To treat contractures that have come back when they were previously successfully treated with AA4500 in a prior clinical study

Phase 1

• Conditions: Dupuytren's contracture; MedDRA version: 20.0 Level: PT Classification code 10013872 Term: Dupuytren's contracture System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2011-005065-21-GB
• Lead Sponsor: Auxilium UK Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-02-27
• Study Completion: 2013-10-07
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 52

Inclusion Criteria

To qualify for the study a subject must:
1. Provide written informed consent
2. Be currently participating in the AUX-CC-860 follow-up study
3. Have at least one joint with all of the following:
• The joint was effectively treated (had a correction to 5° or less at the Day 30 evaluation after the last injection of AA4500) in a previous Auxilium Phase 3 study
• The effectively treated joint has an increase in contracture of at least 20°compared with the Day 30 value after the last injection of AA4500 in a previous Auxilium Phase 3 study
• A palpable cord is present in the joint to be treated
4. Be able to comply with the study visit schedule as specified in the protocol
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 4
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

Exclusion Criteria

A subject will be excluded from study participation if he/she:
1. Is a pregnant or lactating female or female intending to become pregnant during the study
2. Has hypersensitivity to AA4500 or any of the AA4500 excipients
3. Is currently receiving or plans to receive anticoagulant medication or has received anticoagulant medication (except for = 150 mg aspirin daily and over-the-counter nonsteroidal anti-inflammatory drugs [NSAIDs]) within 7 days before injection of AA4500

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified