Trial · NCT04683003
Registered outcomes39
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 39
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Related Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Throughout the study period of approximately 6 years | TEAE: any adverse event emerging or manifesting at or after the initiation of treatment with TAK-755 or any existing adverse event that worsens in either intensity or frequency following exposure to TAK-755. SAE: Signs, symptoms or outcomes which results in death, requires inpatient hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity, results in a congenital abnormality/birth defect, or is an important medical event. |
| Secondary | Number of Acute Thrombotic Thrombocytopenic Purpura (TTP) Events in Participants with Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Undergoing Prophylactic Treatment with TAK-755 | Up to approximately 3 years | The number of acute TTP Events in participants with cTTP receiving prophylactic treatment with TAK-755 (rADAMTS13) will be assessed. |
| Secondary | Incidence Rate of Acute TTP Events in Participants with cTTP Undergoing Prophylactic Treatment with TAK-755 | Up to approximately 3 years | Annualized acute TTP event incidence rate is calculated as the number of acute TTP events while receiving prophylactic treatment with TAK-755 (rADAMTS13) divided by the duration of the observation period in years. Annualized acute TTP event rate while participants are receiving prophylactic treatment with TAK-755 will be assessed. |
| Secondary | Number of Acute TTP Events Resolved After Treatment with TAK-755 while Enrolled in the Study | Throughout the study period of approximately 6 years | Acute TTP events are considered resolved when: Platelet count is \>=150,000/ μL or platelet count is within 25% of baseline and elevation of lactate dehydrogenase (LDH) \<= 1.5 x baseline or \<= 1.5 x upper limit of normal (ULN). |
| Secondary | Proportion of Acute TTP Events Resolved After Treatment with TAK-755 while Enrolled in the Study | Throughout the study period of approximately 6 years | Proportion of acute TTP events that have resolved after treatment with TAK-755 (rADAMTS13) while enrolled in the study will be assessed. Acute TTP events are considered resolved when: Platelet count is \>=150,000/ μL or platelet count is within 25% of baseline and elevation of LDH \<= 1.5 x baseline or \<= 1.5 x ULN. |
| Secondary | Incidence of Acute TTP Events while Participants are on Their Final Dose and Dosing Regimen | Throughout the study period of approximately 6 years | Incidence of annualized acute TTP events while participants are on their final dose and dosing regimen will be assessed. |
| Secondary | Time to Resolution of Acute TTP Events Following Treatment with IP | Throughout the study period of approximately 6 years | Time to resolution of acute TTP event is defined as the time from initial treatment of the event to resolution of the acute TTP event. Acute TTP events are considered resolved when: Platelet count is \>=150,000/ μL or platelet count is within 25% of baseline and elevation of LDH \<= 1.5 x baseline or \<= 1.5 x ULN. |
| Secondary | Total Quantity of TAK-755 Administered During the Treatment of Acute TTP Events | Throughout the study period of approximately 6 years | Total quantity of TAK-755 administered during the treatment of acute TTP events will be assessed. Acute events typically require 3-4 days of intensified treatment. |
| Secondary | Incidence of Supplemental Doses Prompted by Subacute TTP Events | Up to approximately 3 years | Incidence of supplemental doses prompted by subacute TTP events in the prophylactic cohort will be assessed. |
| Secondary | Incidence of Dose Modifications Not Prompted by an Acute TTP Event | Up to approximately 3 years | Incidence of dose modifications not prompted by an acute TTP event in the prophylactic cohort will be assessed. |
| Secondary | Incidence of Thrombocytopenia | Up to approximately 3 years | Thrombocytopenia is defined as a drop in platelet count \>=25 percent (%) of baseline or a platelet count less than (\<) 150,000/mcL. Incidence of thrombocytopenia in the prophylactic cohort will be assessed. |
| Secondary | Incidence of Microangiopathic Hemolytic Anemia | Up to approximately 3 years | Microangiopathic hemolytic anemia is defined as an elevation of LDH greater than (\>) 1.5xbaseline or LDH \> 1.5xULN. Incidence of microangiopathic hemolytic anemia in the prophylactic cohort will be assessed. |
| Secondary | Incidence of Neurological Symptoms | Up to approximately 3 years | Neurological symptoms include headache, confusion, dysphonia, dysarthria, focal or general motor symptoms including seizures. Incidence of neurological symptoms in the prophylactic cohort will be assessed. |
| Secondary | Incidence of Renal Dysfunction | Up to approximately 3 years | Renal dysfunction is defined as an increase in serum creatinine \>1.5xbaseline. Incidence of renal dysfunction in the prophylactic cohort will be assessed. |
| Secondary | incidence of Abdominal Pain | Up to approximately 3 years | Incidence of abdominal pain in the prophylactic cohort will be assessed. |
| Secondary | Incidence of TTP Manifestations for Participants Receiving TAK-755 as a Prophylactic Treatment | Up to approximately 3 years | TTP manifestations are defined as a composite of thrombocytopenia, microangiopathic hemolytic anemia, and TTP-related signs/symptoms including but not limited to (renal signs, neurologic symptoms, fever, fatigue/lethargy and abdominal pain). Incidence of TTP manifestations in the prophylactic cohort will be assessed. |
| Secondary | Incidence of TTP Manifestations While Receiving the Final Prophylactic Treatment Regimen with TAK-755 in the Home Setting | Up to approximately 3 years | TTP manifestations are defined as a composite of thrombocytopenia, microangiopathic hemolytic anemia, and TTP-related signs/symptoms including but not limited to (renal signs, neurologic symptoms, fever, fatigue/lethargy and abdominal pain). Incidence of TTP manifestations in the prophylactic cohort in the home setting will be assessed. |
| Secondary | Incidence of Acute TTP Events in Participants Receiving TAK-755 Prophylactically in the Home Setting | Up to approximately 3 years | Incidence of acute TTP events in participants receiving TAK-755 prophylactically in the home setting will be assessed. |
| Secondary | Incidence of all AEs and SAEs (Including Unrelated) | Throughout the study period of approximately 6 years | AE: any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this IP or medicinal product. SAE: Signs, symptoms or outcomes which results in death, requires inpatient hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity, results in a congenital abnormality/birth defect, or is an important medical event. |
| Secondary | Proportion of Participants with anti-ADAMTS13 Binding Antibodies and Neutralizing Antibodies Following ADAMTS13 Administration | Throughout the study period of approximately 6 years | Proportion of participants with anti-ADAMTS13 binding antibodies and neutralizing antibodies following ADAMTS13 administration will be assessed. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT04683003/registered