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Trial record 2 of 4 for:    caplacizumab

Phase III Trial With Caplacizumab in Patients With Acquired Thrombotic Thrombocytopenic Purpura (HERCULES)

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ClinicalTrials.gov Identifier: NCT02553317
Recruitment Status : Completed
First Posted : September 17, 2015
Last Update Posted : May 15, 2018
Sponsor:
Information provided by (Responsible Party):
Ablynx

Brief Summary:
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 or disease Intervention/treatment Phase
Acquired Thrombotic Thrombocytopenic Purpura Biological: caplacizumab Biological: placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 145 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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
Actual Study Start Date : November 2015
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 :
  1. 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 ]
  2. 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) ]
  3. 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 ]
  4. 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

  5. (Serious) adverse events [ Time Frame: From Day 1 until last follow-up visit (28 days after last dosing) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult male or female ≥ 18 years of age at the time of signing the informed consent form (ICF).
  2. Clinical diagnosis of acquired TTP (initial or recurrent), which includes thrombocytopenia and microscopic evidence of red blood cell fragmentation (e.g., schistocytes).
  3. Requires initiation of daily PE treatment and has received 1 PE treatment prior to randomization
  4. Others as defined in the protocol

Exclusion Criteria:

  1. Platelet count ≥100×10E9/L.
  2. Serum creatinine level >200 µmol/L in case platelet count is > 30×10E9/L
  3. Known other causes of thrombocytopenia
  4. Congenital TTP (known at the time of study entry).
  5. Pregnancy or breast-feeding.
  6. 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02553317


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Locations
United States, Alabama
Investigator Site
Birmingham, Alabama, United States, 35249
United States, California
Investigator Site
Los Angeles, California, United States, 90033
United States, Georgia
Investigator Site
Atlanta, Georgia, United States, 30322
United States, Massachusetts
Investigator Site
Boston, Massachusetts, United States, 02114
United States, Missouri
Investigator Site
Saint Louis, Missouri, United States, 63110
United States, New York
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Rochester, New York, United States, 14642
Investigator Site
Rochester, New York, United States, 55905
Investigator Site
Valhalla, New York, United States, 10595
United States, North Carolina
Investigator Site
Chapel Hill, North Carolina, United States, 27599
Investigator Site
Durham, North Carolina, United States, 27710
Investigator Site
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Investigator SIte
Cleveland, Ohio, United States, 44195
Investigator Site
Columbus, Ohio, United States, 43210
United States, Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Investigator Site
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
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Charleston, South Carolina, United States, 29425
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Greenville, South Carolina, United States, 27834
United States, Texas
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Houston, Texas, United States, 77030
United States, Utah
Investigator Site
Salt Lake City, Utah, United States, 84112
Australia
Investigator Site
Brisbane, Australia, 4102
Investigator Site 1
Melbourne, Australia, 3050
Investigator Site 4
Melbourne, Australia, 3050
Investigator Site 3
Melbourne, Australia, 3084
Investigator Site 2
Melbourne, Australia, 3168
Investigator Site
Melbourne, Australia
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Perth, Australia, 6000
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Sydney, Australia, 2010
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Sydney, Australia
Austria
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Vienna, Austria
Belgium
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Antwerp, Belgium, 2060
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Brussels, Belgium
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Haine-Saint-Paul, Belgium, 7100
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La Louviere, Belgium, 7100
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Leuven, Belgium, 3000
Canada, Quebec
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Montreal, Quebec, Canada
Canada
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London, Canada
Investigator Site
Toronto, Canada
Czechia
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Brno, Czechia
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Hradec Kralove, Czechia
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Olomouc, Czechia
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Ostrava-Poruba, Czechia
France
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Caen, France
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Lille, France
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Marseille, France
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Nantes, France
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Paris, France, 75012
Investigator Site 1
Paris, France
Investigator Site 2
Paris, France
Investigator site 3
Paris, France
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Paris, France
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Rouen, France
Investigator Site
Salouel, France
Germany
Investigator site 1
Dresden, Germany
Investigator site 2
Dresden, Germany
Investigator site
Erlangen, Germany
Investigator site
Goppingen, Germany
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Kiel, Germany
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Köln, Germany
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Leipzig, Germany
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Würzburg, Germany
Hungary
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Budapest, Hungary, 1097
Investigator Site
Budapest, Hungary
Investigator Site
Debrecen, Hungary, 4032
Israel
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Be'er Ya`aqov, Israel
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Beer-Yaakov, Israel
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Haifa, Israel
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Jerusalem Region, Israel
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Jerusalem, Israel
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Nahariya, Israel
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Petah Tiqva, Israel
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Tel Aviv, Israel
Italy
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Catania, Italy
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Milan, Italy, 20122
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Milan, Italy
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Pesaro, Italy
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Rome, Italy
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Vicenza, Italy
Netherlands
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Amersfoort, Netherlands
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Leiden, Netherlands
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Rotterdam, Netherlands
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Veldhoven, Netherlands
Spain
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Barcelona, Spain, 08036
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Barcelona, Spain
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Madrid, Spain, 28007
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Sevilla, Spain, 41013
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Valencia, Spain, 46010
Investigator Site
Valencia, Spain, 46017
Investigator site 3
Valencia, Spain
Switzerland
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Bern, Switzerland
Investigator Site
Zurich, Switzerland
Turkey
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Ankara, Turkey
Investigator Site 1
Denizli, Turkey
Investigator Site 2
Denizli, Turkey
Investigator site 3
Denizli, Turkey
Investigator Site
Istanbul, Turkey
Investigator Site
Kayseri, Turkey
Investigator Site
Trabzon, Turkey
United Kingdom
Investigator Site
Bristol, United Kingdom
Investigator Site
Liverpool, United Kingdom
Investigator Site 1
London, United Kingdom
Investigator Site 2
London, United Kingdom
Sponsors and Collaborators
Ablynx
Investigators
Study Director: Medical Monitor Ablynx NV

Responsible Party: Ablynx
ClinicalTrials.gov Identifier: NCT02553317     History of Changes
Other Study ID Numbers: ALX0681-C301
2015-001098-42 ( EudraCT Number )
First Posted: September 17, 2015    Key Record Dates
Last Update Posted: May 15, 2018
Last Verified: May 2018

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