CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 25 enrolled
Drug / intervention
Nonacog alfabiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04286412
NCT04286412Phase 4Completed
CompareCT.gov

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.

Pfizer·interventional·Posted Feb 27, 2020·Updated Jul 1, 2022

In Brief

A Phase 4 clinical trial evaluating Nonacog alfa for Hemophilia B. Completed, enrolled 25 participants across 5 sites.

Detailed 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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemophilia B
CountriesIndia
Collaborators--

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedFeb 27, 2020
Enrollment StartFeb 10, 2020
Primary CompletionSep 24, 2020
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 6.3 years ago

Interventions

Nonacog alfabiological

Nonacog alfa is indicated in India for the treatment and prophylaxis of bleeding in patients with hemophilia B (congenital factor IX deficiency).