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Study Evaluating rhMBP-2/CPM in Open Wedge Osteotomies

Last updated on March 14, 2019

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Osteoarthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
45-70 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Male or female subjects 45 to 70 years of age

- Within 96 hours prior to dosing, the subject underwent a successful open wedge tibial
osteotomy to correct medial compartment OA of the knee.

- Female subjects of childbearing potential must have a negative pregnancy test
(hospital acceptable test), upon hospitalization for OWO and agree to use medically
approved contraception for the duration of the study.

Other inclusion applies.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Subjects with pre-existing conditions of the knee or tibia that would confound an
interpretation of results.

- Subjects for whom surgery in the opposite knee is planned during the 6 months of
follow-up.

- Subjects with a history of malignancy or radiotherapy or chemotherapy for malignancy
within the past 5 years, except subjects with a history of basal skin carcinoma.

Other exclusion applies.

NCT00243295
Pfizer
Completed
Study Evaluating rhMBP-2/CPM in Open Wedge Osteotomies

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