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APL-2 LONG-TERM SAFETY AND EFFICACY EXTENSION STUDY

Not Applicable
Conditions
-D595 Paroxysmal nocturnal haemoglobinuria [Marchiafava-Micheli]
Paroxysmal nocturnal haemoglobinuria [Marchiafava-Micheli]
D595
Registration Number
PER-037-20
Lead Sponsor
Apellis Pharmaceuticals Inc.,
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1.Subjects with PNH who have participated in an APL-2 clinical trial. Subjects who received treatment with APL-2
must have experienced clinical benefit in the opinion of the Investigator.

2.Willing and able to give written informed consent

3.Women of child-bearing potential (WOCBP) must have a negative pregnancy test and must agree to continue to use an approved method of contraception for the duration of the study and 60 days after their last dose of study drug.

4.Males must agree to continue to use an approved method of contraception and must agree to refrain from donating sperm for the duration of the study and 60 days after their last dose of study drug.

Exclusion Criteria

1.Subjects who have withdrawn from an APL-2 clinical study.

2.Any condition that could increase the subject’s risk by participating in the study.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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