Discontinuation of Study Medication. In rare instances, it may be necessary for a patient to permanently discontinue (definitive discontinuation) the study medication. If study medication is permanently discontinued, the dose of the patient will be tapered as described in Section 7.2, and the patient will remain in the study for 30 days after last dose of ALXN2050 to be evaluated for AEs. A patient is free to withdraw from the study at any time without jeopardizing future medical care. In addition, the PI (or designee) may decide, for reasons of medical prudence or patient noncompliance or if C5 inhibitor is deemed necessary, to discontinue dosing of ALXN2050 for an individual patient. The Sponsor’s Medical Monitor will be notified immediately, and if possible, before dosing is terminated. Reasons for patient withdrawal include: • Intercurrent illness that would, in the judgment of the Investigator, affect assessment of clinical status to a significant degree • Unacceptable toxicity (including a clinically significant laboratory abnormality) necessitating discontinuation of study participation or that, in the judgment of the Investigator, compromises the ability to continue study-specific procedures, or it is considered not to be in the patient’s best interest to continue the study • Patient request to discontinue for any reason • Pregnancy or planned pregnancy • Patient noncompliance • Lack of efficacy • Development of seizures (see Section 10.6 Seizure Management Plan) • Discontinuation of the study at the request of the Sponsor, Regulatory Agency, Institutional Review Boards (IRB)/Independent Ethics Committees (IEC) • Any other condition or circumstance that that would jeopardize the welfare of the patient if s/he were to continue in the study • Participation in other clinical studies with investigational products during this study The reason for any patient’s discontinuation and the date of withdrawal will be recorded in the patient’s CRF. The patient’s CRF, which will be completed up to the point of withdrawal, will be retained for the Sponsor. If a patient discontinues from the study for any reason, all protocol procedures as defined in Table 1 for treatment Week 12 should be performed as an ET visit if the patient discontinues prior to Week 12. If the patient withdraws consent for disclosure of future information, the Sponsor may retain and continue to use any data collected before such a withdrawal of consent. If a patient withdraws from the study, he/she may request destruction of ...
