CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 135 enrolled
Drug / intervention
ADYNOVATEbiological
Likely dose
ADYNOVATE (Antihemophilic Factor, Recombinant, PEGylated) — specific dose individualized by treating physicianAI-extracted
Key inclusion· 1
  • Hemophilia A patients receiving ADYNOVATE treatment
Key exclusion· 1
  • Patients not receiving ADYNOVATE

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

Search/NCT03169972
NCT03169972N/ACompleted

ADYNOVATE Drug Use-Results Survey

Takeda·observational·Posted May 30, 2017·Updated Feb 4, 2025

In Brief

An observational study evaluating ADYNOVATE for Hemophilia A. Completed, enrolled 135 participants across 52 sites.

Detailed Summary

The purpose of this survey is to understand the following items in the actual clinical use of ADYNOVATE in patients: 1. Unexpected adverse drug reactions 2. Occurrence of adverse drug reactions in the actual clinical use 3. Factors that may affect safety and efficacy 4. Occurrence of Factor VIII inhibitor development in patients with coagulation factor VIII deficiency (hereinafter hemophilia A) 5. Safety and efficacy for hemophilia A patients who received routine prophylactic therapy and on-demand therapy

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsHemophilia A
CountriesJapan
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedMay 30, 2017
Enrollment StartFeb 1, 2017
Primary CompletionSep 15, 2023
TodayJul 2, 2026
Enrollment to primary: 6.6 yearsPosted 9.1 years ago

Interventions

ADYNOVATEbiological

Antihemophilic Factor (Recombinant), PEGylated