Overview

Long-term Safety, Curvature Deformity Characterization, and Immunogenicity Over Time in Subjects Previously Treated With AA4500 for Peyronies Disease

Status:
Completed

Trial end date:
2018-04-09

Target enrollment:
0

Participant gender:
Male

Summary

This a Phase 4 non-treatment, long-term follow-up study of subjects who received AA4500 in a 12-month double blind placebo-controlled study (AUX CC 803 or AUX-CC-804) or in a 9-month open label study (AUX-CC-802 or AUX-CC-806) sponsored by Auxilium Pharmaceuticals, Inc. After participation in one of the aforementioned studies, subjects will be followed yearly for up to 4 consecutive long-term follow-up visits with at least 6 months between consecutive visits

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Endo Pharmaceuticals

Criteria

Inclusion Criteria:

1. Have received at least one injection of AA4500 and completed at least the first or
last follow-up visit in one of the Auxilium-sponsored studies (AUX CC-802, AUX-CC-803,
AUX-CC-804, or AUX-CC-806).

2. Be able and willing to comply with the follow-up assessments outlined in the protocol,
as determined by the investigator.

3. Voluntarily sign and date an informed consent agreement approved by the Institutional
Review Board/Independent Ethics Committee (IRB/IEC).

-

Exclusion Criteria:

None

-