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Phase III Trial With Caplacizumab in Patients With Acquired Thrombotic Thrombocytopenic Purpura (HERCULES)
This study is currently recruiting participants.
Verified March 2017 by Ablynx
Sponsor:
Ablynx
Information provided by (Responsible Party):
Ablynx
ClinicalTrials.gov Identifier:
NCT02553317
First received: September 14, 2015
Last updated: March 10, 2017
Last verified: March 2017
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Purpose
The study is a phase III, double blind, placebo-controlled, randomized study to evaluate the efficacy and safety of caplacizumab in more rapidly restoring normal platelet counts as measure of prevention of further microvascular thrombosis
| Condition | Intervention | Phase |
|---|---|---|
| Acquired Thrombotic Thrombocytopenic Purpura | Biological: caplacizumab Biological: placebo | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Participant, Care Provider, Investigator, Outcomes Assessor Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
thrombotic thrombocytopenic purpura
Genetic and Rare Diseases Information Center resources:
Thrombotic Thrombocytopenic Purpura, Acquired
U.S. FDA Resources
Further study details as provided by Ablynx:
Primary Outcome Measures:
- Time to platelet count response [ Time Frame: For maximum 6 months ]Initial platelet count ≥ 150×10E9/L with subsequent stop of daily plasma exchange within 5 days.
Secondary Outcome Measures:
- Proportion 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 (including extensions) [ Time Frame: From Day 1 until last dosing ]
- Proportion of subjects with a recurrence of TTP in the overall study period [ Time Frame: From Day 1 until last follow-up visit (28 days after last dosing) ]
- Proportion of subjects with refactory TTP, defined as absence of platelet count doubling after 4 days of standard treatment, and LDH > ULN [ Time Frame: Day 5 ]
- Time to normalization of all 3 of the following organ damage marker levels [ Time Frame: From Day 1 until last follow-up visit (28 days after last dosing) ]Time to normalization of all 3 of the following organ damage marker levels: Time to LDH equal or lower than 1 time the upper limit of normal (ULN) and cardiac Troponin I (cTnI) equal or lower than 1 time ULN and serum creatinine equal or lower than 1 time ULN
- (Serious) adverse events [ Time Frame: From Day 1 until last follow-up visit (28 days after last dosing) ]
| Estimated Enrollment: | 132 |
| Study Start Date: | September 2015 |
| Estimated Study Completion Date: | October 2017 |
| Estimated Primary Completion Date: | October 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: caplacizumab
Initial i.v. dose followed by daily s.c. injections for a maximum period of 6 months
|
Biological: caplacizumab
Other Name: ALX-0081
|
|
Placebo Comparator: placebo
Initial i.v. dose followed by daily s.c. injections for a maximum period of 6 months
|
Biological: placebo
Other Name: ALX-0081 placebo
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Adult male or female ≥ 18 years of age at the time of signing the informed consent form (ICF).
- Clinical diagnosis of acquired TTP (initial or recurrent), which includes thrombocytopenia and microscopic evidence of red blood cell fragmentation (e.g., schistocytes).
- Requires initiation of daily PE treatment and has received 1 PE treatment prior to randomization
- Others as defined in the protocol
Exclusion Criteria:
- 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
6. Others as defined in the protocol
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02553317
Show 92 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02553317
Contacts
| Contact: Ablynx NV Belgium | clinicaltrials@ablynx.com |
Show 92 Study Locations
Sponsors and Collaborators
Ablynx
Investigators
| Study Director: | Medical Monitor | Ablynx NV |
More Information
| Responsible Party: | Ablynx |
| ClinicalTrials.gov Identifier: | NCT02553317 History of Changes |
| Other Study ID Numbers: |
ALX0681-C301 2015-001098-42 ( EudraCT Number ) |
| Study First Received: | September 14, 2015 |
| Last Updated: | March 10, 2017 |
Additional relevant MeSH terms:
|
Purpura Purpura, Thrombocytopenic Purpura, Thrombotic Thrombocytopenic Blood Coagulation Disorders Hematologic Diseases Hemorrhage Pathologic Processes |
Skin Manifestations Signs and Symptoms Thrombotic Microangiopathies Thrombocytopenia Blood Platelet Disorders Immune System Diseases Thrombophilia |
ClinicalTrials.gov processed this record on June 22, 2017