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Clinical Study to Investigate the PK, Efficacy, and Safety of Wilate in Patients With Severe Hemophilia A

NCT02954575 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2021-01-19

Study results available
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Summary

The purpose of this study is to obtain additional data on the safety and efficacy of Wilate in PTPs with hemophilia A with at least 150 previous exposure days (EDs) to a FVIII concentrate who undergo prophylactic treatment with Wilate for 6 months and at least 50 EDs, thus supplementing the existing database to obtain approval of Wilate for the indication hemophilia A in the USA.

Conditions

  • Severe Hemophilia A

Interventions

DRUG

Wilate

Sponsors & Collaborators

  • Octapharma

    lead INDUSTRY

Principal Investigators

  • Cristina Solomon, MD · Octapharma

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2018-03-29
Completion
2018-03-29
FDA Drug
Yes

Countries

  • Bulgaria
  • Hungary
  • Poland
  • Romania
  • Russia

Study Locations

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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 NCT02954575 on ClinicalTrials.gov