Human Cell Line-derived Recombinant Factor VIII (Human-cl-rhFVIII) in Previously Untreated Patients

NCT01712438 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2021-01-19

Study results available
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Summary

Investigate the inhibitor development rate of Human cl rhFVIII in previously untreated patients with severe Hemophilia A.

Conditions

  • Severe Hemophilia A

Interventions

BIOLOGICAL

Human cl rhFVIII

Sponsors & Collaborators

  • Octapharma

    lead INDUSTRY

Principal Investigators

  • Sigurd Knaub · Octapharma

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2018-12-14
Completion
2019-12-20

Countries

  • United States
  • Belarus
  • Canada
  • France
  • Georgia
  • Germany
  • India
  • Italy
  • Moldova
  • Morocco
  • Poland
  • Portugal
  • Russia
  • Slovenia
  • Spain
  • Ukraine
  • United Kingdom

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 NCT01712438 on ClinicalTrials.gov