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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Auxilium Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00528931
First received: September 11, 2007
Last updated: July 11, 2012
Last verified: July 2012

September 11, 2007
July 11, 2012
September 2007
December 2007   (final data collection date for primary outcome measure)
Number of Subjects With AUX I and AUX II Detected in Their Blood After a Single Dose of AA4500 [ Time Frame: Before dosing, at predetermined time points through the 24 hours after dosing, Day 7, and Day 30 ] [ Designated as safety issue: No ]
Plasma concentrations of AUX I and AUX II after a single dose of AA4500 [ Time Frame: Before dosing, at predetermined time points through the 24 hours after dosing, Day 7, and Day 30 ]
Complete list of historical versions of study NCT00528931 on ClinicalTrials.gov Archive Site
  • Clinical Success [ Time Frame: 30 days after treatment to the primary joint ] [ Designated as safety issue: No ]
    A clinical success is defined as a reduction in contracture (ie, flexion deformity) to ≤ 5° of normal as measured by finger goniometry 30 days after an injection. If the Day 30 visit is missing, the last observation carried forward (LOCF) completed after the injection (Day 1 or Day 7) will be used to determine clinical success
  • Clinical Improvement [ Time Frame: 30 days after first treatment to the primary joint ] [ Designated as safety issue: No ]
    A clinical improvement is defined as a ≥ 50% reduction from baseline in contracture after an injection
  • Percent Reduction From Baseline Contracture [ Time Frame: 30 days after first treatment to the primary joint ] [ Designated as safety issue: No ]
  • Change From Baseline Range of Motion [ Time Frame: 30 days after first treatment to the primary joint ] [ Designated as safety issue: No ]
    Difference between the finger extension angle and finger flexion angle expressed in degrees
  • Time to First Achieve and Maintain Clinical Success [ Time Frame: First evaluation visit on which clinical success is achieved and maintained through the Day 30 evaluation of the primary joint ] [ Designated as safety issue: No ]
    Time to clinical success is defined as the number of days after the first injection in the joint to reach clinical success
  • Actual change and the percent change in degree of flexion and range of motion from baseline.
  • Safety
Not Provided
Not Provided
 
A Pharmacokinetic Study of AA4500 (XIAFLEX™, Proposed Name) in Subjects With Dupuytren's Contracture
A Phase 1, Open-Label Study to Assess the Pharmacokinetics and Safety of a Single Injection of AA4500 0.58 mg in Subjects With Dupuytren's Contracture

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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Dupuytren's Contracture
Biological: collagenase clostridium histolyticum
Single dose of AA4500 0.58 mg into the cord
Other Names:
  • XIAFLEX®
  • AA4500
Experimental: AA4500 0.58 mg
Intervention: Biological: collagenase clostridium histolyticum
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
March 2008
December 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00528931
AUX-CC-855
No
Auxilium Pharmaceuticals
Auxilium Pharmaceuticals
Not Provided
Study Director: John Rodzvilla, MD Auxilium Pharmaceuticals, Inc
Auxilium Pharmaceuticals
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP