Long-term Safety, Curvature Deformity Characterization, and Immunogenicity Over Time in Subjects Previously Treated With AA4500 for Peyronies Disease
1 other identifier
observational
184
1 country
30
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 (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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2014
Typical duration for all trials
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 20, 2014
CompletedFirst Posted
Study publicly available on registry
November 24, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 9, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 9, 2018
CompletedJune 20, 2018
June 1, 2018
3.4 years
November 20, 2014
June 19, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess the long-term safety of AA4500 in adult men with Peyronies disease
5 years post treatment
Secondary Outcomes (1)
To characterize curvature deformity over time in adult men with Peyronies disease who were treated with AA4500
5 years post treatment
Other Outcomes (1)
To assess the long-term immunogenicity profile of AA4500 in adult men with Peyronies disease
5 years post treatment
Study Arms (1)
No Treatment
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.
Interventions
no treatment to be administered - observational only
Eligibility Criteria
Up to 750 subjects who received 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).
You may qualify if:
- 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).
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Alaska Clinical Research Center, LLC
Anchorage, Alaska, 99503, United States
Urology Assoc Medical Group
Burbank, California, 91505, United States
South Orange County Med Research Center
Laguna Hills, California, 92653, United States
San Diego Sexual Medicine
San Diego, California, 92120, United States
The Urology Center of Colorado
Denver, Colorado, 80211, United States
South Florida Medical Research
Aventura, Florida, 33180, United States
Florida Urology Associates
Orlando, Florida, 32803, United States
Georgis Patsias, M.D., PA
Wellington, Florida, 33449, United States
Idaho Urologic Institute
Meridian, Idaho, 83642, United States
Uropartners, LLC
Chicago, Illinois, 60612, United States
Dupage Medical Group
Winfield, Illinois, 60190, United States
Urology of Indiana LLC
Avon, Indiana, 46123, United States
Metropolitan Urology P.S.C
Jefferson, Indiana, 47130, United States
Kansas City Urology Care, PA
Overland Park, Kansas, 66211, United States
Chesapeake Urology Research Associates
Glen Burnie, Maryland, 21061, United States
Chesapeake Urology Research Associates
Towson, Maryland, 21204, United States
Men's Health Boston
Chestnut Hill, Massachusetts, 02467, United States
Center for Male Reproductive Medicine
Hackensack, New Jersey, 07601, United States
Premier Urology Assoc LLC dba AdvanceMed Research
Lawrenceville, New Jersey, 08648, United States
Community Care Physicians, PC
Albany, New York, 12208, United States
Bruce R. Gilbert, MD, PhD, PC
Great Neck, New York, 11021, United States
Manhattan Medical Research Practice PLLC
New York, New York, 10016, United States
Michael A. Werner, MD PC
Purchase, New York, 10577, United States
Associated Urologists of North Carolina
Raleigh, North Carolina, 27612, United States
Tristate Urologic Services dba TUG Research
Cincinnati, Ohio, 45212, United States
Urologic Consultants of SE PA
Bala-Cynwyd, Pennsylvania, 19004, United States
Urology Clinics of North Texas, PA
Dallas, Texas, 75231, United States
Jean Brown Research
Salt Lake City, Utah, 84124, United States
Virginia Urology
Richmond, Virginia, 23235, United States
Urology of Virginia, PLLC
Virginia Beach, Virginia, 23462, United States
Biospecimen
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.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2014
First Posted
November 24, 2014
Study Start
November 1, 2014
Primary Completion
April 9, 2018
Study Completion
April 9, 2018
Last Updated
June 20, 2018
Record last verified: 2018-06