Ignite Creation Date:
2025-12-25 @ 3:36 AM
Ignite Modification Date:
2025-12-26 @ 2:20 AM
Study NCT ID:
NCT05407805
Status:
COMPLETED
Last Update Posted:
2024-07-16
First Post:
2022-05-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Learn About Sickle Cell Disease In Adult Patients
Sponsor:
Pfizer
Organization:
Study Overview
Official Title:
A LOW-INTERVENTIONAL LONGITUDINAL STUDY OF AN ELECTRONIC SICKLE CELL DISEASE PATIENT REPORTED OUTCOMES IN ADULT PARTICIPANTS AGED ≥18 YEARS OF AGE ON AND OFF HYDROXYUREA
Status:
COMPLETED
Status Verified Date:
2024-07
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:
The purpose of this clinical trial is to evaluate the performance of the sickle cell disease (SCD) electronic diary in people with SCD who are on treatment that will change SCD and those not on such a treatment.
SCD is a type of condition when there are fewer red blood cells to carry oxygen around the body.
This disease can be passed on from parent to child and may cause pain, infections and damage to organs.
This study is seeking participants who:
* are confirmed with SCD
* are on a stable regimen of disease changing treatment or have not received any disease changing treatment before the start of the study and do not plan any changes in their treatment during the 6-month study observation period For 6 months, participants will be asked to complete a daily electronic diary to report on their experience in the past 24 hours with sickle cell pain crisis (if they got any treatment and what medications they took), worst pain, worst tiredness, and their ability to perform usual physical activities. We will compare the experiences of people who are taking SCD-modifying therapy to those that are not taking a SCD-modifying therapy.
SCD is a type of condition when there are fewer red blood cells to carry oxygen around the body.
This disease can be passed on from parent to child and may cause pain, infections and damage to organs.
This study is seeking participants who:
* are confirmed with SCD
* are on a stable regimen of disease changing treatment or have not received any disease changing treatment before the start of the study and do not plan any changes in their treatment during the 6-month study observation period For 6 months, participants will be asked to complete a daily electronic diary to report on their experience in the past 24 hours with sickle cell pain crisis (if they got any treatment and what medications they took), worst pain, worst tiredness, and their ability to perform usual physical activities. We will compare the experiences of people who are taking SCD-modifying therapy to those that are not taking a SCD-modifying therapy.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: