Long-term Safety, Curvature Deformity Characterization, and Immunogenicity Over Time in Subjects Previously Treated With AA4500 for Peyronies Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02298829|
Recruitment Status : Completed
First Posted : November 24, 2014
Last Update Posted : June 20, 2018
|Condition or disease||Intervention/treatment|
|Peyronie's Disease||Drug: Subjects Previously Treated with AA4500|
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 and AUX-II and neutralizing antibodies to AUX-I and AUX-II will be collected at each long-term follow-up visit.
At each long-term follow-up visit, a flaccid penile examination will be performed and a curvature deformity measurement (with the penis in the erect state) will be recorded. Subjects will also be asked to complete the Peyronie's Disease Questionnaire (PDQ) and the International Index of Erectile Function (IIEF) questionnaire. At each visit, medical, surgical, or other treatments for Peyronie's disease since the last assessment will also be collected and recorded.
|Study Type :||Observational|
|Actual Enrollment :||184 participants|
|Official Title:||Long-term Safety, Curvature Deformity Characterization, and Immunogenicity Over Time in Subjects Previously Treated With AA4500 for Peyronies Disease in Studies AUX-CC-802, AUX-CC-803, AUX-CC-804 and AUX-CC-806|
|Study Start Date :||November 2014|
|Actual Primary Completion Date :||April 9, 2018|
|Actual Study Completion Date :||April 9, 2018|
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.
Drug: Subjects Previously Treated with AA4500
no treatment to be administered - observational only
- To assess the long-term safety of AA4500 in adult men with Peyronies disease [ Time Frame: 5 years post treatment ]
- To characterize curvature deformity over time in adult men with Peyronies disease who were treated with AA4500 [ Time Frame: 5 years post treatment ]
- To assess the long-term immunogenicity profile of AA4500 in adult men with Peyronies disease [ Time Frame: 5 years post treatment ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02298829