Viewing Study NCT05752565



Ignite Creation Date: 2024-05-06 @ 6:42 PM
Last Modification Date: 2024-10-26 @ 2:53 PM
Study NCT ID: NCT05752565
Status: COMPLETED
Last Update Posted: 2023-03-02
First Post: 2023-02-20

Brief Title: Physical Activity and FVIII Elimination Relevance to Personalized Therapy in Severe Hemophilia A
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study Overview

Official Title: Physical Activity and FVIII Elimination Relevance to Personalized Therapy in Severe Hemophilia A
Status: COMPLETED
Status Verified Date: 2023-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: In persons with severe haemophilia A infused factor VIII half-life and other pharmacokinetic can vary according to determinants such as blood group von Willebrand factor VWF level or age However FVIII pharmacokinetics PK has not been throughly studied in patients with severe HA as a function of daily physical activity It si known that vigorous intensity physical activityexercise can transiently but significantly increase circulating levels of endogenous VWF and consequently FVIII in normal subjects and in patients with moderate or mild haemophilia A The proposed study is a Proof of Concept one as it will be aimed at investigating the relation between daily physical activity measured by Sensewear armband device as number of daily steps and PK variability of infused rec-FVIII concentrate This kind of investigation has never been done and it is a great interest also for the evaluation of patients qualitiy of life
Detailed Description: In persons with severe haemophilia A infused factor VIII half-life and other pharmacokinetic can vary according to determinants such as blood group von Willebrand factor VWF level or age However FVIII pharmacokinetics PK has not been throughly studied in patients with severe HA as a function of daily physical activity It si known that vigorous intensity physical activityexercise can transiently but significantly increase circulating levels of endogenous VWF and consequently FVIII in normal subjects and in patients with moderate or mild haemophilia A The proposed study is a Proof of Concept one as it will be aimed at investigating the relation between daily physical activity measured by Sensewear armband device as number of daily steps and PK variability of infused rec-FVIII concentrate This kind of investigation has never been done and it is a great interest also for the evaluation of patients qualitiy of life Physical Examinations at screening and subsequent study visits a physical examination will be performed on the following body systems being described as normal or abnormal general appearance headand neck eyes and ears nose and throat heart abdomen extremities and joints lymph nodes and neurological At screening if an abnormal condition is detected the condition will be described on the medical history CRF At study visit if a new abnormal or worsened abnormal pre-existing condition is detected the condition will be described n the CRF

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: True
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: True
Is an FDA AA801 Violation?: None