Trial · NCT02878603
Follow-up Study for Patients Who Completed Study ALX0681-C301 (Post-HERCULES)
NCT02878603, Phase 3, Completed, Sanofi; results first posted 2021-11-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Follow-up Study for Patients Who Completed Study ALX0681-C301 (Post-HERCULES). Trials, record NCT02878603. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02878603
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Follow-up Study for Patients Who Completed Study ALX0681-C301 (Post-HERCULES)
- NCT number
- NCT02878603
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 104 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Acquired Thrombotic Thrombocytopenic Purpura
- Interventions
- Caplacizumab, Standard of Care
- First posted
- 2016-08-25
- Last updated
- 2022-03-28
- Other registries' IDs
- eudract:2016-001503-23
- Results first posted
- 2021-11-22
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Acquired Thrombotic Thrombocytopenic Purpura (aTTP) Related Events | From Baseline up to 36 months | aTTP-related events were defined as: aTTP-related death, recurrence of aTTP (defined as recurrent thrombocytopenia requiring initiation of daily PE) or at least one major thromboembolic event (e.g., myocardial infarction, cerebrovascular accident, pulmonary embolism, or deep venous thrombosis). Percentage of participants with at least one aTTP-related events during the study were reported in this outcome measure. |
| Primary | Number of Acquired Thrombotic Thrombocytopenic Purpura-related Events | From Baseline up to 36 months | aTTP-related events were defined as: aTTP-related death, recurrence of aTTP (defined as recurrent thrombocytopenia requiring initiation of daily PE) or at least one major thromboembolic event (e.g., myocardial infarction, cerebrovascular accident, pulmonary embolism or deep venous thrombosis). |
| Primary | Time to First Acquired Thrombotic Thrombocytopenic Purpura-related Events | From Baseline up to 36 months | Time to first aTTP-related events was defined as the duration of time (in days) from Baseline up to first aTTP-related event in LTS16371. Participants without an event during LTS16371 were censored at the end of the study. Kaplan-Meier method was used for the analysis. |
| Primary | Number of Participants With aTTP Related Deaths Reported During the Study | From Baseline up to 36 months | |
| Primary | Percentage of Participants With Recurrence of Disease (aTTP) | From Baseline up to 36 months | Recurrence of aTTP was defined as recurrent thrombocytopenia requiring initiation of daily PE. |
| Primary | Number of Disease (aTTP) Recurrence Reported During the Study | From Baseline up to 36 months | Recurrence of aTTP was defined as recurrent thrombocytopenia requiring initiation of daily PE. |
| Primary | Time to Recurrence of Disease (aTTP) | From Baseline up to 36 months | Time to first recurrence of disease (aTTP) was defined as the duration of time (in days) from Baseline up to first recurrence of aTTP event in LTS16371. Recurrence of aTTP: defined as recurrent thrombocytopenia requiring initiation of daily PE. Participants without an event during LTS16371 were censored at the end of the study. Kaplan-Meier method was used for the analysis. |
| Primary | Percentage of Participants With Major Thromboembolic Events Including Thrombotic Thrombocytopenic Purpura (TTP) | From Baseline up to 36 months | Major thromboembolic events (e.g., myocardial infarction, cerebrovascular accident, pulmonary embolism, or deep venous thrombosis) were assessed based on Standardized Medical Dictionary for Regulatory Activities (MedDRA) Query (SMQ). Reported major thromboembolic events included TTP recurrences. |
| Primary | Number of Major Thromboembolic Events Including Thrombotic Thrombocytopenic Purpura | From Baseline up to 36 months | Major thromboembolic events (e.g., myocardial infarction, cerebrovascular accident, pulmonary embolism, or deep venous thrombosis) were assessed based on SMQ. Reported major thromboembolic events included TTP recurrences. |
| Primary | Time to First Major Thromboembolic Event | From Baseline up to 36 months | Time to first major thromboembolic event was defined as the duration of time (in days) from Baseline up to first major thromboembolic event in LTS16371. Participants without an event during LTS16371 were censored at the end of the study. Kaplan-Meier method was used for the analysis. |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Acquired Thrombotic Thrombocytopenic Purpura (aTTP) Related Events | From Baseline up to 36 months | Analysis was performed on efficacy intention-to-observe (efficacy ITO) population which included participants who were enrolled in LTS16371 and did not experience an aTTP recurrence in previous study ALX0681-C301 or prior to the beginning of LTS16371. | percentage of participants | NUMBER |
| PRIMARY | Number of Acquired Thrombotic Thrombocytopenic Purpura-related Events | From Baseline up to 36 months | Analysis was performed on efficacy ITO population which included participants who were enrolled in LTS16371 and did not experience an aTTP recurrence in previous study ALX0681-C301 or prior to the beginning of LTS16371. | aTTP-related events | NUMBER |
| PRIMARY | Time to First Acquired Thrombotic Thrombocytopenic Purpura-related Events | From Baseline up to 36 months | Analysis was performed on efficacy ITO population which included participants who were enrolled in LTS16371 and did not experience an aTTP recurrence in previous study ALX0681-C301 or prior to the beginning of LTS16371. | days | MEDIAN |
| PRIMARY | Number of Participants With aTTP Related Deaths Reported During the Study | From Baseline up to 36 months | Analysis was performed on efficacy ITO population which included participants who were enrolled in LTS16371 and did not experience an aTTP recurrence in previous study ALX0681-C301 or prior to the beginning of LTS16371. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Percentage of Participants With Recurrence of Disease (aTTP) | From Baseline up to 36 months | Analysis was performed on efficacy ITO population which included participants who were enrolled in LTS16371 and did not experience an aTTP recurrence in previous study ALX0681-C301 or prior to the beginning of LTS16371. | percentage of participants | NUMBER |
| PRIMARY | Number of Disease (aTTP) Recurrence Reported During the Study | From Baseline up to 36 months | Analysis was performed on efficacy ITO population which included participants who were enrolled in LTS16371 and did not experience an aTTP recurrence in previous study ALX0681-C301 or prior to the beginning of LTS16371. | aTTP recurrences | NUMBER |
| PRIMARY | Time to Recurrence of Disease (aTTP) | From Baseline up to 36 months | Analysis was performed on efficacy ITO population which included participants who were enrolled in LTS16371 and did not experience an aTTP recurrence in previous study ALX0681-C301 or prior to the beginning of LTS16371. | days | MEDIAN |
| PRIMARY | Percentage of Participants With Major Thromboembolic Events Including Thrombotic Thrombocytopenic Purpura (TTP) | From Baseline up to 36 months | Analysis was performed on efficacy ITO population which included participants who were enrolled in LTS16371 and did not experience an aTTP recurrence in previous study ALX0681-C301 or prior to the beginning of LTS16371. | percentage of participants | NUMBER |
| PRIMARY | Number of Major Thromboembolic Events Including Thrombotic Thrombocytopenic Purpura | From Baseline up to 36 months | Analysis was performed on efficacy ITO population which included participants who were enrolled in LTS16371 and did not experience an aTTP recurrence in previous study ALX0681-C301 or prior to the beginning of LTS16371. | major thromboembolic events | NUMBER |
| PRIMARY | Time to First Major Thromboembolic Event | From Baseline up to 36 months | Analysis was performed on efficacy ITO population which included participants who were enrolled in LTS16371 and did not experience an aTTP recurrence in previous study ALX0681-C301 or prior to the beginning of LTS16371. | days | MEDIAN |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 outcomesResults by group114
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Acquired Thrombotic Thrombocytopenic Purpura (aTTP) Related Events | Standard of Care (SoC) (Treated in Study C301) | 37.9 | percentage of participants | ||
| Percentage of Participants With Acquired Thrombotic Thrombocytopenic Purpura (aTTP) Related Events | Caplacizumab (Treated in Study C301) | 8.2 | percentage of participants | ||
| Number of Acquired Thrombotic Thrombocytopenic Purpura-related Events | Standard of Care (SoC) (Treated in Study C301) | 11 | aTTP-related events | ||
| Number of Acquired Thrombotic Thrombocytopenic Purpura-related Events | Caplacizumab (Treated in Study C301) | 4 | aTTP-related events | ||
| Time to First Acquired Thrombotic Thrombocytopenic Purpura-related Events | Standard of Care (SoC) (Treated in Study C301) | NA | 95% Confidence Interval 845.00 to NA | days | |
| Time to First Acquired Thrombotic Thrombocytopenic Purpura-related Events | Caplacizumab (Treated in Study C301) | NA | 95% Confidence Interval NA to NA | days | |
| Number of Participants With aTTP Related Deaths Reported During the Study | Standard of Care (SoC) (Treated in Study C301) | 1 | Participants | ||
| Number of Participants With aTTP Related Deaths Reported During the Study | Caplacizumab (Treated in Study C301) | 0 | Participants | ||
| Percentage of Participants With Recurrence of Disease (aTTP) | Standard of Care (SoC) (Treated in Study C301) | 27.6 | percentage of participants | ||
| Percentage of Participants With Recurrence of Disease (aTTP) | Caplacizumab (Treated in Study C301) | 8.2 | percentage of participants |
1 to 10 of 114Source ClinicalTrials.gov
See all 114 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Standard of Care (SoC) (Treated in Study C301) | 29 | |
| Overall Study | STARTED | Caplacizumab (Treated in Study C301) | 75 | |
| Overall Study | COMPLETED | Standard of Care (SoC) (Treated in Study C301) | 23 | |
| Overall Study | COMPLETED | Caplacizumab (Treated in Study C301) | 70 | |
| Overall Study | NOT COMPLETED | Standard of Care (SoC) (Treated in Study C301) | 6 | |
| Overall Study | NOT COMPLETED | Caplacizumab (Treated in Study C301) | 5 |
Source ClinicalTrials.gov
Adverse events162
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 | Contusion | Injury, poisoning and procedural complications | Standard of Care (SoC) (Treated in Study C301) | 2 | 29 | 2 |
| other | Contusion | Injury, poisoning and procedural complications | Caplacizumab (Treated in Study C301) | 2 | 75 | 2 |
| other | Adamts13 Activity Decreased | Investigations | Standard of Care (SoC) (Treated in Study C301) | 0 | 29 | 0 |
| other | Adamts13 Activity Decreased | Investigations | Caplacizumab (Treated in Study C301) | 13 | 75 | 13 |
| other | Blood Cholesterol Increased | Investigations | Standard of Care (SoC) (Treated in Study C301) | 0 | 29 | 0 |
| other | Blood Cholesterol Increased | Investigations | Caplacizumab (Treated in Study C301) | 4 | 75 | 4 |
| other | Dizziness | Nervous system disorders | Standard of Care (SoC) (Treated in Study C301) | 2 | 29 | 2 |
| other | Dizziness | Nervous system disorders | Caplacizumab (Treated in Study C301) | 10 | 75 | 10 |
| other | Headache | Nervous system disorders | Standard of Care (SoC) (Treated in Study C301) | 9 | 29 | 9 |
| other | Headache | Nervous system disorders | Caplacizumab (Treated in Study C301) | 16 | 75 | 17 |
1 to 10 of 162Source ClinicalTrials.gov
See all 162 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Standard of Care (SoC) (Treated in Study C301) | 1 | 29 |
| Total, all-cause mortality | Caplacizumab (Treated in Study C301) | 0 | 75 |
| Total, other adverse events | Standard of Care (SoC) (Treated in Study C301) | 22 | 29 |
| Total, other adverse events | Caplacizumab (Treated in Study C301) | 58 | 75 |
| Total, serious adverse events | Standard of Care (SoC) (Treated in Study C301) | 16 | 29 |
| Total, serious adverse events | Caplacizumab (Treated in Study C301) | 28 | 75 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36138517 | DERIVED |
Source PubMed
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Caplacizumab (Treated in Study C301) vs Standard of Care (SoC) (Treated in Study C301): Number of Participants With aTTP Related Deaths Reported During the Study | Trial comparisons |
| Caplacizumab (Treated in Study C301) vs Standard of Care (SoC) (Treated in Study C301): deaths from any cause | Trial comparisons |
| Caplacizumab (Treated in Study C301) vs Standard of Care (SoC) (Treated in Study C301): serious adverse events | Trial comparisons |
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
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The record and each of its lists are JSON, twenty rows a page. No key.
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