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

NCT02878603 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2022-03-28

Study results available
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Summary

The objectives of this study were 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 acquired thrombotic thrombocytopenic purpura (aTTP).

Conditions

  • Acquired Thrombotic Thrombocytopenic Purpura

Interventions

BIOLOGICAL

Caplacizumab

OTHER

Standard of Care

• PE with plasma (e.g., fresh frozen plasma, solvent detergent/viral-inactivated plasma, cryosupernatant), • Corticosteroid treatment and • Use of other immunosuppressive agents (e.g., rituximab).

Sponsors & Collaborators

Principal Investigators

  • Medical Director Ablynx, MD · Ablynx NV

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-06
Primary Completion
2020-10-23
Completion
2020-10-23

Countries

  • United States
  • Austria
  • Belgium
  • Canada
  • Czechia
  • France
  • Hungary
  • Israel
  • Italy
  • Spain
  • Switzerland
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02878603 on ClinicalTrials.gov