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Follow-up Study for Patients Who Completed Study ALX0681-C301 (Post-HERCULES)

This study is currently recruiting participants.
See Contacts and Locations
Verified September 2017 by Ablynx
Sponsor:
Information provided by (Responsible Party):
Ablynx
ClinicalTrials.gov Identifier:
NCT02878603
First received: August 4, 2016
Last updated: September 7, 2017
Last verified: September 2017
  Purpose
The objective of this study is to evaluate long-term safety and efficacy of caplacizumab, to evaluate safety and efficacy of repeated use of caplacizumab and to characterize long term impact of TTP.

Condition Intervention Phase
Acquired Thrombotic Thrombocytopenic Purpura Biological: caplacizumab Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Follow-up Study for Patients Who Completed Study ALX0681-C301 (HERCULES) to Evaluate Long-term Safety and Efficacy of Caplacizumab (Post-HERCULES)

Resource links provided by NLM:


Further study details as provided by Ablynx:

Primary Outcome Measures:
  • Proportion of subjects with TTP-related events [ Time Frame: From screening until 36 months follow-up visit or until 7 days after end of treatment (whichever is the latest) ]
  • Number of TTP-related events [ Time Frame: From screening until 36 months follow-up visit or until 7 days after end of treatment (whichever is the latest) ]
  • Time to TTP-related event [ Time Frame: From screening until 36 months follow-up visit or until 7 days after end of treatment (whichever is the latest) ]
  • Mortality rate during the study [ Time Frame: From screening until 36 months follow-up visit or until 7 days after end of treatment (whichever is the latest) ]
  • Proportion of subjects with recurrence of disease [ Time Frame: From screening until 36 months follow-up visit or until 7 days after end of treatment (whichever is the latest) ]
  • Number of recurrences of disease [ Time Frame: From screening until 36 months follow-up visit or until 7 days after end of treatment (whichever is the latest) ]
  • Time to recurrence of disease [ Time Frame: From screening until 36 months follow-up visit or until 7 days after end of treatment (whichever is the latest) ]
  • Proportion of subjects with reported major thromboembolic events [ Time Frame: From screening until 36 months follow-up visit or until 7 days after end of treatment (whichever is the latest) ]
  • Number of major thromboembolic events [ Time Frame: From screening until 36 months follow-up visit or until 7 days after end of treatment (whichever is the latest) ]
  • Time to major thromboembolic event [ Time Frame: From screening until 36 months follow-up visit or until 7 days after end of treatment (whichever is the latest) ]
  • Change from baseline in cognitive function [ Time Frame: At screening and at 36 months follow-up visit ]
    Assessed by Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

  • Change from baseline in quality of life assessment [ Time Frame: From screening until 36 months follow-up visit or until 7 days after end of treatment (whichever is the latest) ]
    Assessed by SF36 questionnaire

  • Number of subjects with anti-drug antibodies [ Time Frame: From screening until 36 months follow-up visit or until 7 days after end of treatment (whichever is the latest) ]
  • Adverse events [ Time Frame: From screening until 36 months follow-up visit or until 7 days after end of treatment (whichever is the latest) ]

Estimated Enrollment: 92
Study Start Date: August 2016
Estimated Study Completion Date: July 2020
Estimated Primary Completion Date: July 2020 (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

  Eligibility

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

Inclusion Criteria:

  1. Completed the Final (28 day) FU visit in Study ALX0681-C301.
  2. Is ≥18 years of age at the time of signing the informed consent form (ICF).
  3. Provided informed consent prior to initiation of any study specific activity/procedure.
  4. Others as defined in the protocol

Exclusion Criteria:

  1. Not being able/willing to comply with the study protocol procedures.
  2. Currently enrolled in a clinical study with another investigational drug or device.
  3. 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: NCT02878603

Contacts
Contact: Ablynx NV Belgium clinicaltrials@ablynx.com

  Show 45 Study Locations
Sponsors and Collaborators
Ablynx
Investigators
Study Director: Medical Director Ablynx, MD Ablynx NV
  More Information

Responsible Party: Ablynx
ClinicalTrials.gov Identifier: NCT02878603     History of Changes
Other Study ID Numbers: ALX0681-C302
2016-001503-23 ( EudraCT Number )
Study First Received: August 4, 2016
Last Updated: September 7, 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 September 21, 2017