Prospective Open-label Investigation of the Non-surgical Treatment with collagenase clostridium histolyticum Xiapex® (X)

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 250

Inclusion Criteria

Subject eligibility should be reviewed and documented by an appropriately qualified member of the investigator’s study team before subjects are included in the study. Subjects must meet all of the following criteria to enter the study:
1. At least 18 years of age and = 70 years.
2. Presenting with a Dupuytren’s contracture of at least 20 degrees caused by a palpable cord in at least one finger other than the thumb.
3. Positive table top test” defined as the inability to simultaneously place the affected finger(s) and palm flat against a table top.
4. In good health, based upon the results of a medical history, physical examination, and safety laboratory profile.
5. Female subjects of child bearing potential must use a highly effective contraception method or be surgically sterilized or be a post menopausal female (ie, no menses for at least 1 year). A pregnancy test will be performed prior to enrollment in the study.
6. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
7. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 250
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 250

Exclusion Criteria

Subjects presenting with any of the following will not be included in the study:
1. Nursing or pregnant, or plan to become pregnant during the treatment phase.
2. On an investigational drug within 30 days prior to the first dose of study drug.
3. Received a treatment on the selected joint, within 90 days of enrollment in the study, for Dupuytren’s contracture including needle aponeurotomy or any surgical procedure.
4. Patients with a known systemic hypersensitivity to collagenase or any of the other product excipients.
5. On anticoagulant medication or has received anticoagulant medication (except aspirin less than 150 mg daily) within 7 days before the first injection.
6. Has any clinically significant medical history or condition(s), including conditions that affect the hands, that would, in the opinion of the investigator, substantially increase the risk associated with the subject’s participation in the protocol or compromise the scientific objectives of the study.
7. Has a chronic muscular, neurological, or neuromuscular disorder that affects the hands.
8. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
9. Has jewelry on the hand to be treated that cannot be removed.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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