Peyronie's DiseaseNCT02298829
Long-term Safety, Curvature Deformity Characterization, and Immunogenicity Over Time in Subjects Previously Treated With AA4500 for Peyronies Disease
An observational study of Peyronie's Disease, run by Endo USA Inc., a Keenova Therapeutics Company at 30 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years, men only
- Conditions the study is for
- Peyronie's Disease
- What is being tested?
- Subjects Previously Treated with AA4500
- How many people
- 184 participants
- Where
- 30 sitesUnited States
- Study dates
- Nov 2014to 9 Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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).
- -
Who cannot join
- None
- -
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
United States30 sites
Community Care Physicians, PC
Albany, New York, 12208
Alaska Clinical Research Center, LLC
Anchorage, Alaska, 99503
South Florida Medical Research
Aventura, Florida, 33180
Urology of Indiana LLC
Avon, Indiana, 46123
Urologic Consultants of SE PA
Bala-Cynwyd, Pennsylvania, 19004
Urology Assoc Medical Group
Burbank, California, 91505
Men's Health Boston
Chestnut Hill, Massachusetts, 02467
Uropartners, LLC
Chicago, Illinois, 60612
Tristate Urologic Services dba TUG Research
Cincinnati, Ohio, 45212
Urology Clinics of North Texas, PA
Dallas, Texas, 75231
The Urology Center of Colorado
Denver, Colorado, 80211
Chesapeake Urology Research Associates
Glen Burnie, Maryland, 21061
Bruce R. Gilbert, MD, PhD, PC
Great Neck, New York, 11021
Center for Male Reproductive Medicine
Hackensack, New Jersey, 07601
Metropolitan Urology P.S.C
Jefferson, Indiana, 47130
South Orange County Med Research Center
Laguna Hills, California, 92653
Premier Urology Assoc LLC dba AdvanceMed Research
Lawrenceville, New Jersey, 08648
Idaho Urologic Institute
Meridian, Idaho, 83642
Manhattan Medical Research Practice PLLC
New York, New York, 10016
Florida Urology Associates
Orlando, Florida, 32803
Kansas City Urology Care, PA
Overland Park, Kansas, 66211
Michael A. Werner, MD PC
Purchase, New York, 10577
Associated Urologists of North Carolina
Raleigh, North Carolina, 27612
Virginia Urology
Richmond, Virginia, 23235
Jean Brown Research
Salt Lake City, Utah, 84124
San Diego Sexual Medicine
San Diego, California, 92120
Chesapeake Urology Research Associates
Towson, Maryland, 21204
Urology of Virginia, PLLC
Virginia Beach, Virginia, 23462
Georgis Patsias, M.D., PA
Wellington, Florida, 33449
Dupage Medical Group
Winfield, Illinois, 60190
About this study
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
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
Read the 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.
- Conditions
- Peyronie's Disease
- Being tested
- Subjects Previously Treated with AA4500
- Keywords
- curvature, bend
- Medical subject headings
- Penile Induration, Airway Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subjects Previously Treated with AA4500Drug
no treatment to be administered - observational only
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Subjects Previously Treated with AA4500 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the long-term safety of AA4500 in adult men with Peyronies disease
Measured: 5 years post treatment
Secondary outcomes (1)
To characterize curvature deformity over time in adult men with Peyronies disease who were treated with AA4500
Measured: 5 years post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study startNov 2014
- Primary completion9 Apr 2018
- Study completion9 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peyronie's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02298829
- Sponsor's protocol ID
- AUX-CC-810
- Status last verified
- Jun 2018
- First submitted
- 20 Nov 2014
- Last updated
- 20 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02298829
- Acronym / sponsor ID
- AUX-CC-810
- Conditions
- Peyronie's Disease
- Keywords
- curvature, bend
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics CompanyIndustry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- 9 Apr 2018 (actual)
- Study completion
- 9 Apr 2018 (actual)
- First posted
- 24 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No Treatment | – | Drug: Subjects Previously Treated with AA4500Subjects 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (4 listed)
- 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).
- -
Key exclusion criteria (2 listed)
- None
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subjects Previously Treated with AA4500no treatment to be administered - observational only | Drug | No Treatment |
Primary outcome
To assess the long-term safety of AA4500 in adult men with Peyronies disease
Time frame: 5 years post treatment
1 secondary outcome
To characterize curvature deformity over time in adult men with Peyronies disease who were treated with AA4500
Time frame: 5 years post treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2018.
Related trials for Peyronie's Disease
RecruitingPhase 4
Assessment of the Value of FAPI and FDG-PET-CT in Diagnosis of Acute Phase Peyronie's Disease
Peyronie's Disease
Recruiting
Concurrent Low Intensity Shockwave Therapy on Collagenase Clostridium Histolyticum for Peyronie's Disease
Peyronie Disease, Erectile Dysfunction
Recruiting
Platelet-Rich Plasma for Peyronie's Disease
Peyronies Disease
Active, not recruitingPhase 4
Delayed Dose Collagenase Clostridium Histolyticum (CCH) Protocol for Men With Peyronie's Disease
Peyronie Disease
Active, not recruitingPhase 4
Investigation of Surgery, Collagenase, and Restorex for the Improvement of Peyronie's
Peyronie's Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peyronie's Disease, run by Endo USA Inc., a Keenova Therapeutics Company at 30 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the long-term safety of AA4500 in adult men with Peyronies disease (time frame: 5 years post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2018.