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AB1 for Sickle Cell Disease ((SCD) Trial)
Phase 1 & 2
Recruiting
Led By Nirmish Shah, MD
Research Sponsored by Nirmish Shah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18 to 45 years of age, inclusive at screening
Confirmed SS or S-b0-thalassemia SCD
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the time of consent up to 12 months
Awards & highlights
(SCD) Trial Summary
This trial is testing a new drug by giving increasing doses to groups of patients to see what effects it has. The drug is taken orally once a day for 8 weeks.
Who is the study for?
Adults aged 18-45 with Sickle Cell Disease (SCD), specifically SS or S-b0-thalassemia, who have had 2-10 sickle crises in the past year but none in the last month. Participants must not be pregnant, agree to contraception use, and should have a history of following medical care. They can't join if they have severe kidney issues, abnormal blood counts, certain heart conditions, recent drug abuse, or are on specific other treatments.Check my eligibility
What is being tested?
The trial is testing AB1 at increasing doses from 2mg to 32mg taken orally once daily for eight weeks. It's an open-label study where everyone knows what treatment they're getting and it aims to find out how much of the drug can be given safely.See study design
What are the potential side effects?
Potential side effects aren't specified here but generally could include typical reactions to new medications such as digestive discomfort, headaches, possible allergic reactions or changes in blood counts due to the nature of SCD.
(SCD) Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 45 years old.
Select...
I have been diagnosed with SS or Sβ0-thalassemia sickle cell disease.
Select...
I've had 2-10 sickle cell crises in the last year, but none in the past month.
(SCD) Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the time of consent up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the time of consent up to 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of adverse events/serious adverse events as measured by patient report/medical records
Number of ≥Grade 2 study related adverse events as measured by patient report/medical record
Secondary outcome measures
Change in AUC o-t as measured by blood test
Change in CL as measured by blood test
Change in Cmax as measured by blood test
+8 more(SCD) Trial Design
1Treatment groups
Experimental Treatment
Group I: AB1Experimental Treatment1 Intervention
AB1 is the investigational product in this study taken orally, once daily, for 8 weeks. This will be an open-label, dose escalating study with a starting dose of 2mg. Up to 6 additional cohorts will be enrolled at subsequently higher doses of 4mg, 8mg, 10 mg, 12 mg, 16mg, and 32mg.
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Who is running the clinical trial?
Nirmish ShahLead Sponsor
1 Previous Clinical Trials
16 Total Patients Enrolled
Nirmish Shah, MDPrincipal InvestigatorDuke University
5 Previous Clinical Trials
137 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken any experimental drugs in the last 28 days.I do not have any planned surgeries or major procedures during the study.I haven't had any severe sickle cell complications in the last 28 days.I have had severe sepsis or septic shock in the last 3 months.I am between 18 and 45 years old.I have been diagnosed with SS or Sβ0-thalassemia sickle cell disease.My heart condition severely limits my physical activity.I am on medication for seizures or altered mental status.I am not willing or able to follow the birth control requirements of the study.I have another cancer diagnosis such as MDS, leukemia, or an abnormal karyotype.I have consistently followed all treatments and care plans.I stopped taking Oxbryta 30 days ago or Adakveo 3 months ago, with no plans to restart.I've had 2-10 sickle cell crises in the last year, but none in the past month.I do not have a severe illness that could cause death within 6 months.My kidney function is severely impaired.I am a man and cannot follow the study's birth control rules.I need considerable assistance and am unable to carry out any work activities.I am on regular blood transfusions that cannot be stopped for medical reasons.I have not had a blood transfusion in the last 28 days.You have a history of using illegal drugs or drinking alcohol excessively in the past year.I have not had a fever or flu-like symptoms in the last week.
Research Study Groups:
This trial has the following groups:- Group 1: AB1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could I possibly qualify to join this clinical trial?
"The key inclusion criteria for this study are anemia, sickle cell, and being between 18-45 years old. Up to 30 patients can be enrolled in total."
Answered by AI
Does this research require that study participants be above the age of 18?
"Adults between the ages of 18-45 who meet the other specified inclusion criteria can enroll in this trial. There are 133 clinical trials for individuals under 18 and 85 for seniors aged 65 or older."
Answered by AI
Are new volunteers needed for this clinical trial?
"The clinical trial, which was last updated on October 6th, is not currently looking for candidates. This may be due to the fact that it was only posted less than a month ago on November 1st. Although this study isn't recruiting patients right now, there are 202 other studies that are."
Answered by AI
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