Trials / Completed
CompletedNCT04286412
Nonacog Alfa Prophylaxis And Treatment Of Bleeding Episodes In Previously Treated Patients With Hemophilia B
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.
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- Male
- Age
- 12 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Nonacog alfa | Nonacog alfa is indicated in India for the treatment and prophylaxis of bleeding in patients with hemophilia B (congenital factor IX deficiency). |
Timeline
- Start date
- 2020-02-10
- Primary completion
- 2020-09-24
- Completion
- 2020-09-24
- First posted
- 2020-02-27
- Last updated
- 2022-07-01
- Results posted
- 2021-07-30
Locations
5 sites across 1 country: India
Source: ClinicalTrials.gov record NCT04286412. Inclusion in this directory is not an endorsement.