CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 50 enrolled
Drug / intervention
ADVATEbiological
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/NCT04985682
NCT04985682Phase 4Completed
CompareCT.gov

Phase 4, Multicenter, Prospective, Interventional, Post-Marketing Study in Hemophilia A Patients in India Receiving ADVATE as On-Demand or Prophylaxis Under Standard Clinical Practice

Baxalta now part of Shire·interventional·Posted Aug 2, 2021·Updated Mar 7, 2024

In Brief

A Phase 4 clinical trial evaluating ADVATE for Hemophilia A. Completed, enrolled 50 participants across 5 sites.

Detailed Summary

The main aim of this study is to learn more about side effects of Advate when given as standard treatment to people with hemophilia A who have already been treated. The study sponsor will not be involved in how participants are treated but will provide instructions on how the clinics will record what happens during the study. Participants will need to visit the study doctor 5 times in total during the study. During these visits, study data will be collected by the study doctor.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemophilia A
CountriesIndia
CollaboratorsTakeda Development Center Americas, Inc.

Timeline

Phase 4CompletedFinished
20222023202420252026
First PostedAug 2, 2021
Enrollment StartJan 14, 2022
Primary CompletionFeb 10, 2023
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 4.9 years ago

Interventions

ADVATEbiological

Antihemophilic factor (AHF) activity expressed in international units (IU) per vial.