Phase 3 Completed N=3 Treatment

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

Hemophilia A

Source: ClinicalTrials.gov NCT01341912 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2014

Primary outcomePrimary: Long-term Immunogenicity — 0 occurrence of inhibitors

Summary

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Long-term Immunogenicity	—	—
SECONDARY To Determine Long-term Efficacy of Human-cl rhFVIII in the Treatment of Bleeding Episodes and in Surgical Prophylaxis	71.88; 26.56; 1.56; 0	—

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

Development of FVIII inhibitors ( 5 times of upper limit of normal, creatine >120 micro mol/L) during the course of the GENA-01 study

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01341912). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.