Efficacy and Safety of Xiaflex Injection for Treatment of Dupuytren's Contracture of the Thumb

NCT01265420 | Completed Phase 4 Results

• 1 other identifier: IHtSC-Thumb 101
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the efficacy and safety of clostridial collagenase injections for treatment of Dupuytren's contracture of the thumb and first web space. The investigators hypothesis is that clostridial collagenase will have safety not significantly different to that demonstrated in Phase III clinical trials, and will be effective in significantly reducing the degree of thumb contracture.

Conditions

Dupuytren's Contracture

Keywords

Dupuytren; Dupuytren's Disease

Outcome Measures

Primary Outcomes (1)

• Number Patients Obtaining Clinical Improvement (>50% Reduction in Contracture)

  30 days after last injection

Study Arms (1)

Injectable clostridial collagenase

EXPERIMENTAL

Patients with thumb 1st web contracture secondary to Dupuytren's disease will be treated with 0.58mg of collagenase

Biological: Injectable clostridial collagenase

Interventions

Injectable clostridial collagenase BIOLOGICAL

Injection of 0.58mg clostridial collagenase into Dupuytren's cord, up to three injections

Also known as: Xiaflex

Injectable clostridial collagenase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult subjects (\> 18 years) of either gender with an MP and/or IP joint contracture and a palpable cord of \> 20 degrees of the thumb
• First web space contracture with a palpable cord due to Dupuytren's contracture

You may not qualify if:

• Prior surgical, percutaneous needle aponeurotomy or Xiaflex treatment for Dupuytren's contracture of the same thumb.
• Any subject using anti-coagulant therapy other than low dose aspirin (up to 150mg/day).
• Any subject in the opinion of the MD investigators with chronic, severe or terminal medical illness which would make them unsuitable for study participation.
• Any subject with known allergy to Xiaflex (Clostridial collagenase).
• Pregnant or nursing female
• Any subject who cannot conform to the study visit schedule

Sponsors & Collaborators

• Indiana Hand to Shoulder Center: lead

Study Sites (1)

Indiana Hand to Shoulder Center

Indianaplis, Indiana, 46260, United States

Location

Related Publications (1)

• Hurst LC, Badalamente MA, Hentz VR, Hotchkiss RN, Kaplan FT, Meals RA, Smith TM, Rodzvilla J; CORD I Study Group. Injectable collagenase clostridium histolyticum for Dupuytren's contracture. N Engl J Med. 2009 Sep 3;361(10):968-79. doi: 10.1056/NEJMoa0810866.

  PMID: 19726771 BACKGROUND

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

Limitations and Caveats

1 patient was seen at Day 10, but not at day 30. At Day 10, patient met the primary endpoint

Results Point of Contact

• Title: F. Thomas D. Kaplan
• Organization: Indiana Hand to Shoulder Center

tdk@hand.md

317-875-9105

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 21, 2010
• First Posted: December 23, 2010
• Study Start: December 1, 2010
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: April 30, 2015
• Results First Posted: April 9, 2015

Record last verified: 2015-04

Locations

US (1)