Health Condition 1: D67- Hereditary factor IX deficiency
Conditions
Interventions
Intervention1: Nonacog alfa: Nonacog alfa will be administered prophylactically at a dose of 40 IU/kg (range 13 to
78 IU/kg) at intervals of 3 to 4 days in accordance with the approved Prescribing Inf
Sponsors
Pfizer Products India Private Limited Subsidiary of Pfizer Inc
Eligibility
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study: 1. Male subjects greater than or equal to 12 years to lesser than or equal to 65 years of age with a diagnosis of congenital moderately-severe to severe hemophilia B (FIX activity lesser than equals to 2%). 2. Documented history of at least 50 exposure days (EDs) to FIX-containing products. 3. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative, parent(s)/legal guardian) has been informed of all pertinent aspects of the study. For minors under the age of legal consent in India, assent of the participating child needs to be documented for the age range 12 to 18 in addition to the parental informed consent.
Exclusion criteria
Exclusion criteria: Subjects presenting with any of the following will not be included in the study: 1. Prior history of inhibitor to FIX or positive inhibitor testing (greater than or equal to 0.6 BU/mL) during Screening. Clinical signs or symptoms of decreased response to FIX. 2. Known hypersensitivity to the active substance or any of the excipients. 3. Known allergic reaction to hamster proteins. 4. Presence of any bleeding disorder in addition to hemophilia B. 5. Participation in other studies involving investigational drug(s) (Phases 1-4) within 30 days before the current study begins and/or during study participation. 6. Planned surgery within 6 months from the start of the study. 7. Unsuitable to participate in study for any other reason as assessed by the investigator; including any disorder, except for conditions associated with hemophilia B, which in the investigatorâ??s opinion might jeopardize subjectâ??s safety or compliance with the protocol. 8. Subjects (or a legally acceptable representative) is not able to understand study documents and study procedure. 9. Immunocompromised subjects due to human immunodeficiency virus (HIV) infection (defined as viral load above or equal to 100,000 copies/mL; and for HIV+ subjects: cluster of differentiation 4 positive (CD4+) lymphocyte count below or equal to 200/µL). HIV status and CD4+ lymphocyte count results may be obtained at screening or from available medical records; results must be not older than 6 months prior to screening. 10. Subjects who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the Investigator, subjects who have been previously enrolled into the study, or subjects who are Pfizer employees directly involved in the conduct of the study. 11. Planned use of any non-study medication for treatment of hemophilia (eg, other factor replacement agents, bypassing agents, or non-factor treatments [such as anti-tissue factor pathway inhibitors]).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To study the safety of nonacog alfa when administered for prophylaxis with respect to incidence of FIX inhibitor development.Timepoint: 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the incidence of adverse and serious adverse events, in particular, medically important events thrombotic events and hypersensitivity reactions), in subjects receiving a nonacog alfa prophylaxis, to evaluate the efficacy and the total annualized consumption in subjects receiving a nonacog alfa prophylaxis regimen and to evaluate the efficacy of nonacog alfa for the treatment of breakthrough bleeding episodes (on-demand treatment) while following a prophylaxis regimen.Timepoint: The secondary outcome will be assessed during the course of the study. | — |
Countries
India
Contacts
Public ContactDr Seema Pai
Pfizer India
Outcome results
None listed