A Pharmacokinetic Study of AA4500 (XIAFLEX™, Proposed Name) in Subjects With Dupuytren's Contracture

NCT00528931 | Completed Phase 1 Results

• 1 other identifier: AUX-CC-855
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase 1, open-label, single-dose pharmacokinetic study in subjects with Dupuytren's contracture conducted at one site in the United States. All subjects received a single dose of AA4500 0.58 mg, which was injected directly into the cord affecting either the metacarpophalangeal (MP) or proximal interphalangeal (PIP) joint. Pharmacokinetic blood samples were collected before dosing, at predetermined time points through the 24 hours after dosing, Day 7, and Day 30. Efficacy and safety assessments were performed up to 30 days after the AA4500 0.58 injection. 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.

Conditions

Dupuytren's Contracture

Keywords

Assessment of AUX I and/or AUX II in human plasma

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With AUX I and AUX II Detected in Their Blood After a Single Dose of AA4500

  AUX I and AUX II are the constituent protein collagenases of collagenase clostridium histolyticum (AA4500). Plasma concentrations of AUX I and AUX II were assessed through an enzymye-linked-immunoabsorbent assay (ELISA).

  Before dosing, at predetermined time points through the 24 hours after dosing, Day 7, and Day 30

Secondary Outcomes (4)

• Clinical Success

  30 days after treatment to the primary joint

• Clinical Improvement

  30 days after treatment to the primary joint

• Percent Change From Baseline Contracture

  Baseline, 30 days after treatment to the primary joint

• Change From Baseline Range of Motion

  Baseline, 30 days after treatment to the primary joint

Study Arms (1)

AA4500 0.58 mg

EXPERIMENTAL

Biological: collagenase clostridium histolyticum

Interventions

collagenase clostridium histolyticum BIOLOGICAL

Single dose of AA4500 0.58 mg into the cord

Also known as: XIAFLEX®, AA4500

AA4500 0.58 mg

Eligibility Criteria

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

You may qualify if:

• Subjects with a diagnosis of Dupuytren's contracture, with a fixed flexion deformity of at least one finger, other than the thumb, that had a contracture at least 20°, but not greater than 100° for MP (80° for PIP) joints, caused by a palpable cord.
• Had a positive "table top test," defined as the inability to simultaneously place the affected finger(s) and palm flat against a table top.
• Were naive to AA4500 treatment.
• Were judged to be in good health.

You may not qualify if:

• Had a chronic muscular, neurological, or neuromuscular disorder that affected the hands.
• Had received treatment for Dupuytren's contracture within 90 days of the AA4500 injection to the MP or PIP selected, including surgery (fasciectomy or surgical fasciotomy), needle aponeurotomy/fasciotomy, or injection of verapamil and/or interferon on the selected primary joint within 90 days before the first dose of study drug.
• Had a known recent history of stroke, bleeding, a disease process that affected the hands, or other medical condition, which in the investigator's opinion, would make the subject unsuitable for enrollment in the study.

Sponsors & Collaborators

• Endo Pharmaceuticals: lead

Study Sites (1)

Providence Clinical Research

Burbank, California, 91505, United States

Location

Related Links

• XIAFLEX Prescribing Information

MeSH Terms

Conditions

Dupuytren Contracture

Interventions

Microbial Collagenase

Condition Hierarchy (Ancestors)

Fibroma; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Contracture; Muscular Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Clinical Trial Coordinator
• Organization: Endo Pharmaceuticals, Inc.

clinicalsite.inquiries@endo.com

Study Officials

• Veronica Urdaneta, MD

  Endo Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2007
• First Posted: September 12, 2007
• Study Start: September 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: March 1, 2008
• Last Updated: October 5, 2017
• Results First Posted: August 20, 2012

Record last verified: 2017-09

Locations

US (1)