ong-term study of safety, curvature and presence of antibodies in men previously treated with AA4500 for Peyronie's Disease
- Conditions
- Peyronie's DiseaseMedDRA version: 19.0Level: LLTClassification code 10034766Term: Peyronies diseaseSystem Organ Class: 10038604 - Reproductive system and breast disordersMedDRA version: 19.0Level: PTClassification code 10034765Term: Peyronie's diseaseSystem Organ Class: 10038604 - Reproductive system and breast disordersTherapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
- Registration Number
- EUCTR2014-004239-37-DK
- Lead Sponsor
- Endo Ventures Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 750
To be eligible for this study a subject had to:
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, orAUX-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).
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 638
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 112
None
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objectives of this study are:<br>- to assess the long-term safety of AA4500 in adult men with Peyronie's disease<br>- to characterise curvature deformity over time in adult men with Peyronie's disease who were treated with AA4500<br>- to assess the long-term immunogenicity profile of AA4500 in adult men with Peyronie's disesase;Secondary Objective: Not applicable;Primary end point(s): - Curvature deformity measurements<br>- Flaccid penile examination parameters<br>- PDQ (3 domains)<br>- IIEF (5 domains)<br>will be summarised descriptively by yearly interval<br><br>- Determination of the proportion of subjects with positive titres of anti-AUX-I and anti-AUX-II and mean log titre levels of anti-AUX-I and anti-AUX-II<br>- Analysis of a subset of subjects with neutralizing antibodies to AUX-I and AUX-II at Visit 1 will also be summarized by yearly interval;Timepoint(s) of evaluation of this end point: Annually
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable