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Voxelotor for Sickle Cell Disease (ActIVe Trial)

Phase 4
Waitlist Available
Research Sponsored by Global Blood Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 22-24
Awards & highlights

ActIVe Trial Summary

This trial will test a new drug to see if it improves daily activity and sleep quality for people with sickle cell disease.

Eligible Conditions
  • Sickle Cell Disease
  • Sickle Cell Anemia

ActIVe Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 22-24
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 22-24 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 From Baseline in Light Physical Activity to Week 10-12
Change From Baseline in Light Physical Activity to Week 22-24
Change From Baseline in Mean Overnight Oxygen Saturation (SpO2 Percentage [%]) to Week 10-12
+17 more

Side effects data

From 2022 Phase 4 trial • 25 Patients • NCT04400487
32%
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

ActIVe Trial Design

1Treatment groups
Experimental Treatment
Group I: VoxelotorExperimental Treatment1 Intervention
Participants will receive voxelotor at 1500 mg
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?

Global Blood TherapeuticsLead Sponsor
35 Previous Clinical Trials
4,852 Total Patients Enrolled
PfizerLead Sponsor
4,567 Previous Clinical Trials
10,911,849 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,474 Previous Clinical Trials
8,093,017 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How beneficial is Voxelotor to long-term health outcomes?

"Due to its Phase 4 status, Voxelotor is considered safe and received a score of 3 on our safety scale."

Answered by AI

Is this clinical experiment still recruiting participants?

"Per the information hosted on clinicaltrials.gov, this research is not recruiting candidates at present. This study was initially posted to the platform in October of 2020 and last updated in April 2022; however, 205 other trials are actively enlisting participants currently."

Answered by AI

Has there been any other research regarding the utilization of Voxelotor?

"Currently, 7 trials are being conducted on Voxelotor - 3 of which are in the advanced Phase 3 stage. Although mostly concentrated around Atlanta, Georgia, 139 sites across America have been selected to host studies for this drug's efficacy and safety."

Answered by AI

Could you name the various healthcare facilities that are currently engaging with this trial in state?

"At present, the trial is running in 10 sites across the US. Participants can pick from locations such as New york, Houston and Bronx along with other nearby areas. It is recommended to choose a site close to you so that travelling costs are minimized if you decide to participate."

Answered by AI

Does this research encompass those aged 70 and above?

"Patients aged between 12 and 55 years old may be eligible to join this trial, while those younger than 12 or older than 65 have 137 and 89 trials respectively that they can partake in."

Answered by AI

Does this trial embody any new or unique approaches to treatment?

"Presently, Global Blood Therapeutics' drug Voxelotor is being trialled at 39 distinct locations across 14 countries. The first trial for this medication began in 2016 and enrolled 155 participants before progressing to Phase 2 approval. Since then, 11 additional trials have been successfully completed."

Answered by AI

Is enrollment in this clinical trial still open?

"Patients aged 12 to 55 who have been diagnosed with sickle cell anemia are eligible for inclusion in this clinical trial, of which 25 participants will be accepted."

Answered by AI

What is the upper limit for participants in this research project?

"This clinical trial is no longer taking on any new patients. It was initially posted in October 2020 and last updated April 2022. Individuals looking for other trials may be interested to know that there are 198 studies currently recruiting participants with sickle cell anemia, as well as 7 separate trials involving Voxelotor medication."

Answered by AI
~6 spots leftby Apr 2025