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 @ 7:51 PM
Ignite Modification Date:
2025-12-24 @ 7:51 PM
NCT ID:
NCT01632904
Eligibility Criteria:
Inclusion Criteria:
* Subjects must currently be reporting symptoms while on a stable dose of HU monotherapy and be eligible to continue HU on study after randomization.
* Before screening, the subject must have been receiving HU for at least 12 weeks AND be receiving a stable dose.
* Subjects must meet baseline symptom criteria
* Subjects should meet at least 1 of the following criteria:
* No more than 2 phlebotomies within the 6 months before screening OR
* No palpable splenomegaly.
* Subjects must have a hematocrit that can be controlled within 35% to 48% (inclusive) before randomization.
Exclusion Criteria:
* Subjects with inadequate liver or renal function at screening.
* Subjects with clinically significant infection that requires therapy
* Subjects with known active hepatitis A, B, or C at screening or with known HIV positivity.
* Subjects with an active malignancy over the previous 2 years
* Subjects with clinically significant cardiac disease (Class III or IV).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01632904
Study Brief:
Protocol Section:
NCT01632904