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:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT03427060
Eligibility Criteria:
Inclusion Criteria:
1. Patients with known PNH.
2. Aged 18 and above. No upper age limit.
3. Lactate dehydrogenase (LDH) ≥1.5 upper limit of normal.
4. Must agree to use two methods of contraception that are ≥99% effective in preventing pregnancy.
5. Resistance to eculizumab (Soliris®).
6. Voluntary written informed consent.
7. Willing to self-inject Coversin daily.
8. Willing to receive appropriate prophylaxis against Neisseria infection.
9. Willing to avoid prohibited medications for duration of study.
Exclusion Criteria:
1. Subjects with body weight \<50 kg (110 lb) or \>100 kg (220 lb).
2. Pregnancy or breast feeding (females).
3. Known allergy to ticks or severe reaction to arthropod venom (e.g. bee or wasp venom).
4. Unresolved Neisseria meningitidis infection.
5. Patients who have not received adequate immunization against Neisseria meningitides.
6. Impaired hepatic function.
7. Patients with impaired renal function.
8. Failure to satisfy the Principal Investigator (PI) of fitness to participate for any other reason.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03427060
Study Brief:
Protocol Section:
NCT03427060