---
title: Study Evaluating rFIX; BeneFIX in Severe Hemophilia B
nct_id: NCT00037557
overall_status: COMPLETED
phase: PHASE3
sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
study_type: INTERVENTIONAL
primary_condition: Hemophilia B
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00037557.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00037557"
ct_last_update_post_date: 2007-12-27
last_seen_at: "2026-05-12T06:28:45.213Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Study Evaluating rFIX; BeneFIX in Severe Hemophilia B

**Official Title:** An Open-Label, Single-Arm, Safety and Efficacy Study of Recombinant Human Factor IX (rFIX; BeneFIX®) in Children Less Than 6 Years of Age With Severe Hemophilia B

**NCT ID:** [NCT00037557](https://clinicaltrials.gov/study/NCT00037557)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 20
- **Lead Sponsor:** Wyeth is now a wholly owned subsidiary of Pfizer
- **Conditions:** Hemophilia B
- **Start Date:** 2002-09
- **Completion Date:** 2007-11
- **CT.gov Last Update:** 2007-12-27

## Brief Summary

To characterize the safety and efficacy of rFIX in children less than 6 years of age with severe hemophilia B in the setting of acute bleeding episodes, prophylaxis, and/or surgery.

This study will provide an opportunity for systematic observation of treatment with rFIX in children less than 6 years of age regardless of prior FIX treatment. Younger patients exhibit a different pharmacokinetic profile and therefore may respond differently to rFIX infusions when compared with older children and adults. This evaluation will provide data from which recommendations can be made regarding rFIX dosing and treatment of these patients. Surveillance for certain observations that have been made in patients treated with rFIX in the clinical and postmarketing setting will be performed, including inhibitor development, thrombogenicity, FIX recovery/lack of effect, allergic-type manifestations, and RBC agglutination. Comparisons will be derived from published reports and communications describing experience with other FIX products and protein therapeutics in general.

## Eligibility

- **Maximum age:** 5 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Severe hemophilia B
* Less than 5 years of age
* In the investigator's judgment, the patient and/or caregiver will be compliant to study procedures

Exclusion Criteria:

* A currently detectable FIX inhibitor. A family history of inhibitors will not exclude the patient.
* Impaired liver function
* Impaired renal function
```

## Interventions

- **BeneFIX** (DRUG)

## Primary Outcomes

- **To characterize the safety and efficacy of rFIX in children less than 6 years of age with severe hemophilia B in the setting of acute bleeding episodes, prophylaxis, and/or surgery.**

## Secondary Outcomes

- **To measure the incremental recovery of rFIX in children following a 75-IU/kg bolus infusion.**

## Locations (6)

- Aurora, Colorado, United States
- Detroit, Michigan, United States
- New Brunswick, New Jersey, United States
- Chapel Hill, North Carolina, United States
- Dayton, Ohio, United States
- Houston, Texas, United States

## Recent Field Changes (last 30 days)

- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.|aurora|colorado|united states` — added _(2026-05-12)_
- `locations.|detroit|michigan|united states` — added _(2026-05-12)_
- `locations.|new brunswick|new jersey|united states` — added _(2026-05-12)_
- `locations.|chapel hill|north carolina|united states` — added _(2026-05-12)_
- `locations.|dayton|ohio|united states` — added _(2026-05-12)_
- `locations.|houston|texas|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00037557.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00037557*  
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