Hemoglobin Modulator

Voxelotor for Lung Disease

Duke University Health System, Durham, NC
Targeting 2 different conditionsVoxelotorPhase 2RecruitingLed by Ian WelsbyResearch Sponsored by Duke University

Study 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
  • End Stage Lung Disease
  • Acute Lung Injury

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow ups ~ baseline to 2 days after initiation of voxelotor treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 2 days after initiation of voxelotor treatment for reporting.

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
2020
Completed Phase 4
~40

Find a site

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,275 Previous Clinical Trials
3,092,270 Total Patients Enrolled
Ian WelsbyPrincipal Investigator
Duke University

Media Library

Voxelotor (Hemoglobin Modulator) Clinical Trial Eligibility Overview. Trial Name: NCT05289570 — Phase 2
Lung Disease Research Study Groups: Voxelotor Arm
Lung Disease Clinical Trial 2023: Voxelotor Highlights & Side Effects. Trial Name: NCT05289570 — Phase 2
Voxelotor (Hemoglobin Modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05289570 — Phase 2

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
Recent research and studies
clinicaltrials.govStudy
Voxelotor for Improving Oxygen Saturation in Adults
Ian Welsby, MD 2022. "Voxelotor for Improving Oxygen Saturation in Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05289570.
~7 spots leftby Jun 2024
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