# Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Recombinant Coagulation Factor VIII Fc Fusion Protein (rFVIIIFc) in Previously Treated Pediatric Subjects With Hemophilia A

> **NCT01458106** · PHASE3 · COMPLETED · sponsor: **Bioverativ Therapeutics Inc.** · enrollment: 71 (actual)

## Conditions studied

- Hemophilia A

## Interventions

- **DRUG:** BIIB031 (rFVIIIFc)
- **DRUG:** FVIII (PK subgroup only)

## Key facts

- **NCT ID:** NCT01458106
- **Lead sponsor:** Bioverativ Therapeutics Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2012-11
- **Primary completion:** 2013-12
- **Final completion:** 2013-12
- **Target enrollment:** 71 (ACTUAL)
- **Last updated:** 2020-12-19

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01458106

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01458106, "Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Recombinant Coagulation Factor VIII Fc Fusion Protein (rFVIIIFc) in Previously Treated Pediatric Subjects With Hemophilia A". Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/clinical/NCT01458106. Licensed CC0.

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