Status:
COMPLETED
Long-term Safety, Curvature Deformity Characterization, and Immunogenicity Over Time in Subjects Previously Treated With AA4500 for Peyronies Disease
Lead Sponsor:
Endo Pharmaceuticals
Conditions:
Peyronie's Disease
Eligibility:
MALE
18-90 years
Brief 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 ...
Detailed Description
At each long-term follow-up visit, subjects will be assessed for adverse events relative to their previous long-term follow-up assessment. Blood samples for the determination of antibodies to AUX-I an...
Eligibility Criteria
Inclusion
- 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).
- Be able and willing to comply with the follow-up assessments outlined in the protocol, as determined by the investigator.
- Voluntarily sign and date an informed consent agreement approved by the Institutional Review Board/Independent Ethics Committee (IRB/IEC).
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Exclusion
- None
- \-
Key Trial Info
Start Date :
November 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 9 2018
Estimated Enrollment :
184 Patients enrolled
Trial Details
Trial ID
NCT02298829
Start Date
November 1 2014
End Date
April 9 2018
Last Update
June 20 2018
Active Locations (30)
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1
Alaska Clinical Research Center, LLC
Anchorage, Alaska, United States, 99503
2
Urology Assoc Medical Group
Burbank, California, United States, 91505
3
South Orange County Med Research Center
Laguna Hills, California, United States, 92653
4
San Diego Sexual Medicine
San Diego, California, United States, 92120