CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 85 enrolled
Drug / intervention
Intravenous infusions of Xynthadrug
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/NCT02492984
NCT02492984Phase 4Completed
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An Open-label, Single-arm, Post- Authorization Pragmatic Clinical Trial On The Safety And Efficacy Of Xyntha (Moroctocog-alfa (Af-cc), Recombinant Fviii) In Subjects With Hemophilia A In Usual Care Settings In China

Pfizer·interventional·Posted Jul 9, 2015·Updated Apr 4, 2017

In Brief

A Phase 4 clinical trial evaluating Intravenous infusions of Xyntha for Hemophilia A. Completed, enrolled 85 participants across 15 sites.

Detailed Summary

An open-label, single-arm, post- authorization pragmatic clinical trial on the safety and efficacy of Xyntha (Moroctocog-alfa (AF-CC), Recombinant FVIII) in subjects with hemophilia A in usual care settings in China for approximately 6 months or or approximately 50 exposure days whichever occurs first

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemophilia A
CountriesChina
Collaborators--

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 9, 2015
Enrollment StartApr 1, 2015
Primary CompletionJul 1, 2016
Study CompletionAug 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 11.0 years ago

Interventions

Intravenous infusions of Xynthadrug

Enrolled subjects will be treated with intravenous infusions of Xyntha for: • On-Demand treatment, • Surgical Prophylaxis at a dose and frequency prescribed by the subject's treating physician in accordance with the Xyntha label and will be adjusted solely according to medical and therapeutic necessity.