Study to Investigate the Long-term Efficacy and Safety of Human-cl rhFVIII in Previously Treated Patients (PTPs)

Completed · Phase 3

Conditions studied: Severe Hemophilia A

In brief

The purpose of the study is to study the long-term efficacy, safety and tolerability of Human-cl rhFVIII in previously treated patients with severe hemophilia A.

Key facts

Study ID

NCT01341912

Run by

Octapharma

People needed

3

Starts

2011-06-01

Expected to finish

2012-08-01

Last updated by the study team

2020-03-17

Who can join

Age: 12 and older, up to 65. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Completion of GENA-01 study with at least 50 Exposure Days (EDs) and at least 6 months study participation and immediate enrollment into GENA-11

You may not qualify if…

• Development of FVIII inhibitors (<=0.6 BU), during the course of the GENA-01 study
• Development of any severe liver or kidney disease (ALT and AST level > 5 times of upper limit of normal, creatine >120 micro mol/L) during the course of the GENA-01 study

Where it is running

• Georgetown University — Washington D.C., District of Columbia, United States
• Haematological Hospital SHAT "Joan Pavel" — Sofia, Bulgaria

Full record on ClinicalTrials.gov

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