Phase 3
Completed N=84
Trial to Evaluate the Effect of Secondary Prophylaxis With rFVIII Therapy in Severe Hemophilia A Adult and/or Adolescent Subjects Compared to That of Episodic Treatment
Source: ClinicalTrials.gov NCT00623480 ↗Enrolled (actual)
84
Serious AEs
23.8%
Results posted
Aug 2013
Primary outcomePrimary: Bleeding Frequency (Number of Total Bleeds) — 0; 54.5 Bleeds — p=<0.0001
Summary
To evaluate the effect of secondary prophylaxis as compared to episodic treatment on bleeding frequency (number of bleeds per year) and on joint damage.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bleeding Frequency (Number of Total Bleeds) |
0; 54.5 | <0.0001 sig |
| SECONDARY Change From Baseline to 3 Years in the MRI (Magnetic Resonance Imaging) Scale. |
0.79; 0.96 | 0.6614 |
| SECONDARY Change From Baseline to 3 Years in the Colorado Adult Joint Assessment Scale |
-0.31; 0.63 | 0.0072 sig |
Eligibility Criteria
Inclusion Criteria
- Males aged 12 to 50 years (US and Argentina)
- Males aged 18 to 50 years (other countries)
- Subjects with severe hemophilia A ( 0.6 BU is considered positive) or borderline (> 0.3 and 5xUpper Limit of Normal (ULN))
- Subjects on treatment with immunomodulatory agents within the last 3 months prior to study entry or during the study (the following drugs are however allowed: interferon-a treatment for Hepatitis C virus (HCV), Highly active anti-retroviral therapy (HAART) therapy for human immunodeficiency virus (HIV) and/or a total of two courses of pulse treatment with steroids for a maximum of 7 days at 1mg/kg or less)
- Subjects with an absolute CD4 lymphocyte cell count < 200 cells/mm3 (due to HIV, HCV or another suspected medical condition)
- Subjects with known hypersensitivity to rFVIII, mouse or hamster proteins
- Subjects who are receiving or had received other experimental drugs within 1 month prior to study entry
- Subjects who require any pre-medication to tolerate FVIII injections (e.g. anti-histamines)
- Subjects who are unwilling to comply with study visits or either of the possible treatment regimens
- Subjects who have a planned orthopedic intervention to be performed during the study that may substantially affect bleeding (e.g. surgical or chemical or radiological synovectomy)
- Subjects who are not suitable for participation in this study for any reason, according to the Investigator
- Subjects who have poor joint status as defined by routine need for a wheelchair or unable to ambulate without the assistance of a brace, cane or crutches
- Three or more joints that are already fused or "frozen" also called ankylosis
Data sourced from ClinicalTrials.gov (NCT00623480). 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.