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Anti-metabolites
Hydroxyurea + EPO for Sickle Cell Disease (ACHiEvE-SCD Trial)
Phase 1 & 2
Waitlist Available
Led By Julia Z Xu, MD, MScGH
Research Sponsored by Julia Xu
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 12 weeks; baseline to 24 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial will test if erythropoietin (EPO) and hydroxyurea are safe and effective in treating anemia in patients with sickle cell disease.
Who is the study for?
Adults over 18 with confirmed sickle cell disease (HbSS or HbS/β0-thalassemia), not on blood transfusion programs, and without recent use of certain drugs like voxelotor or EPO. Participants must have been on a stable dose of hydroxyurea for at least 60 days and plan to continue it during the trial.
What is being tested?
The study is testing the combination of erythropoietin (EPO) with hydroxyurea to treat chronic anemia in sickle cell disease patients. It's a Phase 1/2 trial, meaning they're looking at safety and how well it works across multiple centers.
What are the potential side effects?
Possible side effects may include pain at injection site, headache, high blood pressure, joint pain, dizziness, and fever from EPO; while hydroxyurea can cause nausea, vomiting, loss of appetite, mouth sores, diarrhea or constipation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 12 weeks; baseline to 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 12 weeks; baseline to 24 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in hemoglobin (Hb) level
Secondary study objectives
Change in frequency of blood transfusions
Other study objectives
Changes in absolute reticulocyte count
Changes in cardiac index as assessed by echocardiography
Changes in complete blood count parameters
+8 moreSide effects data
From 2015 Phase 4 trial • 150 Patients • NCT0020264425%
Headache
24%
Palpitations
12%
Hypertension
8%
Diarrhoea
8%
Arthralgia
7%
Vertigo
7%
Asthenia
5%
Epistaxis
5%
Anaemia
5%
Chest pain
5%
Upper respiratory tract infection
5%
Urinary tract infection
4%
Ischaemic stroke
3%
Nasopharyngitis
3%
Pharyngitis
1%
Crohn's disease
1%
Respiratory distress
1%
Laryngitis
1%
Bladder cancer
1%
Sepsis
1%
Neurological decompensation
1%
Pulmonary embolism
1%
Vasculitis cerebral
1%
Tachycardia
1%
Aphasia
1%
Cerebral infarction
1%
Type 2 diabetes mellitus
1%
Adenoid cystic carcinoma
1%
Left ventricular failure
1%
Ovarian cyst
1%
Upper gastrointestinal haemorrhage
1%
Sudden death
1%
Ear infection
1%
Leukopenia
1%
Hypertensive crisis
1%
Peripheral artery thrombosis
1%
Iron deficiency anaemia
1%
Angina unstable
1%
Traumatic haematoma
1%
Hyperglycaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Anagrelide
Hydroxyurea
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: ErythropoietinExperimental Treatment2 Interventions
Subjects on a stable dose of hydroxyurea will be treated with increasing doses of subcutaneous erythropoietin (EPO) as tolerated for an initial 12 weeks, during which the main safety and efficacy endpoints (including the primary endpoint of hemoglobin response) will be assessed. Subjects may continue on treatment for an additional 12 weeks as clinically indicated, with assessment of additional endpoints at the end of the 24-week study period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Epoetin Alfa
2014
Completed Phase 4
~8240
Hydroxyurea
2006
Completed Phase 4
~3490
Find a Location
Who is running the clinical trial?
Julia XuLead Sponsor
Carnegie Mellon UniversityOTHER
77 Previous Clinical Trials
539,878 Total Patients Enrolled
American Society of HematologyOTHER
13 Previous Clinical Trials
21,008 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had very high blood pressure on two separate tests.I have had a blood clot in the last 6 months.I have not had a serious illness, infection, or pain crisis in the last 2 weeks.I have untreated iron deficiency or started/changed iron supplements in the last 30 days.I am 18 years old or older.I have taken voxelotor or EPO in the last 60 days.I am on hemodialysis for end-stage kidney disease.I have been on a consistent dose of hydroxyurea for the last 60 days and plan to continue.I have been diagnosed with sickle cell disease (SCD).I have been on a stable dose of L-glutamine or crizanlizumab for at least 60 days.I am part of a chronic transfusion program or will have an exchange transfusion during the study.I do not have unstable heart pain, uncontrolled seizures, or other active cancers.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Erythropoietin
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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