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

Peyronie's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02298829
• Other study ID #: AUX-CC-810
• Status: Completed
• Start date: November 2014
• Est. completion date: April 9, 2018

Study information

• Verified date: June 2018
• Source: Endo Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: April 9, 2018
• Est. primary completion date: April 9, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 90 Years

Eligibility

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:

Related Conditions & MeSH terms

• Penile Induration
• Peyronie's Disease

Intervention

Drug:
• Subjects Previously Treated with AA4500
no treatment to be administered - observational only

Locations

Country	Name	City	State
United States	Community Care Physicians, PC	Albany	New York
United States	Alaska Clinical Research Center, LLC	Anchorage	Alaska
United States	South Florida Medical Research	Aventura	Florida
United States	Urology of Indiana LLC	Avon	Indiana
United States	Urologic Consultants of SE PA	Bala-Cynwyd	Pennsylvania
United States	Urology Assoc Medical Group	Burbank	California
United States	Men's Health Boston	Chestnut Hill	Massachusetts
United States	Uropartners, LLC	Chicago	Illinois
United States	Tristate Urologic Services dba TUG Research	Cincinnati	Ohio
United States	Urology Clinics of North Texas, PA	Dallas	Texas
United States	The Urology Center of Colorado	Denver	Colorado
United States	Chesapeake Urology Research Associates	Glen Burnie	Maryland
United States	Bruce R. Gilbert, MD, PhD, PC	Great Neck	New York
United States	Center for Male Reproductive Medicine	Hackensack	New Jersey
United States	Metropolitan Urology P.S.C	Jefferson	Indiana
United States	South Orange County Med Research Center	Laguna Hills	California
United States	Premier Urology Assoc LLC dba AdvanceMed Research	Lawrenceville	New Jersey
United States	Idaho Urologic Institute	Meridian	Idaho
United States	Manhattan Medical Research Practice PLLC	New York	New York
United States	Florida Urology Associates	Orlando	Florida
United States	Kansas City Urology Care, PA	Overland Park	Kansas
United States	Michael A. Werner, MD PC	Purchase	New York
United States	Associated Urologists of North Carolina	Raleigh	North Carolina
United States	Virginia Urology	Richmond	Virginia
United States	Jean Brown Research	Salt Lake City	Utah
United States	San Diego Sexual Medicine	San Diego	California
United States	Chesapeake Urology Research Associates	Towson	Maryland
United States	Urology of Virginia, PLLC	Virginia Beach	Virginia
United States	Georgis Patsias, M.D., PA	Wellington	Florida
United States	Dupage Medical Group	Winfield	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Endo Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To assess the long-term immunogenicity profile of AA4500 in adult men with Peyronies disease		5 years post treatment
Primary	To assess the long-term safety of AA4500 in adult men with Peyronies disease		5 years post treatment
Secondary	To characterize curvature deformity over time in adult men with Peyronies disease who were treated with AA4500		5 years post treatment