lip disorder | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA | Non-systematic Assessment |
|
| Hepatic enzymes increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA | Non-systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Bronchopneumonia | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| H1N1 influenza | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Lung abscess | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Streptococcal infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA | Non-systematic Assessment |
|
| Oedema | General disorders | MedDRA | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Depressed level of consciousness | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Hyperbilirubinemia | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
|
| Disorientation | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Anuria | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA | Non-systematic Assessment |
|
PI cannot provide any trial related information to external parties without mutual agreement with the Sponsor. This is valid even after the contract is cancelled.
| D000380 |
| Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D007960 | Leukocyte Disorders |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010879 |
| Piperazines |