Phase 3 N=48 Treatment

Study to Investigate Immunogenicity, Efficacy and Safety of Treatment With Human-cl rhFVIII

Severe Hemophilia A

Bottom Line

View on ClinicalTrials.gov: NCT01992549 ↗

Enrolled (actual)

Serious AEs

10.4%

Results posted

Dec 2019

Primary outcome: Primary: Immunogenicity of Human-cl rhFVIII: Incidence of Inhibitors — 0 participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Human-cl rhFVIII (Biological)
Age: Pediatric, Adult, Older Adult
Sex: Male
Sponsor: Octapharma
Primary completion: Dec 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Immunogenicity of Human-cl rhFVIII: Incidence of Inhibitors	—	—
SECONDARY Frequency of Spontaneous Break-through Bleeds	0.283	—
SECONDARY Efficacy of Human-cl rhFVIII for the Treatment of Bleeds	58; 28; 21; 3; 1	—
SECONDARY Efficacy of Human-cl rhFVIII for Surgical Prophylaxis	0; 2; 2; 0; 0; 0	—
SECONDARY The Occurrence of Any Adverse Event (AE)	29; 5; 3; 20; 0; 1	—

Summary

The purpose of the study is to collect long-term data on the inhibitor development rate of Human-cl rhFVIII in previously untreated patients with severe Hemophilia A.

Eligibility Criteria

Inclusion Criteria

Patients who completed GENA-05 in accordance with the study protocol

Exclusion Criteria

Severe liver or kidney disease
Concomitant treatment with any systemic immunosuppressive drug;
Other FVIII concentrate than Human-cl rhFVIII was received between completion visit of GENA-05 and start of GENA-15 (except emergency cases).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01992549). 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.