← Back to Search

Long-Term Voxelotor for Sickle Cell Disease (034OLE Trial)

Phase 3

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up five years

Awards & highlights

034OLE Trial Summary

This trial is for people with sickle cell disease who have already participated in other voxelotor clinical trials.

Who is the study for?

This trial is for people with Sickle Cell Disease who were in a previous Voxelotor study but stopped due to side effects that are no longer risky. Women must test negative for pregnancy and use birth control, and men must use barrier contraception after the last dose.Check my eligibility

What is being tested?

The study tests long-term effects of Voxelotor on participants from an earlier trial. It's an open-label extension, meaning everyone knows they're getting Voxelotor and there's no placebo group.See study design

What are the potential side effects?

Specific side effects aren't listed here, but since it's a continuation for those previously affected by manageable adverse events (AEs), similar side effects may occur.

034OLE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ five years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~five years

This trial's timeline: 3 weeks for screening, Varies for treatment, and five years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Frequency of sickle cell-related complications

Number of participants with treatment-related adverse events as assessed by CTCAE v4.03

Secondary outcome measures

Response in Hemolytic Anemia

Side effects data

From 2022 Phase 4 trial • 25 Patients • NCT04400487

32%

Sickle cell anaemia with crisis

Acute chest syndrome

100%

80%

60%

40%

20%

Study treatment Arm

Voxelotor: SCD Related

Voxelotor: Non-SCD Related

034OLE Trial Design

1Treatment groups

Experimental Treatment

Group I: VoxelotorExperimental Treatment1 Intervention

Participants will receive voxelotor (GBT440) at the highest dose (either 900 mg or 1500 mg) deemed safe by the Data Safety Monitoring Board (DSMB).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Voxelotor

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Global Blood TherapeuticsLead Sponsor

35 Previous Clinical Trials

4,698 Total Patients Enrolled

PfizerLead Sponsor

4,567 Previous Clinical Trials

10,911,695 Total Patients Enrolled

Mark DavisStudy DirectorGlobal Blood Therapeutics

Media Library

Voxelotor Clinical Trial Eligibility Overview. Trial Name: NCT03573882 — Phase 3

Sickle Cell Disease Research Study Groups: Voxelotor

Sickle Cell Disease Clinical Trial 2023: Voxelotor Highlights & Side Effects. Trial Name: NCT03573882 — Phase 3

Voxelotor 2023 Treatment Timeline for Medical Study. Trial Name: NCT03573882 — Phase 3

Frequently Asked Questions

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

Can you please share what prior research has been conducted on this therapy?

"This treatment was first trialed at the Royal London Hospital in 2016. 11 clinical trials have completed since then, with 7 more active studies currently underway--many of which are based out of Richmond, Virginia."

Answered by AI

Is this a clinical trial that is testing an innovative new treatment?

"Currently, there are 7 ongoing clinical trials related to this treatment being conducted in 39 cities and 14 countries. The first trial was completed in 2016 by 155 patients and Global Blood Therapeutics. In the 5 years since then, 11 more studies have been carried out."

Answered by AI

How many volunteers are participating in this trial?

"Unfortunately, this trial is not looking for new patients at the moment. It was posted on June 6th 2018 and edited September 28th 2022. However, if you are still seeking medical trials, there are 7 other options for this treatment and 201 clinical trials actively admitting participants with anemia and sickle cell."

Answered by AI

Is this clinical trial well represented in Canadian medical clinics?

"This study is being conducted at 25 different hospitals, with participating locations in cities such as Richmond, Pittsburgh and Philadelphia. It may be helpful for patients enrolling to choose the nearest location in order to limit travel requirements."

Answered by AI

Could you please elaborate on the risks associated with this treatment?

"This treatment received a score of 3 for safety because it is a Phase 3 trial. This means that there is already some data supporting the efficacy of the medication and multiple rounds of data confirming its safety."

Answered by AI

Is this experiment still looking for new participants?

"Although this study is not recruiting patients at the moment, it was last updated on September 28th, 2022. According to clinicaltrials.gov, there are 208 other trials that might be of interest and are currently enrolling participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Assess the Effect of Long-term Treatment With Voxelotor in Participants Who Have Completed Treatment in Study GBT440-031

2018. "Study to Assess the Effect of Long-term Treatment With Voxelotor in Participants Who Have Completed Treatment in Study GBT440-031". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03573882.

All > Sickle Cell Anemia