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Fc factOrs and Real-World hemophiliA Patient-ReporteD Outcomes

NCT02392156 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 3

Last updated 2020-12-19

No results posted yet for this study

Summary

The primary objective of the study is to evaluate the effectiveness of prophylactic treatment with recombinant Factor VIII Fc fusion protein (rFVIIIFc) and recombinant Factor IX Fc fusion protein (rFIXFc) therapy as assessed by patient treatment burden and health economic outcomes while maintaining disease control in males with hemophilia A or B.

Conditions

Interventions

BIOLOGICAL

rFVIIIFc

As described in the treatment arm

BIOLOGICAL

rFIXFc

As described in the treatment arm

DRUG

non-Fc FVIII replacement products

Standard plasma-derived (pd) or recombinant (r) FVIII concentrate and other traditional treatment options

DRUG

non-Fc FIX replacement products

Standard plasma-derived (pd) or recombinant (r) FIX concentrate and other traditional treatment options

Sponsors & Collaborators

  • Swedish Orphan Biovitrum

    collaborator INDUSTRY

  • Bioverativ Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Director · Bioverativ Therapeutics Inc.

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • United States

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 NCT02392156 on ClinicalTrials.gov