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Long-term Safety, Curvature Deformity Characterization, and Immunogenicity Over Time in Subjects Previously Treated With AA4500 for Peyronies Disease

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ClinicalTrials.gov Identifier: NCT02298829
Recruitment Status : Completed
First Posted : November 24, 2014
Last Update Posted : June 20, 2018
Sponsor:
Information provided by (Responsible Party):
Endo Pharmaceuticals

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

Condition or disease Intervention/treatment
Peyronie's Disease Drug: Subjects Previously Treated with AA4500

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.


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Study Type : Observational
Actual Enrollment : 184 participants
Observational Model: Cohort
Time Perspective: Prospective
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 Start Date : November 2014
Actual Primary Completion Date : April 9, 2018
Actual Study Completion Date : April 9, 2018

Group/Cohort Intervention/treatment
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.
Drug: Subjects Previously Treated with AA4500
no treatment to be administered - observational only




Primary Outcome Measures :
  1. To assess the long-term safety of AA4500 in adult men with Peyronies disease [ Time Frame: 5 years post treatment ]

Secondary Outcome Measures :
  1. To characterize curvature deformity over time in adult men with Peyronies disease who were treated with AA4500 [ Time Frame: 5 years post treatment ]

Other Outcome Measures:
  1. To assess the long-term immunogenicity profile of AA4500 in adult men with Peyronies disease [ Time Frame: 5 years post treatment ]

Biospecimen Retention:   Samples Without DNA
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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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).
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).

    -

    Exclusion Criteria:

    None

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02298829


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Sponsors and Collaborators
Endo Pharmaceuticals

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Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02298829     History of Changes
Other Study ID Numbers: AUX-CC-810
First Posted: November 24, 2014    Key Record Dates
Last Update Posted: June 20, 2018
Last Verified: June 2018

Keywords provided by Endo Pharmaceuticals:
curvature
bend

Additional relevant MeSH terms:
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Penile Induration
Penile Diseases
Genital Diseases, Male
Connective Tissue Diseases