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Hemoglobin Modulator
Voxelotor for Lung Disease (Voxelotor Trial)
Phase 2
Waitlist Available
Led By Ian Welsby
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 2 days after initiation of voxelotor treatment
Awards & highlights
Voxelotor Trial Summary
This trial will study the effects of voxelotor on oxygen saturation levels in 20 patients with hypoxemia. The study will compare oxygen saturation levels before and after voxelotor use, both at rest and during exercise, in order to evaluate the efficacy of voxelotor in increasing oxygen saturation levels.
Eligible Conditions
- Lung Disease
- Acute Lung Injury
Voxelotor Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 2 days after initiation of voxelotor treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 2 days after initiation of voxelotor treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in S/F ratio from baseline to 2 days after initiation of voxelotor treatment
Secondary outcome measures
Change in S/F ratio from baseline to 5 days after initiation of voxelotor treatment
Side effects data
From 2022 Phase 4 trial • 25 Patients • NCT0440048732%
Sickle cell anaemia with crisis
4%
Acute chest syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Voxelotor: SCD Related
Voxelotor: Non-SCD Related
Voxelotor Trial Design
1Treatment groups
Experimental Treatment
Group I: Voxelotor ArmExperimental Treatment1 Intervention
500 mg of Voxelotor two times a day (for a total daily dose of 1000 mg per day) for 5 days. This dose may increase to a total maximum daily dose of 1500 mg (500 mg three times a day), if subject tolerates the initial dose as determined by study doctor.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Voxelotor
2023
Completed Phase 4
~90
Find a Location
Who is running the clinical trial?
Duke UniversityLead Sponsor
2,359 Previous Clinical Trials
3,420,219 Total Patients Enrolled
Ian WelsbyPrincipal InvestigatorDuke University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- It is not expected that you will live for more than 48 hours.You are currently taking Fluconazole or other strong medications that may interact with the study drug.You have had a blood clot in your lungs in the past.You have ongoing bleeding that requires receiving more than one unit of blood transfusion every day.You have severe heart failure that is already causing symptoms in your everyday life.You have a long-term muscle or nerve disease that requires the use of a breathing machine.You have experienced organ failure in a different part of your body.
Research Study Groups:
This trial has the following groups:- Group 1: Voxelotor Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What evidence exists for the safety of Voxelotor in humans?
"Voxelotor has evidence of safety, so it was scored 2 out of 3. However, no clinical data supports its efficacy yet."
Answered by AI
Does this trial currently accept new participants?
"As indicated on clinicaltrials.gov, this research is presently recruiting participants for the study. It was initially announced on May 3rd 2022 and last updated on August 25th of the same year."
Answered by AI
How many participants have joined this medical experiment thus far?
"Affirmative. Clinicaltrials.gov data indicates that this clinical trial is actively enrolling participants, with the original posting date of May 3rd 2022 and last update on August 25th 2022. This study requires 20 people to enrol from one medical facility."
Answered by AI
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