Clinical trial NCT02298829: Long-term Safety, Curvature Deformity Characterization, and Immunogenicity Over Time in Subjects Previously Treated With AA4500 for Peyronies Disease
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peyronie's Disease
Keywords: curvature
bend
Lead sponsor: Endo Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2014-11-24
Enrollment: 184
Sex: MALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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).

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

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 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.

Eligibility 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).

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   Exclusion Criteria:

   None

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Primary outcomes:
measure: To assess the long-term safety of AA4500 in adult men with Peyronies disease
timeFrame: 5 years post treatment
Secondary outcomes:
measure: To characterize curvature deformity over time in adult men with Peyronies disease who were treated with AA4500
timeFrame: 5 years post treatment
Other outcomes:
measure: To assess the long-term immunogenicity profile of AA4500 in adult men with Peyronies disease
timeFrame: 5 years post treatment
Locations:
city: Anchorage
country: United States
facility: Alaska Clinical Research Center, LLC
state: Alaska
city: Burbank
country: United States
facility: Urology Assoc Medical Group
state: California
city: Laguna Hills
country: United States
facility: South Orange County Med Research Center
state: California
city: San Diego
country: United States
facility: San Diego Sexual Medicine
state: California
city: Denver
country: United States
facility: The Urology Center of Colorado
state: Colorado
city: Aventura
country: United States
facility: South Florida Medical Research
state: Florida
city: Orlando
country: United States
facility: Florida Urology Associates
state: Florida
city: Wellington
country: United States
facility: Georgis Patsias, M.D., PA
state: Florida
city: Meridian
country: United States
facility: Idaho Urologic Institute
state: Idaho
city: Chicago
country: United States
facility: Uropartners, LLC
state: Illinois
city: Winfield
country: United States
facility: Dupage Medical Group
state: Illinois
city: Avon
country: United States
facility: Urology of Indiana LLC
state: Indiana
city: Jefferson
country: United States
facility: Metropolitan Urology P.S.C
state: Indiana
city: Overland Park
country: United States
facility: Kansas City Urology Care, PA
state: Kansas
city: Glen Burnie
country: United States
facility: Chesapeake Urology Research Associates
state: Maryland
city: Towson
country: United States
facility: Chesapeake Urology Research Associates
state: Maryland
city: Chestnut Hill
country: United States
facility: Men's Health Boston
state: Massachusetts
city: Hackensack
country: United States
facility: Center for Male Reproductive Medicine
state: New Jersey
city: Lawrenceville
country: United States
facility: Premier Urology Assoc LLC dba AdvanceMed Research
state: New Jersey
city: Albany
country: United States
facility: Community Care Physicians, PC
state: New York
city: Great Neck
country: United States
facility: Bruce R. Gilbert, MD, PhD, PC
state: New York
city: New York
country: United States
facility: Manhattan Medical Research Practice PLLC
state: New York
city: Purchase
country: United States
facility: Michael A. Werner, MD PC
state: New York
city: Raleigh
country: United States
facility: Associated Urologists of North Carolina
state: North Carolina
city: Cincinnati
country: United States
facility: Tristate Urologic Services dba TUG Research
state: Ohio
city: Bala-Cynwyd
country: United States
facility: Urologic Consultants of SE PA
state: Pennsylvania
city: Dallas
country: United States
facility: Urology Clinics of North Texas, PA
state: Texas
city: Salt Lake City
country: United States
facility: Jean Brown Research
state: Utah
city: Richmond
country: United States
facility: Virginia Urology
state: Virginia
city: Virginia Beach
country: United States
facility: Urology of Virginia, PLLC
state: Virginia
Study officials:
References: