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A Study of Adynovate in Previously Treated Chinese Teenagers and Adults With Severe Hemophilia A

NCT05707351 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2025-05-01

Study results available
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Summary

The main aim of the study is to determine how well Adynovate works to decrease bleeding in previously treated Chinese men and boys with severe hemophilia A when given prophylactically.

Participants will be treated with Adynovate twice a week for 26 weeks or until participants have received 50 days of treatment with Adynovate (whichever takes longer). Participants will need to visit their study clinic several times during their participation.

Conditions

Interventions

BIOLOGICAL

Adynovate

Adynovate was injected intravenously using an appropriately sized syringe as a bolus infusion over a period of less than or equal to (\<=) 5 minutes (maximum infusion rate, 10 milliliters per minute \[mL/min\]).

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Takeda

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-27
Primary Completion
2024-09-05
Completion
2024-09-05

Countries

  • China

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05707351 on ClinicalTrials.gov