Trial · NCT04683003
A Study of TAK-755 in Participants With Congenital Thrombotic Thrombocytopenic Purpura
NCT04683003, Phase 3, Active not recruiting, Takeda
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of TAK-755 in Participants With Congenital Thrombotic Thrombocytopenic Purpura. Trials, record NCT04683003. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04683003
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of TAK-755 in Participants With Congenital Thrombotic Thrombocytopenic Purpura
- NCT number
- NCT04683003
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 77 participants, estimated
- Lead sponsor
- Takeda
- Conditions
- Thrombotic Thrombocytopenic Purpura (TTP)
- Interventions
- TAK-755
- First posted
- 2020-12-24
- Last updated
- 2026-04-02
- Other registries' IDs
- eudract:2020-003348-10
Source ClinicalTrials.gov
Registered outcomes39
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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/NCT04683003
GET https://conductscience.org/api/trials/v1/NCT04683003/registered?page=2