Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:27 PM
Ignite Modification Date:
2025-12-24 @ 6:27 PM
NCT ID:
NCT01054768
Eligibility Criteria:
Inclusion Criteria:
* Proven diagnosis of sickle cell disease, either homozygous sickle disease or Hb S Beta zero thalassemia genotype
* Age at entry at least 14 years. Younger children will not be included since the combination alpha-lipoic acid and acetyl-L-carnitine tablets are not available in a smaller dose at this time.
Exclusion Criteria:
* More than 3 packed red blood transfusions in the past 12 months
* Coexisting illness that could contribute to inflammation. These include chronic hepatitis, lupus, arthritis, inflammatory bowel disease, chronic osteomyelitis, and other similar conditions.
* Acute sickle cell disease related symptoms requiring a hospital visit in the past 4 weeks
* Women who are pregnant, attempting to get pregnant, or breast feeding
* Active participation in other investigational drug or device studies
* Participants who start hydroxyurea or regular transfusion therapy during the course of the study on the recommendation of their primary hematologist will be ineligible for further participation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Study:
NCT01054768
Study Brief:
Protocol Section:
NCT01054768