CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 4 enrolled
Drug / intervention
BAX 888drug
Likely dose
BAX 888 single peripheral IV infusion (dose not specified in published record)AI-extracted
Key inclusion· 5
  • ✓Male, aged 18 to 75 years at screening
  • ✓Severe hemophilia A (FVIII activity <1% OR documented intron 1/22 inversion in F8 gene)
  • ✓≥3 hemorrhages in previous 12 months requiring FVIII treatment or prophylaxis
  • ✓History of >150 exposure days to exogenous FVIII concentrates or cryoprecipitate
Key exclusion· 24
  • ✕Bleeding disorder(s) other than hemophilia A
  • ✕Personal evidence of FVIII inhibitors (≥0.6 Bethesda units on any single test)
  • ✕Documented prior allergic reaction to any FVIII product
  • ✕Anti-AAV8 neutralizing antibody titer ≥1:5

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

Search/NCT03370172
NCT03370172Phase 2Completed
CompareCT.gov

A Global, Open-Label, Multicenter, Phase 1/2 Study of the Safety and Dose Escalation of BAX 888, an Adeno-Associated Virus Serotype 8 (AAV8) Vector Expressing B-Domain Deleted Factor VIII (BDD-FVIII) in Severe Hemophilia A Subjects Administered a Single Intravenous Infusion

Baxalta now part of Shire·interventional·Posted Dec 12, 2017·Updated Sep 11, 2025

In Brief

A Phase 2 clinical trial evaluating BAX 888 for Hemophilia A. Completed, enrolled 4 participants across 26 sites in 6 countries.

Detailed Summary

The main aim of this study is to check if there are side effects from BAX 888 and to determine the dose of BAX 888 for treating severe hemophilia A in male adults. Participants will receive one infusion with BAX 888 at the hemophilia treatment center. During the study, participants will visit their study clinic multiple times.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemophilia A
CountriesAustria, France, Germany, Hungary, Spain, United States
CollaboratorsBaxalta Innovations GmbH, now part of Shire, Takeda Development Center Americas, Inc.

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedDec 12, 2017
Enrollment StartFeb 27, 2018
Primary CompletionJul 9, 2024
TodayJul 2, 2026
Enrollment to primary: 6.4 yearsPosted 8.6 years ago

Interventions

BAX 888drug

Participants will receive a single peripheral IV infusion of BAX 888 in Cohort 1 and 2 Day 0.