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 @ 11:39 PM
Ignite Modification Date:
2025-12-24 @ 11:39 PM
NCT ID:
NCT03337451
Eligibility Criteria:
Inclusion Criteria:
* Completion of the OPN-305-106 study
* Principal Investigator adjudicated efficacy response defined as either transfusion independence", "stable disease", "minor HI-E response" or "major HI-E response" and in the opinion of the Principal Investigator the patient may benefit from continued treatment with OPN-305 monotherapy or combination treatment with azacitidine.
* Provide written informed consent for the follow up protocol.
Exclusion Criteria:
* Refusal to provide written informed consent
* Withdrawal from the OPN-305-106 study prior to the final EOT visit
* Plan to be included into another interventional investigational study.
* Progression of disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03337451
Study Brief:
Protocol Section:
NCT03337451