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Additional Xiaflex® Treatment in Patients With Peyronie's Disease Recurrence, Worsening, or Incomplete Response

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03767452
Recruitment Status : Recruiting
First Posted : December 6, 2018
Last Update Posted : December 6, 2018
Sponsor:
Collaborator:
Endo Pharmaceuticals
Information provided by (Responsible Party):
Manhattan Medical Research Practice, PLLC

Brief Summary:
Subjects who have had an incomplete response to previous Xiaflex® will receive up to 4 additional cycles of treatment.

Condition or disease Intervention/treatment Phase
Peyronie's Disease Drug: Xiaflex® 0.58 mg Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 4, Single-Center, Multiple-Dose, Open-Label Trial to Evaluate the Efficacy of Additional Xiaflex® Treatment in Patients With Peyronie's Disease Recurrence, Worsening, or Incomplete Response After Prior Xiaflex® Treatment
Actual Study Start Date : October 4, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Single-Arm
Xiaflex® 0.58 mg, 2 injections separated by 1 to 3 days, repeated after 6 weeks for up to 4 treatment cycles.
Drug: Xiaflex® 0.58 mg
0.25 mL injections.




Primary Outcome Measures :
  1. Change in the degree of penile curvature [ Time Frame: From Screening up to 24 weeks ]
    Measurable change in the curvature of penis



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Willing and able to provide written informed consent to participate in the study.
  2. Male aged ≥18 years old at screening.
  3. Previously received Xiaflex® treatment and had a partial or complete response.

    • Partial response is defined as receiving ≤ 4 cycles of Xiaflex® and achieving a penile curvature of ≥ 15 degrees and < 90 degrees.
    • Complete response is defined as receiving ≤ 4 cycles of Xiaflex® and achieving a penile curvature of < 15 degrees.
  4. Has a diagnosis of Peyronie's disease with a penile curvature of ≥ 30 and ≤ 90 degrees at the screening visit.
  5. Has a penile curvature of at ≥ 30 degrees in the dorsal, lateral, or dorsal/lateral plane at the screening visit. It must be possible to delineate the single plane of maximal curvature for evaluation during the study.
  6. Able and willing to comply with restrictions where intercourse or any other sexual activity is prohibited during each treatment cycle and for at least 2 weeks after each injection cycle.
  7. Able and willing to perform home modeling sessions between injection cycles.
  8. Is in good health based on medical history evaluation and in the judgment of the principal investigator.

Exclusion Criteria:

  1. Has a penile curvature of < 30 degrees or > 90 degrees at the screening visit.
  2. Previous allergic reaction to XIAFLEX®.
  3. Has any of the following conditions:

    • Chordee in the presence or absence of hypospadias
    • Thrombosis of the dorsal penile artery and or vein
    • Infiltration by a benign or malignant mass resulting in penile curvature
    • Infiltration by an infectious agent, such as lymphogranuloma venereum
    • Ventral curvature from any cause
    • Presence of an active sexually transmitted disease
    • Known active hepatitis B or C
    • Known human immune deficiency virus (HIV)
  4. Has previously undergone surgery for Peyronie's disease.
  5. Has an erection which, in the opinion of the investigator, is insufficient to accurately measure the subject's penile deformity after administration of the prostaglandin E1 (PGE1), Trimix®, or similar erection inducing agent.
  6. Has a calcified plaque that, in the opinion of the investigator, would prevent proper administration of the study medication.
  7. Has an isolated hourglass deformity of the penis.
  8. Has a plaque causing a curvature of the penis located proximal to the base of the penis where injection of local anesthetic would interfere with the injection of Xiaflex®.
  9. Has received intralesional or injection therapy for Peyronie's disease including interferon, verapamil, or Xiaflex® < 6 months prior to screening.
  10. Has used antiplatelet or anti-coagulants (e.g. coumadin, Plavix®, Eliquis®, Effient®) within 7 days prior to each Xiaflex® injection. Daily aspirin of 81 mg is acceptable.
  11. Has had extracorporeal shock wave therapy (ESWT) for the correction of Peyronie's disease within the 6 months prior to screening or plans to have ESWT at any time during the study.
  12. Has uncontrolled hypertension as determined by the investigator.
  13. Has a recent history of stroke, bleeding, or other significant medical condition which, in the investigator's opinion, would make the subject unsuitable for enrollment in the study.
  14. Has a planned surgical procedure during anticipated study participation.
  15. Is unwilling or unable to cooperate with the requirements of the study including completion of all scheduled study visits.
  16. Has received investigational drug or treatment within 30 days of the first dose Xiaflex®.

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): NCT03767452


Contacts
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Contact: Harper Scott 212-480-3333 info@manhattanmedicalresearch.com

Locations
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United States, New York
Manhattan Medical Research Practice, PLLC Recruiting
New York, New York, United States, 10016
Contact: Harper Scott    212-480-3333    info@manhattanmedicalresearch.com   
Sponsors and Collaborators
Manhattan Medical Research Practice, PLLC
Endo Pharmaceuticals
Investigators
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Principal Investigator: Jed Kaminetsky, MD Principal Investigator

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Responsible Party: Manhattan Medical Research Practice, PLLC
ClinicalTrials.gov Identifier: NCT03767452     History of Changes
Other Study ID Numbers: MMR032018
First Posted: December 6, 2018    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Manhattan Medical Research Practice, PLLC:
Recurrence
Incomplete Response
Worsening
Curvature

Additional relevant MeSH terms:
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Recurrence
Penile Induration
Disease Attributes
Pathologic Processes
Penile Diseases
Genital Diseases, Male
Connective Tissue Diseases