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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants with SCD ages 12 to 65 years, inclusive
Male or female with SCD
Must not have
Female participant who is breastfeeding or pregnant
Participants who had more than 10 VOC within 12 months of screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through week 48
Summary
This trial is testing an oral medication called osivelotor to see if it can safely help people with sickle cell disease feel better. It will also study how the medication works in the body.
Who is the study for?
This trial is for individuals aged 12-65 with Sickle Cell Disease (SCD) who have had 2 to 10 pain episodes related to the disease in the past year. They must not be pregnant or breastfeeding, and should not need regular blood transfusions or have received one within the last 90 days.
What is being tested?
The study is testing GBT021601's safety and effectiveness in treating SCD. It will look at how the body processes the drug and its impact on health outcomes for both adults and children with stable hemoglobin levels.
What are the potential side effects?
While specific side effects of GBT021601 are not listed, common ones may include reactions at injection sites, potential liver issues, headaches, nausea, fatigue, and possible changes in blood counts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 12 and 65 years old and have sickle cell disease.
Select...
I have sickle cell disease.
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I've had 2 to 10 severe pain crises in the last year.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently pregnant or breastfeeding.
Select...
I have had more than 10 pain crises in the last year.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through week 48
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through week 48
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Part A
Part B
Part C
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Part CExperimental Treatment1 Intervention
100 mg dose in cohort C1, dose level for cohorts C2 to C4 to be determined based on emerging data
Group II: Part AActive Control1 Intervention
Initially, participants will be randomized 1:1 to 100 mg and 150 mg daily. Upon review of the 150 mg safety data from at least 6 participants, there will be 1:1:1 randomization: 100 mg, 150 mg, and up to 200 mg.
Participants will then receive maintenance once daily doses through Week 12.
Group III: Part BPlacebo Group1 Intervention
Following the selection of the optimal safe and effective dose from Part A of the study, Part B of the study will assess the efficacy and safety of 48 weeks of the optimal dose, compared to placebo
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Hydroxyurea is a cornerstone treatment for Sickle Cell Disease (SCD) that works by increasing the production of fetal hemoglobin (Hb F), which reduces the sickling of red blood cells and decreases vaso-occlusive events. This is crucial for SCD patients as it helps to prevent painful crises and other complications like acute chest syndrome.
Osivelotor, a hemoglobin modulator, functions by increasing hemoglobin levels and reducing hemolysis, thereby improving oxygen delivery and reducing the frequency of vaso-occlusive crises. These treatments are vital as they address the underlying pathophysiology of SCD, improving quality of life and reducing morbidity.
Pharmacological interventions for painful sickle cell vaso-occlusive crises in adults.
Pharmacological interventions for painful sickle cell vaso-occlusive crises in adults.
Find a Location
Who is running the clinical trial?
PfizerLead Sponsor
4,661 Previous Clinical Trials
17,844,560 Total Patients Enrolled
Global Blood TherapeuticsLead Sponsor
35 Previous Clinical Trials
3,491 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,546 Previous Clinical Trials
14,885,716 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 12 and 65 years old and have sickle cell disease.I am currently pregnant or breastfeeding.I have had more than 10 pain crises in the last year.I have sickle cell disease.I've had 2 to 10 severe pain crises in the last year.I regularly get or have had a red blood cell transfusion in the last 3 months.I have been on a stable dose of hydroxyurea and/or L-glutamine for at least 90 days.
Research Study Groups:
This trial has the following groups:- Group 1: Part B
- Group 2: Part C
- Group 3: Part A
Awards:
This trial has 0 awards, including: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.
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