Novel CCH Protocol for Peyronie's Disease
Recruiting in Palo Alto (17 mi)
Overseen byLandon Trost, MD
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Waitlist Available
Sponsor: Charitable Union for the Research and Education of Peyronie's Disease
No Placebo Group
Prior Safety Data
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?Compare key clinical outcomes between controls and men treated with a novel CCH administration protocol among men previously unresponsive to CCH administration.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you can continue using PDE5 inhibitors if needed for satisfactory erections.
What data supports the idea that Novel CCH Protocol for Peyronie's Disease is an effective treatment?
The available research shows that the Novel CCH Protocol, which involves using a drug called collagenase Clostridium histolyticum, is effective for treating Peyronie's Disease. Studies have shown that this treatment can help reduce the curvature of the penis, which is a common problem in this condition. For example, one study found that men treated with this drug experienced improvements in their condition over a long period, up to five years. Another study highlighted that even in cases with different types of penile deformities, the treatment was effective and safe. However, it's important to note that some patients may not respond to the treatment and might need surgery. Overall, the data supports that this drug is a beneficial option for many patients with Peyronie's Disease.
12345What safety data is available for CCH treatment in Peyronie's disease?
Safety data for CCH treatment in Peyronie's disease comes from multiple clinical studies. A pooled safety analysis of six studies showed that patients receiving CCH injections experienced adverse events such as bruising, swelling, hematoma, and corporal rupture in over 50% of cases. However, modified injection techniques and protocols have been proposed to reduce these adverse events. The safety and efficacy of CCH, marketed as Xiaflex, have been demonstrated in clinical trials, and new protocols aim to improve safety by reducing the number of injections and standardizing safety assessments.
56789Is the drug CCH a promising treatment for Peyronie's Disease?
Yes, CCH is a promising treatment for Peyronie's Disease. It has been shown to effectively reduce penile curvature and improve the condition in patients. Studies have demonstrated its success in treating different types of curvature and its long-term safety.
13101112Eligibility Criteria
Men over 18 with Peyronie's Disease who've had little improvement from previous CCH treatments can join. They must have a significant curve in their penis (≥30 degrees), no past penile surgery except circumcision, and be able to get an erection suitable for sex. Severe plaque calcification or inability to complete the treatment disqualifies them.Inclusion Criteria
I have completed 6-8 injections for my condition.
I am a man with Peyronie's Disease.
I can have an erection good enough for sex, with or without medication.
+5 more
Exclusion Criteria
I have no health conditions that prevent me from receiving CCH treatment.
I have had surgery on my penis, not including circumcision.
Severe plaque calcification (i.e. >1 cm shadowing)
+1 more
Participant Groups
The trial is testing a new way of giving CCH injections compared to the old method among men whose Peyronie's Disease didn't respond well before. It includes using a device called RestoreX after not responding to at least 6-8 prior CCH injections without this device.
2Treatment groups
Experimental Treatment
Active Control
Group I: Collagenase Clostridium HistolyticumExperimental Treatment2 Interventions
Men in this cohort would undergo baseline assessments followed by up to 8 injections of CCH (or until curvature is \<15 degrees). Men would then undergo assessments 6 weeks later, followed by a 6-month no treatment phase and then final assessments.
Group II: Control - Crossover to CCHActive Control2 Interventions
Men in this cohort would undergo baseline assessments followed by no treatment for 6 months and then repeat assessments. Men would then cross-over to CCH treatment and undergo up to 8 injections (or until curvature is \<15 degrees). Final assessments would then be performed 6 weeks following the final injection.
CCH administration is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Xiaflex for:
- Peyronie's disease
- Dupuytren's contracture
🇪🇺 Approved in European Union as Xiaflex for:
- Dupuytren's contracture
- Peyronie's disease
🇨🇦 Approved in Canada as Xiaflex for:
- Dupuytren's contracture
- Peyronie's disease
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
The Male Fertility and Peyronie's ClinicOrem, UT
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Who Is Running the Clinical Trial?
Charitable Union for the Research and Education of Peyronie's DiseaseLead Sponsor
References
Safety and Efficacy of Collagenase Clostridium Histolyticum in Peyronie's Disease Men With Ventral Curvatures. [2020]To evaluate the safety and efficacy of collagenase clostridium histolyticum (CCH) in men with ventral penile curvatures secondary to Peyronie's Disease (PD).
Characteristics of Men With Peyronie's Disease and Collagenase Clostridium Histolyticum Treatment Failure: Predictors of Surgical Intervention and Outcomes. [2020]A subset of patients with Peyronie's disease (PD) treated with collagenase clostridium histolyticum (CCH) experience persistent bother and some require surgery.
Clinical efficacy of collagenase Clostridium histolyticum in the treatment of Peyronie's disease by subgroup: results from two large, double-blind, randomized, placebo-controlled, phase III studies. [2022]To examine the efficacy of intralesional collagenase Clostridium histolyticum (CCH) in defined subgroups of patients with Peyronie's disease (PD).
Long-term Curvature Deformity Characterization in Men Previously Treated With Collagenase Clostridium Histolyticum for Peyronie's Disease, Subgrouped by Penile Plaque Calcification. [2022]To examine the long-term (5-year) efficacy and safety of collagenase clostridium histolyticum (CCH) therapy in men with Peyronie's disease and varying degrees of plaque calcification.
Treatment-related Outcomes for Patients With Atypical Peyronie's Disease Using Xiaflex Injections. [2022]To evaluate the efficacy and safety of collagenase Clostridium histolyticum (CCH) for the management of penile deformities in patients presenting with different categories of atypical Peyronie's disease (PD).
Analysis of the clinical safety of intralesional injection of collagenase Clostridium histolyticum (CCH) for adults with Peyronie's disease (PD). [2015]To examine the safety of intralesional injection of collagenase Clostridium histolyticum (CCH) for the treatment of Peyronie's disease (PD), using a pooled safety analysis of patients who received at least one dose of CCH in any of six clinical studies.
A modified technique for intralesional injection of collagenase Clostridium histolyticum for Peyronie's disease results in reduced procedural morbidity using a standardized hematoma classification rubric. [2021]Early clinical trials of injectable collagenase Clostridium histolyticum (CCh) for Peyronie's disease (PD) demonstrated safety and efficacy. Since then, modified injection protocols have been proposed. Adverse events-such as bruising, swelling, hematoma, and corporal rupture-exceed 50% in many studies, but lack of standardization of hematoma severity limits conclusions about the relative safety of protocols. We propose a modification of the standard injection technique that aims to decrease the rates of adverse events. We further describe a hematoma classification rubric that may standardize safety assessment.
Safety and effectiveness of collagenase clostridium histolyticum in the treatment of Peyronie's disease using a new modified shortened protocol. [2018]Label="OBJECTIVES">To evaluate the efficacy and safety of collagenase clostridium histolyticum (CCH; Xiapex® , Xiaflex® ) in the treatment of Peyronie's disease (PD) using a new modified treatment protocol that aims at reducing the number of injections needed and reducing patient visits, thus reducing the duration and cost of treatment.
Efficacy and safety of collagenase Clostridium histolyticum in Peyronie's disease following a modified treatment protocol. [2021]Collagenase Clostridium histolyticum (CCH) is the only approved treatment for conservative management of Peyronie's disease (PD) that has demonstrated efficacy and safety in clinical trials. However, as the standard treatment protocol is time and resource consuming, we are introducing a new CCH treatment protocol with a more cost-effective profile. Our goal is to evaluate its efficacy and safety.
Long-Term Safety and Curvature Deformity Characterization in Patients Previously Treated with Collagenase clostridium Histolyticum for Peyronie's Disease. [2020]We assessed the long-term safety and immunogenicity profile of collagenase clostridium histolyticum and characterized penile curvature deformity over time in patients previously treated for Peyronie's disease.
Successful Treatment of Residual Curvature in Peyronie Disease in Men Previously Treated With Intralesional Collagenase Clostridium Histolyticum. [2018]To determine the success and feasibility of surgically correcting residual curvature after intralesional collagenase clostridium histolyticum (CCH) for the treatment of Peyronie disease (PD).
Effect of collagenase Clostridium histolyticum on penile vascular and morphological parameters in patients with Peyronie's disease. [2022]To examine the changes in penile vascular parameters after the administration of collagenase Clostridium histolyticum (CCH) in patients with Peyronie's disease (PD).