Long-term study of safety, curvature and presence of antibodies in men previously treated with AA4500 for Peyronie's Disease

Long-term safety, curvature deformity characterization, and immunogenicity over time in subjects previously treated with AA4500 for Peyronie’s disease in studies AUX-CC-802, AUX-CC-803, AUX CC 804, and AUX-CC-806 - Long-term safety study in men previously treated with AA4500 for Peyronie's Disease

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-004239-37-SE

Enrollment

750

Registered

2014-11-13

Start date

2015-02-26

Completion date

Unknown

Last updated

2018-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peyronie's Disease MedDRA version: 17.1 Level: LLT Classification code 10034766 Term: Peyronies disease System Organ Class: 10038604 - Reproductive system and breast disorders MedDRA version: 17.1 Level: PT Classification code 10034765 Term: Peyronie's disease System Organ Class: 10038604 - Reproductive system and breast disorders

Interventions

Trade Name: Xiapex Product Name: Collagenase clostridium histolyticum Product Code: AA4500 Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: collagenase clostridi

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
Main Objective: The objectives of this study are: - to assess the long-term safety of AA4500 in adult men with Peyronie's disease - to characterise curvature deformity over time in adult men with Peyronie's disease who were treated with AA4500 - 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 - Flaccid penile examination parameters - PDQ (3 domains) - IIEF (5 domains) will be summarised descriptively by yearly interval - 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 - 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	—

Measure

Time frame

Main Objective: The objectives of this study are: - to assess the long-term safety of AA4500 in adult men with Peyronie's disease - to characterise curvature deformity over time in adult men with Peyronie's disease who were treated with AA4500 - 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 - Flaccid penile examination parameters - PDQ (3 domains) - IIEF (5 domains) will be summarised descriptively by yearly interval - 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 - 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

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Denmark, France, Germany, Italy, Spain, Sweden, United Kingdom, United States

Contacts

Public ContactPär Thored

TFS Trial Form Support International AB

par.thored@tfscro.com+46 46 280 1933

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026