Severe or Moderate Hemophilia A with or without factor VIII inhibitors
Conditions
Brief summary
1. Incidence and severity of adverse events with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5 .0 (NCI CTCAE v5.0), 2. Change from baseline in selected clinical laboratory test results, 3. Change from baseline in vital signs and electrocardiogram (ECG) parameters
Detailed description
1. Plasma concentration of NXT007 at specified timepoints and relevant pharmacokinetic (PK) parameters, 2. Prevalence of anti-drug antibodies (ADAs) at baseline and incidence of ADAs during the study, 3. Number and proportion of participants with anti-FVIII inhibitors (titer >= 0.6 BU/mL) at specified timepoints, 4. Number of bleeding events over time, 5. Annualized bleeding rate (ABR) for treated bleeds, all bleeds, treated spontaneous bleeds, and treated joint bleeds
Interventions
DRUGNXT007
Sponsors
F. Hoffmann-La Roche AG
Eligibility
Sex/Gender
Male
Age
0 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Incidence and severity of adverse events with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5 .0 (NCI CTCAE v5.0), 2. Change from baseline in selected clinical laboratory test results, 3. Change from baseline in vital signs and electrocardiogram (ECG) parameters | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Plasma concentration of NXT007 at specified timepoints and relevant pharmacokinetic (PK) parameters, 2. Prevalence of anti-drug antibodies (ADAs) at baseline and incidence of ADAs during the study, 3. Number and proportion of participants with anti-FVIII inhibitors (titer >= 0.6 BU/mL) at specified timepoints, 4. Number of bleeding events over time, 5. Annualized bleeding rate (ABR) for treated bleeds, all bleeds, treated spontaneous bleeds, and treated joint bleeds | — |
Countries
Italy, Poland, Spain
Outcome results
None listed