# Pivotal Study (Pharmacokinetics, Efficacy, Safety) of BAX 326 (rFIX) in Hemophilia B Patients

> **NCT01174446** · PHASE3 · COMPLETED · sponsor: **Baxalta now part of Shire** · enrollment: 86 (actual)

## Conditions studied

- Hemophilia B

## Interventions

- **BIOLOGICAL:** BAX 326
- **BIOLOGICAL:** BeneFIX

## Key facts

- **NCT ID:** NCT01174446
- **Lead sponsor:** Baxalta now part of Shire
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2010-07-29
- **Primary completion:** 2012-05-03
- **Final completion:** 2012-05-03
- **Target enrollment:** 86 (ACTUAL)
- **Last updated:** 2021-05-20


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01174446

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01174446, "Pivotal Study (Pharmacokinetics, Efficacy, Safety) of BAX 326 (rFIX) in Hemophilia B Patients". Retrieved via AI Analytics 2026-06-08 from https://api.ai-analytics.org/clinical/NCT01174446. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*