Musculoskeletal Diseases

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Nervous System Diseases

Contracture

Dupuytren Contracture

Fibroma

Neoplasms, Fibrous Tissue

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Muscular Diseases

Connective Tissue Diseases

Subjects may have received up to five injections of AA4500 0.58 mg into the cords of the affected hand, with each injection separated by at least 30 days. Individual cords may have received up to a maximum of three AA4500 injections.

AA4500

Veronica Urdaneta, MD

Study AUX-CC-858 was an open-label continuation of the double-blind Study AUX-CC-857 (NCT00528606). Subjects who complete the Day 90 visit after their initial injection in Study AUX-CC-857 (NCT00528606) entered into Study AUX-CC-858. Subjects who required further treatment in Study AUX-CC-858, either because their treated metacarpophalangeal and/or proximal interphalangeal (PIP) joints did not have a reduction in contracture to 5° or less, the cord affecting that joint received less than three injections of AA4500, or they had other eligible cords that received no treatment in AUX-CC-857 (NCT00528606), had the option to receive up to five injections of AA4500 in this extension study. Subjects requiring further treatment were followed for efficacy and safety on Days 1, 7, and 30 after each injection, with injections separated by four weeks. Follow-up visits for the determination of efficacy and safety were conducted on Day 90, Month 6, and Month 9.

This study was designed to be part of the larger clinical program, for adult patients with Dupuytren's contracture with a palpable cord, where the data from 2 pivotal Placebo-Controlled studies (AUX-CC-857 (NCT00528606) and AUX-CC-859 (NCT00533273)) and 7 non-pivotal studies were evaluated.

AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Advanced Dupuytren's Disease

A Phase 3, Open-Label Extension Study of the Safety and Efficacy of AA4500 in the Treatment of Subjects With Advanced Dupuytren's Disease

Successfully treated or clinical success in non-primary joints defined as reduction in contracture to within 0-5° of normal within 30 days of injection.

Clinical improvement in non-primary joints defined as ≥50% reduction from baseline in the degree of contracture within 30 days after injection

Percent change in degree of contracture in non-primary joints measured as 100 \* (baseline contracture - last available post-injection contracture)/baseline contracture.

Change in degree of range of motion in non-primary joints measured as last available post-injection range of motion - baseline range of motion

Clinical success in non-primary joints defined as reduction in contracture to within 0-5° of normal within 30 days of injection, displayed in post injection time point categories

Clinical success in non-primary joints defined as reduction in contracture to within 0-5° of normal within 30 days of injection.

Endo Pharmaceuticals

This study was designed to be part of the larger clinical program. For information regarding XIAFLEX-associated Serious and Non-serious Adverse events please refer to the XIAFLEX Medication Guide \& XIAFLEX Prescribing Information (see links above)

collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints

AA4500 0.58 mg

Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints

Age, Categorical

Age, Continuous

Sex: Female, Male

White

Hispanic

Race/Ethnicity, Customized

United States

Region of Enrollment

Clinical Trial Coordinator

Evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture \>5° and at least 1 post-injection contracture measurement. For the purpose of analysis, 13 subjects with non-primary joints treated with AA4500 in double-blind study AUX-CC-857 are included in overall number of participants.

Reduction in Contracture to 5° or Less

Clinical Improvement After the Last Injection

Percent Reduction From Baseline Contracture After the Last Injection

Change From Baseline Range of Motion After the Last Injection

Injection 1, Day 1

Injection 1, Day 7

Injection 1, Day 30

Injection 2, Day 0

Injection 2, Day 1

Injection 2, Day 7

Injection 2, Day 30

Injection 3, Day 0

Injection 3, Day 1

Injection 3, Day 7

Injection 3, Day 30

Did not reach Clinical Success

Time to Reach Clinical Success

Clinical Success After the First Injection

Clinical Improvement After the First Injection

Percent Reduction From Baseline Contracture After the First Injection

Change From Baseline Range of Motion After the First Injection

Collagenase clostridium histolyticum 0.58 mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints

Overall Study

Lipoma

Neoplasms, Adipose Tissue

Subjects must present with 2 lipomas; one to receive AA4500 and one to receive placebo simultaneously

placebo

Zachary E Gerut, MD

The purpose of this study is to determine whether collagenase is effective in reducing the surface area of a subcutaneous benign lipoma.

This study will evaluate the safety and efficacy of a Food and Drug Administration (FDA) approved drug (XIAFLEX) in the treatment of lipoma (fatty tumors). The fat in the lipoma is like normal fat except that it is enclosed in a balloon-like structure which is made of collagen (fibrous tissue). Treatment of the lipoma with an injection of XIAFLEX (a protein that breaks down collagen fibers) may dissolve the collagen/fibrous strands thereby decreasing the size of the lipoma or removing it. Each subject must have two lipomas; one lipoma to be treated with placebo and one lipoma to be treated with study drug, both to be observed similarly throughout the trial.

Double Blind Study to Evaluate the Efficacy of Collagenase Histolyticum in the Treatment of Lipoma

A Double Blind Study to Evaluate the Safety and Efficacy of Collagenase Clostridium Histolyticum (AA4500) in the Treatment of Lipoma

Visible surface area is defined as the longest dimension ("length") times the longest dimension perpendicular to length ("width"). Visible surface area will be analyzed as the percent change from baseline.

The primary efficacy outcome is lipoma visible surface area defined as the longest dimension ("length") times the longest dimension perpendicular to length ("width"). Visible surface area will be analyzed as the percent change from baseline at the 6-month visit.

The number of participants with at least 50% decrease in visible lipoma surface area of lipoma relative to baseline

Change from baseline in lipoma length Calculated as the percent change from baseline for length of the lipoma treated with AA4500 and the lipoma treated with placebo.

Subjects very satisfied or somewhat satisfied with study treatment based upon Subject Questionnaire

Advance Biofactures Corporation

Gerut, Zachary, M.D.

Treatment emergent adverse events were collected after the date of administration of study medication through the last visit at 6 months post administration.

single injection of 0.58 mg study drug

AA4500: Subjects must present with 2 lipomas; one to receive AA4500 and one to receive placebo simultaneously

single injection of placebo

placebo: Placebo

Placebo

single injection of 0.58 mg study drug and placebo

Subjects must present with 2 lipomas; one to receive AA4500 and one to receive placebo simultaneously

AA4500 and Placebo

Gender

Race (NIH/OMB)

Dr. Zachary E. Gerut, Sponsor/Investigator

Each subject received a single injection of 1 mL containing 0.58 mg AA4500

Each subject received a single injection of 1 mL placebo

All 19 subjects enrolled with 2 lipomas. All received AA4500 in one lipoma and placebo in the other lipoma.

Percent Change From Baseline in Surface Area of the Lipoma at Six Months

Responder Analysis

Each participants received a single injection of 1 mL containing 0.58 mg AA4500

Each participant received a single injection of 1 mL placebo

Percent Change From Baseline in Greatest Dimension (Length) of Lipoma at 6 Months

1 participant did not complete the questionnaire at the final visit; therefore the analysis population was based upon 18 participants

Subject Satisfaction

Change in Visible Surface Area

Each subject received a single injection of 1 mL containing 0.58 mg AA4500 in one lipoma and a single injection of 1 mL placebo in another lipoma

Lipoma #1 was randomized to AA4500 or placebo with Lipoma #2 receiving the alternate intervention

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Advanced Dupuytren's Disease	NCT00528424	Advanced Dupuyt...	AA4500	18 Years -	Endo Pharmaceuticals
Double Blind Study to Evaluate the Efficacy of Collagenase Histolyticum in the Treatment of Lipoma	NCT02249052	Lipoma	AA4500 placebo	18 Years - 75 Years	Gerut, Zachary, M.D.
AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Advanced Dupuytren's Disease	NCT00528424	Advanced Dupuyt...	AA4500	18 Years -	Endo Pharmaceuticals

Spots Global Cancer Trial Database for aa4500

Every month we try and update this database with for aa4500 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for aa4500

Every month we try and update this database with for aa4500 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for aa4500 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.