Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02878603
Recruitment Status : Active, not recruiting
First Posted : August 25, 2016
Last Update Posted : December 10, 2018
Sponsor:
Information provided by (Responsible Party):
Ablynx

Tracking Information
First Submitted Date  ICMJE August 4, 2016
First Posted Date  ICMJE August 25, 2016
Last Update Posted Date December 10, 2018
Actual Study Start Date  ICMJE October 2016
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2016)
  • 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) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02878603 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Follow-up Study for Patients Who Completed Study ALX0681-C301 (Post-HERCULES)
Official Title  ICMJE Prospective Follow-up Study for Patients Who Completed Study ALX0681-C301 (HERCULES) to Evaluate Long-term Safety and Efficacy of Caplacizumab (Post-HERCULES)
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acquired Thrombotic Thrombocytopenic Purpura
Intervention  ICMJE Biological: caplacizumab
Study Arms  ICMJE Experimental: caplacizumab
Initial i.v. dose followed by daily s.c. injections for a maximum period of 6 months
Intervention: Biological: caplacizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 9, 2017)
104
Original Estimated Enrollment  ICMJE
 (submitted: August 22, 2016)
92
Estimated Study Completion Date  ICMJE October 2020
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Belgium,   Canada,   Czechia,   France,   Hungary,   Israel,   Italy,   Spain,   Switzerland,   Turkey,   United Kingdom,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02878603
Other Study ID Numbers  ICMJE ALX0681-C302
2016-001503-23 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ablynx
Study Sponsor  ICMJE Ablynx
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Ablynx, MD Ablynx NV
PRS Account Ablynx
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP