Administration of Two Injections for Multiple Dupuytren's Contractures
Condition: Dupuytren's Contracture
MeSH terms: Dupuytren Contracture; Contracture
Intervention: AA4500 collagenase clostridium histolyticum
Intervention description: 2 concurrent injections (0.58 mg) into 2 cords on the same hand
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objectives of this study are to assess the safety and efficacy of concurrent
      administration of two injections of AA4500 into the same hand of subjects with multiple
      Dupuytren's contractures caused by palpable cords.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Provide written informed consent

          2. Be a man or woman ≥ 18 years of age

          3. Have a diagnosis of Dupuytren's disease and have at least 2 fixed-flexion contractures
             on the same hand that are ≥ 20º in PIP and/or MP joints in fingers, other than the
             thumbs, which are caused by palpable cords suitable for treatment

          4. Have a positive "table top test" defined as the inability to simultaneously place the
             affected finger(s) and palm flat against a table top

          5. Either be using an accepted method of birth control (ie, surgical sterilization; intra
             uterine contraceptive device; oral contraceptive; diaphragm or condom in combination
             with contraceptive cream, or jelly or foam) and have negative pregnancy testing before
             administration of AA4500, if a female of childbearing potential, or be a
             postmenopausal female (no menses for at least 1 year or hysterectomy)

          6. Not have any clinically significant medical history or condition(s) 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. Be able to comply with the study visit schedule as specified in the protocol

        Exclusion Criteria:

          1. Received surgery (fasciectomy or surgical fasciotomy) and/or needle
             aponeurotomy/fasciotomy on the selected joints to be treated within 90 days before the
             first injection of AA4500

          2. Has a chronic muscular, neurological, or neuromuscular disorder that affects the hands

          3. Has a known systemic allergy to collagenase or any other excipient of AA4500

          4. Has received any collagenase treatments (eg, Santyl® ointment and/or XIAFLEX/XIAPEX)
             within 30 days before injection of AA4500

          5. 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)

          6. Has a known recent history of stroke, bleeding, or other medical condition, which in
             the investigator's opinion would make the subject unsuitable for enrollment in the
             study

          7. Is known to be immunocompromised or human immunodeficiency virus (HIV) positive

          8. Has a history of illicit drug abuse or alcoholism within the year before injection of
             AA4500

          9. Received an investigational drug within 30 days before injection of AA4500

         10. Is a pregnant or lactating female

         11. 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

         12. Has jewelry on the hand to be treated that cannot be removed