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

NCT03767452 | Unknown Phase 4 FDA Drug

• 1 other identifier: MMR032018
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Peyronie's Disease

Keywords

Recurrence; Incomplete Response; Worsening; Curvature

Outcome Measures

Primary Outcomes (1)

• Change in the degree of penile curvature

  Measurable change in the curvature of penis

  From Screening up to 24 weeks

Study Arms (1)

Single-Arm

EXPERIMENTAL

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

Interventions

Xiaflex® 0.58 mg DRUG

0.25 mL injections.

Single-Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to provide written informed consent to participate in the study.
• Male aged ≥18 years old at screening.
• 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.
• Has a diagnosis of Peyronie's disease with a penile curvature of ≥ 30 and ≤ 90 degrees at the screening visit.
• 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.
• 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.
• Able and willing to perform home modeling sessions between injection cycles.
• Is in good health based on medical history evaluation and in the judgment of the principal investigator.

You may not qualify if:

• Has a penile curvature of \< 30 degrees or \> 90 degrees at the screening visit.
• Previous allergic reaction to XIAFLEX®.
• 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)
• Has previously undergone surgery for Peyronie's disease.
• 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.
• Has a calcified plaque that, in the opinion of the investigator, would prevent proper administration of the study medication.
• Has an isolated hourglass deformity of the penis.

Sponsors & Collaborators

• Manhattan Medical Research Practice, PLLC: lead
• Endo Pharmaceuticals: collaborator

Study Sites (1)

Manhattan Medical Research Practice, PLLC

New York, New York, 10016, United States

RECRUITING

MeSH Terms

Conditions

Penile Induration; Recurrence

Interventions

Microbial Collagenase

Condition Hierarchy (Ancestors)

Penile Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Collagenases; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases

Study Officials

• Jed Kaminetsky, MD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Harper Scott

CONTACT

212-480-3333; info@manhattanmedicalresearch.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2018
• First Posted: December 6, 2018
• Study Start: October 4, 2018
• Primary Completion: December 1, 2019
• Study Completion: February 1, 2020
• Last Updated: December 7, 2018

Record last verified: 2018-12

Locations

US (1)