Acquired Thrombotic Thrombocytopenic PurpuraPhase 3HERCULESNCT02553317
Phase III Trial With Caplacizumab in Patients With Acquired Thrombotic Thrombocytopenic Purpura
A Phase 3 study testing Caplacizumab in people with Acquired Thrombotic Thrombocytopenic Purpura, run by Ablynx, a Sanofi company at 101 sites in 16 countries.
Trial summary
The study was a Phase III, double-blind, placebo-controlled, randomized study to evaluate the efficacy of caplacizumab in more rapidly restoring normal platelet counts as measure of prevention of further microvascular thrombosis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acquired Thrombotic Thrombocytopenic Purpura
- What is being tested?
- Caplacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 145 participants
- Where
- 101 sitesin 16 countries
- Study dates
- Nov 2015to Aug 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male or female ≥ 18 years of age at the time of signing the informed consent form (ICF).
- Clinical diagnosis of acquired thrombotic thrombocytopenic purpura (aTTP) (initial or recurrent), which included thrombocytopenia and microscopic evidence of red blood cell fragmentation (e.g., schistocytes).
- Required initiation of daily PE treatment and had received 1 PE treatment prior to randomization
- Others as defined in the protocol
Who cannot join
- Platelet count ≥100×10E9/L.
- Serum creatinine level >200 µmol/L in case platelet count is > 30×10E9/L
- Known other causes of thrombocytopenia
- Congenital TTP (known at the time of study entry).
- Pregnancy or breast-feeding.
- Subjects who were previously enrolled in a clinical study with caplacizumab and received caplacizumab or for whom the assigned treatment arm is unknown
- Others as defined in the protocol
Trial locations and contacts
101 sites in 16 countries.
101 sites in 16 countries
United States19 sites
Investigator Site
Atlanta, Georgia, 30322
Investigator Site
Birmingham, Alabama, 35249
Investigator Site
Boston, Massachusetts, 02114
Investigator Site
Chapel Hill, North Carolina, 27599
Investigator Site
Charleston, South Carolina, 29425
Investigator SIte
Cleveland, Ohio, 44195
Investigator Site
Columbus, Ohio, 43210
Investigator Site
Durham, North Carolina, 27710
Investigator Site
Greenville, South Carolina, 27834
Investigator Site
Houston, Texas, 77030
Investigator Site
Los Angeles, California, 90033
Investigator Site
Oklahoma City, Oklahoma, 73104
Investigator Site
Pittsburgh, Pennsylvania, 15213
Investigator Site
Rochester, New York, 14642
Investigator Site
Rochester, New York, 55905
Investigator Site
Salt Lake City, Utah, 84112
Investigator Site
St Louis, Missouri, 63110
Investigator Site
Valhalla, New York, 10595
Investigator Site
Winston-Salem, North Carolina, 27157
France11 sites
Investigator Site
Caen
Investigator Site
Lille
Investigator Site
Marseille
Investigator Site
Nantes
Investigator Site 1
Paris
Investigator Site 2
Paris
Investigator Site 3
Paris
Investigator Site 4
Paris
Investigator site 5
Paris
Investigator Site
Rouen
Investigator Site
Salouël
Australia9 sites
Investigator Site
Brisbane
Investigator Site 1
Melbourne
Investigator Site 2
Melbourne
Investigator Site 3
Melbourne
Investigator Site 4
Melbourne
Investigator Site 5
Melbourne
Investigator Site
Perth
Investigator Site 1
Sydney
Investigator Site 2
Sydney
Germany8 sites
Investigator site
Cologne
Investigator site 1
Dresden
Investigator site 2
Dresden
Investigator site
Erlangen
Investigator site
Göppingen
Investigator site
Kiel
Investigator site
Leipzig
Investigator site
Würzburg
Israel8 sites
Investigator Site 1
Be’er Ya‘aqov
Investigator Site 2
Be’er Ya‘aqov
Investigator Site
Haifa
Investigator Site 1
Jerusalem
Investigator Site 2
Jerusalem
Investigator Site
Nahariya
Investigator Site
Petah Tikva
Investigator Site
Tel Aviv
Spain7 sites
Investigator Site 1
Barcelona
Investigator Site 2
Barcelona
Investigator Site
Madrid
Investigator Site
Seville
Investigator Site 1
Valencia
Investigator Site 2
Valencia
Investigator site 3
Valencia
Turkey (Türkiye)7 sites
Investigator Site
Ankara
Investigator Site 1
Denizli
Investigator Site 2
Denizli
Investigator site 3
Denizli
Investigator Site
Istanbul
Investigator Site
Kayseri
Investigator Site
Trabzon
Italy6 sites
Investigator Site
Catania
Investigator Site 1
Milan
Investigator Site 2
Milan
Investigator Site
Pesaro
Investigator Site
Rome
Investigator Site
Vicenza
Belgium5 sites
Investigator Site
Antwerp
Investigator Site
Brussels
Investigator Site
Haine-Saint-Paul
Investigator Site
La Louvière
Investigator Site
Leuven
Czechia4 sites
Investigator Site
Brno
Investigator Site
Hradec Králové
Investigator Site
Olomouc
Investigator Site
Ostrava-Poruba
Netherlands4 sites
Investigator Site
Amersfoort
Investigator Site
Leiden
Investigator Site
Rotterdam
Investigator Site
Veldhoven
United Kingdom4 sites
Investigator Site
Bristol
Investigator Site
Liverpool
Investigator Site 1
London
Investigator Site 2
London
Canada3 sites
Investigator Site
London
Invesigator Site
Montreal, Quebec
Investigator Site
Toronto
Hungary3 sites
Investigator Site 1
Budapest
Investigator Site 2
Budapest
Investigator Site
Debrecen
About this study
Official title: A Phase III Double-blind, Randomized, Parallel Group, Multicenter Placebo-controlled Trial to Study the Efficacy and Safety of Caplacizumab in Patients With Acquired Thrombotic Thrombocytopenic Purpura
The study was a Phase III, double-blind, placebo-controlled, randomized study to evaluate the efficacy of caplacizumab in more rapidly restoring normal platelet counts as measure of prevention of further microvascular thrombosis
- Being tested
- Caplacizumab, Placebo
- Medical subject headings
- Purpura, Thrombotic Thrombocytopenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaplacizumabBiological
Also called ALX-0081
- First day of treatment: 10 mg intravenous (i.v.) injection prior to plasma exchange (PE) followed by a 10 mg subcutaneous (s.c.) injection (in the abdominal region) after completion of PE on that day.
- Subsequent days of treatment during PE: daily 10 mg s.c. injection (in the abdominal region) following PE.
- Treatment after PE period: daily 10 mg s.c. injections for 30 days. If the underlying immunological disease was not resolved, treatment could be extended for a maximum of 4 additional 1-week periods (i.e., 28 days) and was to be accompanied by optimization of immunosuppression.
PlaceboBiological
Also called ALX-0081 Placebo
- First day of treatment: i.v. injection prior to PE followed by a s.c. injection (in the abdominal region) after completion of PE on that day.
- Subsequent days of treatment during PE: daily s.c. injection (in the abdominal region) following PE.
- Treatment after PE period: daily s.c. injections for 30 days. If the underlying immunological disease was not resolved, treatment could be extended for a maximum of 4 additional 1-week periods (i.e., 28 days) and was to be accompanied by optimization of immunosuppression.
| Study group | Role | What they receive |
|---|---|---|
| Caplacizumab | Experimental | Caplacizumab 10 mg once daily Receives: Biological: Caplacizumab |
| Placebo | Placebo comparator | Placebo once daily Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Platelet Count Response
Platelet count response was defined as initial platelet count ≥ 150,000/μL with subsequent stop of daily PE within 5 days. It refers to the first time both conditions, platelet count ≥ 150,000/μL and the stop of daily PE within 5 days, were met.
Measured: Only data from the DB daily PE period (median = 5 days) up to the cut-off were used. The cut-off point was defined by whichever occured first: 1) 45 days of daily PE after start of study drug, 2) stop of daily PE, 3) stop of study drug (median = 34 days)
Secondary outcomes (4)
Number and Percentage of Subjects With TTP-Related Death, Recurrence of TTP, or a Major Thromboembolic Event During the Study Drug Treatment Period
Number and percentage of subjects with TTP-related death, a recurrence of TTP, or at least one treatment-emergent major thromboembolic event during the study drug treatment period (i.e., first key secondary endpoint).
Measured: The study drug treatment period, a median (min, max) of 36 (2, 82) days. For both treatment groups, only events that occurred prior to a switch to open-label caplacizumab were evaluated for this analysis.
Number and Percentage of Subjects With a Recurrence of TTP in the Overall Study Period
Number and percentage of subjects with a recurrence of TTP during the Overall Study Period (i.e., including follow-up [FU]) (i.e., second key secondary endpoint).
Measured: The overall study period (covers both the overall treatment period and the follow-up period), a median (min, max) of 65 (2, 110) days.
Number and Percentage of Subjects With Refractory Disease
Number and percentage of subjects with refractory TTP, defined as absence of platelet count doubling after 4 days of standard treatment, and lactate dehydrogenase (LDH) > upper limit of normal (ULN) (i.e., third key secondary endpoint).
Measured: The study drug treatment period, a median (min, max) of 36 (2, 82) days.
Time to Normalization of Organ Damage Marker Levels
Time to first normalization of LDH, cardiac troponin I (cTnI) and serum creatinine was defined as: first time of LDH ≤ ULN and cTnI ≤ ULN and serum creatinine ≤ ULN - time of first i.v. loading dose of study drug after randomization + 1 minute. Subjects in either initial treatment group who switched to open-label caplacizumab before having reached the endpoint were censored at time of switch.
Of note, the key secondary endpoints were hierarchically ordered to allow statistical testing for these endpoints at the same nominal significance level of 5% without adjustment, as long as the tests occurred in the pre-defined sequential order, and given that all null hypotheses tested for endpoints with a higher rank (including the primary endpoint) were rejected. No confirmatory testing was done for this fourth key secondary endpoint, as the statistical test was not significant for the proportion of subjects with refractory disease (i.e., the third key secondary endpoint).
Measured: Overall study period, a median (min, max) of 65 (2, 110) days. For both treatment groups, normalizations occurring during the open-label period were not evaluated in this analysis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2015 (estimated)
- Study startNov 2015
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acquired Thrombotic Thrombocytopenic PurpuraStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ablynx, a Sanofi company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Ablynx NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02553317
- Sponsor's protocol ID
- ALX0681-C301
- Other IDs
- 2015-001098-42, 2015
- Acronym
- HERCULES
- Status last verified
- May 2019
- First submitted
- 14 Sep 2015
- Last updated
- 5 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Publications
Peyvandi F, Cataland S, Scully M, Coppo P, Knoebl P, Kremer Hovinga JA, Metjian A, de la Rubia J, Pavenski K, Minkue Mi Edou J, De Winter H, Callewaert F. Caplacizumab prevents refractoriness and mortality in acquired thrombotic thrombocytopenic purpura: integrated analysis. Blood Adv. 2021 Apr 27;5(8):2137-2141. doi: 10.1182/bloodadvances.2020001834.
PubMed 33881463Knoebl P, Cataland S, Peyvandi F, Coppo P, Scully M, Kremer Hovinga JA, Metjian A, de la Rubia J, Pavenski K, Minkue Mi Edou J, De Winter H, Callewaert F. Efficacy and safety of open-label caplacizumab in patients with exacerbations of acquired thrombotic thrombocytopenic purpura in the HERCULES study. J Thromb Haemost. 2020 Feb;18(2):479-484. doi: 10.1111/jth.14679. Epub 2019 Dec 9.
PubMed 31691462Scully M, Cataland SR, Peyvandi F, Coppo P, Knobl P, Kremer Hovinga JA, Metjian A, de la Rubia J, Pavenski K, Callewaert F, Biswas D, De Winter H, Zeldin RK; HERCULES Investigators. Caplacizumab Treatment for Acquired Thrombotic Thrombocytopenic Purpura. N Engl J Med. 2019 Jan 24;380(4):335-346. doi: 10.1056/NEJMoa1806311. Epub 2019 Jan 9.
PubMed 30625070
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Double-blind, Randomized, Parallel Group, Multicenter Placebo-controlled Trial to Study the Efficacy and Safety of Caplacizumab in Patients With Acquired Thrombotic Thrombocytopenic Purpura
- ClinicalTrials.gov ID
- NCT02553317
- Acronym / sponsor ID
- HERCULES / ALX0681-C301
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Ablynx, a Sanofi companyIndustry (pharma, biotech, devices)
- Study start
- Nov 2015 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 17 Sep 2015 (estimated)
- Results
- Posted 22 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study was a Phase III, double-blind, placebo-controlled, randomized study to evaluate the efficacy of caplacizumab in more rapidly restoring normal platelet counts as measure of prevention of further microvascular thrombosis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caplacizumab | Experimental | Biological: CaplacizumabCaplacizumab 10 mg once daily |
| Placebo | Placebo comparator | Biological: PlaceboPlacebo once daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult male or female ≥ 18 years of age at the time of signing the informed consent form (ICF).
- Clinical diagnosis of acquired thrombotic thrombocytopenic purpura (aTTP) (initial or recurrent), which included thrombocytopenia and microscopic evidence of red blood cell fragmentation (e.g., schistocytes).
- Required initiation of daily PE treatment and had received 1 PE treatment prior to randomization
- Others as defined in the protocol
Key exclusion criteria (7 listed)
- Platelet count ≥100×10E9/L.
- Serum creatinine level >200 µmol/L in case platelet count is > 30×10E9/L
- Known other causes of thrombocytopenia
- Congenital TTP (known at the time of study entry).
- Pregnancy or breast-feeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CaplacizumabAlso: ALX-0081* First day of treatment: 10 mg intravenous (i.v.) injection prior to plasma exchange (PE) followed by a 10 mg subcutaneous (s.c.) injection (in the abdominal region) after completion of PE on that day. * Subsequent days of treatment during PE: daily 10 mg s.c. injection (in the abdominal region) following PE. * Treatment after PE period: daily 10 mg s.c. injections for 30 days. If the underlying immunological disease was not resolved, treatment could be extended for a maximum of 4 additional 1-week periods (i.e., 28 days) and was to be accompanied by optimization of immunosuppression. | Biological | Caplacizumab |
| PlaceboAlso: ALX-0081 Placebo* First day of treatment: i.v. injection prior to PE followed by a s.c. injection (in the abdominal region) after completion of PE on that day. * Subsequent days of treatment during PE: daily s.c. injection (in the abdominal region) following PE. * Treatment after PE period: daily s.c. injections for 30 days. If the underlying immunological disease was not resolved, treatment could be extended for a maximum of 4 additional 1-week periods (i.e., 28 days) and was to be accompanied by optimization of immunosuppression. | Biological | Placebo |
Primary outcome
Time to Platelet Count Response
Time frame: Only data from the DB daily PE period (median = 5 days) up to the cut-off were used. The cut-off point was defined by whichever occured first: 1) 45 days of daily PE after start of study drug, 2) stop of daily PE, 3) stop of study drug (median = 34 days)
Platelet count response was defined as initial platelet count ≥ 150,000/μL with subsequent stop of daily PE within 5 days. It refers to the first time both conditions, platelet count ≥ 150,000/μL and the stop of daily PE within 5 days, were met.
4 secondary outcomes
Number and Percentage of Subjects With TTP-Related Death, Recurrence of TTP, or a Major Thromboembolic Event During the Study Drug Treatment Period
Time frame: The study drug treatment period, a median (min, max) of 36 (2, 82) days. For both treatment groups, only events that occurred prior to a switch to open-label caplacizumab were evaluated for this analysis.
Number and Percentage of Subjects With a Recurrence of TTP in the Overall Study Period
Time frame: The overall study period (covers both the overall treatment period and the follow-up period), a median (min, max) of 65 (2, 110) days.
Number and Percentage of Subjects With Refractory Disease
Time frame: The study drug treatment period, a median (min, max) of 36 (2, 82) days.
Time to Normalization of Organ Damage Marker Levels
Time frame: Overall study period, a median (min, max) of 65 (2, 110) days. For both treatment groups, normalizations occurring during the open-label period were not evaluated in this analysis.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33881463Peyvandi F, Cataland S, Scully M, Coppo P, Knoebl P, Kremer Hovinga JA, Metjian A, de la Rubia J, Pavenski K, Minkue Mi Edou J, De Winter H, Callewaert F. Caplacizumab prevents refractoriness and mortality in acquired thrombotic thrombocytopenic purpura: integrated analysis. Blood Adv. 2021 Apr 27;5(8):2137-2141. doi: 10.1182/bloodadvances.2020001834.
- Derived from this study: PubMed 31691462Knoebl P, Cataland S, Peyvandi F, Coppo P, Scully M, Kremer Hovinga JA, Metjian A, de la Rubia J, Pavenski K, Minkue Mi Edou J, De Winter H, Callewaert F. Efficacy and safety of open-label caplacizumab in patients with exacerbations of acquired thrombotic thrombocytopenic purpura in the HERCULES study. J Thromb Haemost. 2020 Feb;18(2):479-484. doi: 10.1111/jth.14679. Epub 2019 Dec 9.
- Derived from this study: PubMed 30625070Scully M, Cataland SR, Peyvandi F, Coppo P, Knobl P, Kremer Hovinga JA, Metjian A, de la Rubia J, Pavenski K, Callewaert F, Biswas D, De Winter H, Zeldin RK; HERCULES Investigators. Caplacizumab Treatment for Acquired Thrombotic Thrombocytopenic Purpura. N Engl J Med. 2019 Jan 24;380(4):335-346. doi: 10.1056/NEJMoa1806311. Epub 2019 Jan 9.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Ablynx NV
101 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Caplacizumab in people with Acquired Thrombotic Thrombocytopenic Purpura, run by Ablynx, a Sanofi company at 101 sites in 16 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 101 sites in United States, France, Australia, Germany, Israel and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Platelet Count Response (time frame: Only data from the DB daily PE period (median = 5 days) up to the cut-off were used. The cut-off point was defined by whichever occured first: 1) 45 days of daily PE after start of study drug, 2) stop of daily PE, 3) stop of study drug (median = 34 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02553317, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2023.