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Collagenase

Novel CCH Protocol for Peyronie's Disease

Phase 4

Recruiting

Led By Landon Trost, MD

Research Sponsored by Charitable Union for the Research and Education of Peyronie's Disease

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Previously completed 6-8 CCH injections

Men with Peyronie's Disease

Must not have

Prior surgical treatment on the penis (other than circumcision)

Inability to complete 8 additional CCH injections

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Drug Has Already Been Approved

All Individual Drugs Already Approved

Pivotal Trial

Summary

This trial compares the effects of a new CCH administration protocol in men who haven't responded to CCH before.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

CCH may cause swelling, pain at the injection site, bruising, bleeding, and possibly penile fracture. The RestoreX device might lead to discomfort or skin issues where it contacts the body.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have completed 6-8 injections for my condition.

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I am a man with Peyronie's Disease.

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I am older than 18 years.

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I received CCH injections without a Restorex device, following the IMPRESS protocol.

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My condition slightly improved with previous CCH treatment.

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I have a noticeable hard lump in my penis, indicating Peyronie's Disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had surgery on my penis, not including circumcision.

Select...

I cannot complete 8 more CCH injections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Penile Curvature

Peyronie's Disease Questionnaire Outcomes

Secondary study objectives

Adverse events - 12 months - pain, sensation, swelling

Adverse events - 6 months - pain, sensation, swelling

Change in penile curvature durability

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

RestoreX

2018

N/A

~90

0 / 8Eligibility criteria met