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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by Ablynx
Sponsor:
Information provided by (Responsible Party):
Ablynx
ClinicalTrials.gov Identifier:
NCT02553317
First received: September 14, 2015
Last updated: March 10, 2017
Last verified: March 2017
  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:


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:

  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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

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 March 22, 2017