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Generated: December 10, 2018

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CLINICAL TRIALS PROFILE FOR PEGVISOMANT

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Clinical Trials for Pegvisomant

Trial ID Title Status Sponsor Phase Summary
NCT00017927 A Study of the Effects of Pegvisomant on Growth Hormone Excess in McCune-Albright Syndrome Completed National Institute of Dental and Craniofacial Research (NIDCR) Phase 3 This study will examine the effect of pegvisomant on growth hormone excess in patients with McCune-Albright syndrome (MAS). Patients with this disease have polyostotic fibrous dysplasia-a condition in which areas of normal bone are replaced with fibrous growth similar to scar tissue, abnormal skin pigmentation (birth marks) and precocious (early) puberty. About 10 percent of patients have excess growth hormone (GH). GH stimulates the production of another hormone called insulin-like growth factor 1 (IGF-1). Together, GH and IGF-1 affect bone growth. The excess of these hormones in MAS can cause overgrowth of the bones of the face, hands and feet, excess sweating, or increased height. Pegvisomant is a synthetic drug that binds to cell receptors where GH would normally bind, thus preventing the naturally occurring hormone from stimulating IGF-1 and bone growth as it normally would. This study will see if pegvisomant will reduce blood levels of IGF-1 and mitigate the effects of growth hormone excess, including bone pain, bone turnover, hand and foot swelling and sweating, and abnormal levels of related hormones. Patients who were screened for polyostotic fibrous dysplasia and MAS under NIH protocol 98-D-0145 and were found to have MAS with excess growth hormone are eligible for this 36-week study. The screening protocol includes a history and physical examination, blood and urine tests, hearing, eye and dental examinations, pain and physical function evaluations, endocrine and bone screening tests, various bone imaging studies, including magnetic resonance imaging (MRI) and computed tomography (CT) scans and bone biopsy in patients over 6 years old. Participants in the current study will receive daily injections of either pegvisomant or placebo (an inactive substance) for 12 weeks, followed by a 6-week "washout" period with no drug. Then, patients who received placebo will be switched, or "crossed over," to receive pegvisomant for another 12 weeks, and those who received pegvisomant will receive placebo. This will be followed by another 6-week washout period. The drug and placebo will be injected under the skin, similar to insulin injections. Blood and urine tests will be done at the beginning of the study and repeated every 6 weeks until the study ends.
NCT00068029 Pegvisomant And Sandostatin LAR Combination Study Completed Pfizer Phase 4 The purpose of this study is to compare the safety and tolerability of combination therapy with Sandostatin LAR plus Pegvisomant to that of Sandostatin LAR alone or Pegvisomant alone.
NCT00068042 A Study To Compare The Efficacy And Safety Of Pegvisomant To That Of Sandostatin Lar Depot In Patients With Acromegaly Completed Pfizer Phase 4 The purpose of the study is to determine if Pegvisomant is more efficacious than Sandostatin LAR Depot in normalizing IGF-I levels in treatment naive patients with acromegaly.
NCT00143416 Long Term Study With B2036-PEG Completed Pfizer Phase 3 Primary objective: To investigate the efficacy and safety of Pegvisomant in Japanese patients with acromegaly.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Pegvisomant

Condition Name

Condition Name for Pegvisomant
Intervention Trials
Acromegaly 16
Insulin Resistance 2
Metabolic Syndrome 1
Breast Neoplasms 1
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Condition MeSH

Condition MeSH for Pegvisomant
Intervention Trials
Acromegaly 17
Insulin Resistance 3
Endocrine System Diseases 2
Dwarfism, Pituitary 2
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Clinical Trial Locations for Pegvisomant

Trials by Country

Trials by Country for Pegvisomant
Location Trials
United States 22
Canada 10
Spain 6
Germany 6
Brazil 6
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Trials by US State

Trials by US State for Pegvisomant
Location Trials
California 5
Oregon 2
Virginia 2
North Carolina 2
Massachusetts 2
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Clinical Trial Progress for Pegvisomant

Clinical Trial Phase

Clinical Trial Phase for Pegvisomant
Clinical Trial Phase Trials
Phase 4 9
Phase 3 4
Phase 2 2
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Clinical Trial Status

Clinical Trial Status for Pegvisomant
Clinical Trial Phase Trials
Completed 17
Active, not recruiting 3
Terminated 2
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Clinical Trial Sponsors for Pegvisomant

Sponsor Name

Sponsor Name for Pegvisomant
Sponsor Trials
Pfizer 9
University of Aarhus 3
Cedars-Sinai Medical Center 2
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Sponsor Type

Sponsor Type for Pegvisomant
Sponsor Trials
Other 20
Industry 13
NIH 3
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Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
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Accenture
McKesson
Teva
Dow
Covington
Federal Trade Commission
AstraZeneca

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