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ADVATE 2 mL Post-Authorization Safety Surveillance (PASS)

NCT02093741 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 65

Last updated 2021-03-17

No results posted yet for this study

Summary

This is a Post-Authorization Safety Surveillance (PASS) study designed to collect data on the safety and effectiveness of ADVATE reconstituted in 2 mL Sterile water for injection (SWFI) during routine clinical practice in children until 12 years of age. This surveillance study is a post-licensure commitment for ADVATE reconstituted in 2 mL SWFI.

Conditions

Interventions

BIOLOGICAL

Octocog alfa (recombinant human coagulation factor VIII) [ADVATE]

The investigators shall determine all treatment regimens according to product labeling information and standard practice.

Sponsors & Collaborators

  • Baxalta now part of Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Eligibility

Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-20
Primary Completion
2016-01-20
Completion
2016-01-20

Countries

  • France
  • Germany
  • Hungary
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT02093741 on ClinicalTrials.gov