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This was a Phase III, randomized, double-blind, placebo-controlled study that was conducted at 24 centers in the United States and Canada. 100 adult and pediatric patients with dysfunctional central venous catheters (CVCs) were randomly assigned in a 1:1 ratio to receive an initial dose of either placebo (Arm A) or tenecteplase (Arm B).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo + Tenecteplase + Tenecteplase (PTT) | Placebo Comparator |
| |
| Tenecteplase + Tenecteplase + Placebo (TTP) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Drug | 2 mL of placebo instilled into lumen of dysfunctional CVC. Patients weighing ≥ 30 kg received 2-mL instillations of study drug (i.e., 2 mg of placebo). Patients weighing < 30 kg received instillations of study drug equal to 110% of the internal lumen volume of the dysfunctional CVC. This dose was rounded to the nearest 0.1 mL and should not have exceeded 2 mL (2 mg). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Who Had Restoration of Central Venous Catheter (CVC) Function Following a Single Administration of Study Drug | Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. | 120 minutes after first dose |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Who Had Restoration of CVC Function Following a Single Administration of Study Drug | Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. | 15 minutes after first dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Levine, M.D. | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21111365 | Derived | Gabrail N, Sandler E, Charu V, Anas N, Lim E, Blaney M, Ashby M, Gillespie BS, Begelman SM. TROPICS 1: a phase III, randomized, double-blind, placebo-controlled study of tenecteplase for restoration of function in dysfunctional central venous catheters. J Vasc Interv Radiol. 2010 Dec;21(12):1852-8. doi: 10.1016/j.jvir.2010.09.002. |
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Three patients were randomized but not treated, therefore the modified intent to treat (MITT) analysis population was 97.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo + Tenecteplase + Tenecteplase (PTT) | Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC). If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC. If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC. Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. |
| FG001 | Tenecteplase + Tenecteplase + Placebo (TTP) | Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC. If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC. If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC. Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo + Tenecteplase + Tenecteplase (PTT) | Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC). If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC. If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC. Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 Patients Who Had Restoration of Central Venous Catheter (CVC) Function Following a Single Administration of Study Drug | Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. | Modified intent to treat (MITT) population | Posted | Number | percentage of participants | 120 minutes after first dose |
|
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Modified intent to treat (MITT) population.
Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.
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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 | Placebo + Tenecteplase + Tenecteplase (PTT) | Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC). If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC. If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC. Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancytopenia | Blood and lymphatic system disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Genentech, Inc. | 800-821-8590 |
| ID | Term |
|---|---|
| D000077785 | Tenecteplase |
| ID | Term |
|---|---|
| D010959 | Tissue Plasminogen Activator |
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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|
| tenecteplase | Drug | 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC. Patients weighing ≥ 30 kg received 2-mL instillations of study drug (i.e., 2 mg of tenecteplase). Patients weighing < 30 kg received instillations of study drug equal to 110% of the internal lumen volume of the dysfunctional CVC. This dose was rounded to the nearest 0.1 mL and should not have exceeded 2 mL (2 mg). |
|
| Percentage of Patients Who Had Restoration of CVC Function Following a Single Administration of Study Drug | Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. | 30 minutes after first dose |
| Percentage of Patients Who Had Restoration of CVC Function Following a Second Administration of Study Drug | Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. | 15 minutes after second dose |
| Percentage of Patients Who Had Restoration of CVC Function Following a Second Administration of Study Drug | Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. | 30 minutes after second dose |
| Percentage of Patients Who Had Restoration of CVC Function Following a Second Administration of Study Drug | Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. | 120 minutes after second dose |
| Percentage of Patients Who Had Restoration of CVC Function Following a Third Administration of Study Drug | Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. | 15 minutes after third dose |
| Percentage of Patients Who Had Restoration of CVC Function Following a Third Administration of Study Drug | Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. | 30 minutes after third dose |
| Percentage of Patients Who Had Restoration of CVC Function Following a Third Administration of Study Drug | Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. | 120 minutes after third dose |
| Percentage of Patients Who Had Restoration of CVC Function Following Administration of One or Two Doses of Tenecteplase | Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. | Up to 120 minutes post-treatment |
| Percentage of Patients Who Had Restoration of CVC Function at Any Time During the Study and Who Maintained Catheter Patency the Next Time the Catheter Was Assessed, up to 7 Days Following the Last Dose of Tenecteplase | Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. | Up to 7 days post-treatment |
| BG001 | Tenecteplase + Tenecteplase + Placebo (TTP) | Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC. If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC. If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC. Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. |
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Tenecteplase + Tenecteplase + Placebo (TTP) | Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC. If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC. If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC. Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. |
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|
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| Secondary | Percentage of Patients Who Had Restoration of CVC Function Following a Single Administration of Study Drug | Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. | Modified intent to treat (MITT) population | Posted | Number | percentage of participants | 15 minutes after first dose |
|
|
|
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| Secondary | Percentage of Patients Who Had Restoration of CVC Function Following a Single Administration of Study Drug | Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. | Modified intent to treat (MITT) population | Posted | Number | Percentage of patients | 30 minutes after first dose |
|
|
|
|
| Secondary | Percentage of Patients Who Had Restoration of CVC Function Following a Second Administration of Study Drug | Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. | Modified intent to treat (MITT) population | Posted | Number | 95% Confidence Interval | percentage of participants | 15 minutes after second dose |
|
|
|
| Secondary | Percentage of Patients Who Had Restoration of CVC Function Following a Second Administration of Study Drug | Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. | Modified intent to treat (MITT) population | Posted | Number | 95% Confidence Interval | Percentage of patients | 30 minutes after second dose |
|
|
|
| Secondary | Percentage of Patients Who Had Restoration of CVC Function Following a Second Administration of Study Drug | Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. | Modified intent to treat (MITT) population | Posted | Number | 95% Confidence Interval | Percentage of patients | 120 minutes after second dose |
|
|
|
| Secondary | Percentage of Patients Who Had Restoration of CVC Function Following a Third Administration of Study Drug | Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. | Modified intent to treat (MITT) population | Posted | Number | 95% Confidence Interval | percentage of participants | 15 minutes after third dose |
|
|
|
| Secondary | Percentage of Patients Who Had Restoration of CVC Function Following a Third Administration of Study Drug | Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. | Modified intent to treat (MITT) population | Posted | Number | 95% Confidence Interval | Percentage of patients | 30 minutes after third dose |
|
|
|
| Secondary | Percentage of Patients Who Had Restoration of CVC Function Following a Third Administration of Study Drug | Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. | Modified intent to treat (MITT) population | Posted | Number | 95% Confidence Interval | Percentage of patients | 120 minutes after third dose |
|
|
|
| Secondary | Percentage of Patients Who Had Restoration of CVC Function Following Administration of One or Two Doses of Tenecteplase | Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. | Modified intent to treat (MITT) population | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 120 minutes post-treatment |
|
|
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| Secondary | Percentage of Patients Who Had Restoration of CVC Function at Any Time During the Study and Who Maintained Catheter Patency the Next Time the Catheter Was Assessed, up to 7 Days Following the Last Dose of Tenecteplase | Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. | Number of patients (from MITT population) with restored CVC function during the treatment period | Posted | Number | 95% Confidence Interval | Percentage of patients | Up to 7 days post-treatment |
|
|
|
| 1 |
| 47 |
| 6 |
| 47 |
| EG001 | Tenecteplase + Tenecteplase + Placebo (TTP) | Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC. If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC. If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC. Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. | 2 | 50 | 14 | 50 |
| Mental Status Changes | Psychiatric disorders |
|
| Venous Thrombosis | Vascular disorders |
|
| Neutropenia | Blood and lymphatic system disorders |
|
| Thrombocytopenia | Blood and lymphatic system disorders |
|
| Tachycardia | Cardiac disorders |
|
| Diarrhoea | Gastrointestinal disorders |
|
| Vomiting | Gastrointestinal disorders |
|
| Abdonimal Pain | Gastrointestinal disorders |
|
| Abdominal Pain Upper | Gastrointestinal disorders |
|
| Epigastric Discomfort | Gastrointestinal disorders |
|
| Nausea | Gastrointestinal disorders |
|
| Stomatitis | Gastrointestinal disorders |
|
| Catheter Site Pain | General disorders |
|
| Asthenia | General disorders |
|
| Axillary Pain | General disorders |
|
| Catheter Site Oedema | General disorders |
|
| Chest Pain | General disorders |
|
| Fatigue | General disorders |
|
| Oedema Peripheral | General disorders |
|
| Pyrexia | General disorders |
|
| Central Line Infection | Infections and infestations |
|
| Escherichia Sepsis | Infections and infestations |
|
| Blood Lactate Dehydrogenase Increased | Investigations |
|
| Platelet Count Decreased | Investigations |
|
| Weight Decreased | Investigations |
|
| Hypertriglycerideaemia | Metabolism and nutrition disorders |
|
| Back Pain | Musculoskeletal and connective tissue disorders |
|
| Bone Pain | Musculoskeletal and connective tissue disorders |
|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders |
|
| Neck Pain | Musculoskeletal and connective tissue disorders |
|
| Pain in Extremity | Musculoskeletal and connective tissue disorders |
|
| Dizziness | Nervous system disorders |
|
| Burning Sensation | Nervous system disorders |
|
| Agitation | Psychiatric disorders |
|
| Anxiety | Psychiatric disorders |
|
| Glycosuria | Renal and urinary disorders |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders |
|
| Bradypnoea | Respiratory, thoracic and mediastinal disorders |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders |
|
| Laryngospasm | Respiratory, thoracic and mediastinal disorders |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders |
|
| Dry Skin | Skin and subcutaneous tissue disorders |
|
| Rash | Skin and subcutaneous tissue disorders |
|
| Hypotension | Vascular disorders |
|
| Haematoma | Vascular disorders |
|
| Syncope | Nervous system disorders |
|
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.
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D010960 | Plasminogen Activators |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |