Multi-center Extension Study to Evaluate the Long Term Safety and Efficacy of APL-2 in the Treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH)
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Hematology, Hematology |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/9/2018 |
| Start Date: | August 27, 2018 |
| End Date: | December 20, 2020 |
A Phase III, Open Label, Non-Randomized, Multi-Center Extension Study to Evaluate the Long Term Safety and Efficacy of APL-2 in the Treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH)
This is an Open Label, Non-Randomized, Multi-Center Extension Study for ongoing and planned
Phase IB, Phase II, and Phase III studies with APL-2 in subjects with PNH.
Phase IB, Phase II, and Phase III studies with APL-2 in subjects with PNH.
Inclusion Criteria:
1. Subjects with PNH who have participated in an APL-2 clinical trial, and 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 use protocol defined methods of contraception for the duration of the study
and 60 days after their last dose of study drug.
4. Males must agree to use protocol defined methods of contraception and 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 Subjects who have withdrawn from an APL-2 clinical study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
We found this trial at
3
sites
Click here to add this to my saved trials
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
Click here to add this to my saved trials
University of Southern California The University of Southern California is one of the world’s leading...
Click here to add this to my saved trials