Brief Title
Nonacog Alfa Prophylaxis And Treatment Of Bleeding Episodes In Previously Treated Patients With Hemophilia B
Official Title
A SINGLE COUNTRY, MULTICENTER, OPEN-LABEL AND NON-RANDOMIZED CLINICAL TRIAL WITH NONACOG ALFA PROPHYLAXIS AND TREATMENT OF BLEEDING EPISODES IN PREVIOUSLY TREATED PATIENTS WITH MODERATELY-SEVERE TO SEVERE HEMOPHILIA B FOR A DURATION OF 8 WEEKS.
Brief Summary
Nonacog alfa is indicated for the control and prevention of hemorrhagic episodes and for
routine and surgical prophylaxis in patients with hemophilia B. The current single country,
multi-centric, open label, non-randomized clinical trial is a post-approval study to fulfill
the Central Drugs Standard Control Organization (CDSCO) request for supplementary information
relating to the use of nonacog alfa in Indian subjects with hemophilia B.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
Percentage of Participants Who Developed Factor IX (FIX) Inhibitors
Secondary Outcome
Number of Participants With Serious Adverse Events (SAEs) and Medically Important Events (MIEs)
Condition
Hemophilia B
Intervention
Nonacog alfa
Study Arms / Comparison Groups
Treatment Arm
Description: At least twenty five eligible male subjects will be enrolled in the treatment arm to receive Nonacog alfa until 16 exposure days (EDs) or a period of up to 8 weeks on treatment had occurred (whichever occurs first).
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
25
Start Date
February 10, 2020
Completion Date
September 24, 2020
Primary Completion Date
September 24, 2020
Eligibility Criteria
Inclusion Criteria:
1. Male subjects ≥12 years to ≤65 years with a diagnosis of congenital moderately-severe
to severe hemophilia B (FIX activity ≤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:
1. Prior history of inhibitor to FIX or positive inhibitor testing (≥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 investigator's opinion might jeopardize subject'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]).
Gender
Male
Ages
12 Years - 65 Years
Accepts Healthy Volunteers
No
Contacts
Pfizer CT.gov Call Center, ,
Location Countries
India
Location Countries
India
Administrative Informations
NCT ID
NCT04286412
Organization ID
B1821059
Secondary IDs
2020-004430-38
Responsible Party
Sponsor
Study Sponsor
Pfizer
Study Sponsor
Pfizer CT.gov Call Center, Study Director, Pfizer
Verification Date
June 2022