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Clinical Trials/EUCTR2016-001503-23-AT
EUCTR2016-001503-23-AT
Active, not recruiting
Phase 1

Prospective Follow-up Study for Patients who Completed Study ALX0681-C301 (HERCULES) to Evaluate Long-term Safety and Efficacy of Caplacizumab (Post-HERCULES)

Ablynx NV0 sites104 target enrollmentJuly 14, 2016
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ConditionsAcquired thrombotic thrombocytopenic purpura (TTP)MedDRA version: 20.0Level: PTClassification code 10043648Term: Thrombotic thrombocytopenic purpuraSystem Organ Class: 10005329 - Blood and lymphatic system disordersTherapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Acquired thrombotic thrombocytopenic purpura (TTP)
Sponsor
Ablynx NV
Enrollment
104
Status
Active, not recruiting
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 14, 2016
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Ablynx NV

Eligibility Criteria

Inclusion Criteria

  • •Each potential subject must satisfy all of the following criteria to be enrolled in the study:
  • •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.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 95
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range 9

Exclusion Criteria

  • •The criteria for exclusion are the following:
  • •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.

Outcomes

Primary Outcomes

Not specified

Similar Trials

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Follow-up Study for Patients who Completed Study ALX0681-C301 (Post-HERCULES)
EUCTR2016-001503-23-GBAblynx NV104
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Phase 1
Follow-up Study for Patients who Completed Study ALX0681-C301 (Post-HERCULES)Acquired thrombotic thrombocytopenic purpura (TTP)MedDRA version: 20.0Level: PTClassification code 10043648Term: Thrombotic thrombocytopenic purpuraSystem Organ Class: 10005329 - Blood and lymphatic system disordersTherapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
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Follow-up Study for Patients who Completed Study ALX0681-C301 (Post-HERCULES)Acquired thrombotic thrombocytopenic purpura (TTP)MedDRA version: 20.0Level: PTClassification code 10043648Term: Thrombotic thrombocytopenic purpuraSystem Organ Class: 10005329 - Blood and lymphatic system disordersTherapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
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