CLINICAL TRIALS PROFILE FOR PEGVISOMANT
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All Clinical Trials for Pegvisomant
| Trial ID | Title | Status | Sponsor | Phase | Start Date | 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 | 2001-06-01 | 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 | 2003-10-01 | 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 | 2003-04-01 | 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 | 2004-04-01 | Primary objective: To investigate the efficacy and safety of Pegvisomant in Japanese patients with acromegaly. |
| NCT00151437 ↗ | Canadian Pegvisomant Compassionate Study In Acromegalic Patients | Completed | Pfizer | Phase 4 | 2004-11-01 | The purposes of this study are: 1) to provide SOMAVERT for compassionate use to patients with acromegaly or who have completed clinical trials and were responsive, and 2) to evaluate the safety and tolerability of SOMAVERT. |
| NCT00383708 ↗ | Lanreotide Autogel and Pegvisomant Combination Therapy in Acromegalic Patients | Completed | Ipsen | Phase 3 | 2006-10-01 | The main aim of this study is to assess the efficacy of the co-administration of lanreotide Autogel 120 mg (administered via deep sub-cutaneous injections every 28 days) and pegvisomant (administered at 40 to 120 mg per week via sub-cutaneous injection given once or twice a week) on IGF-1 levels over 28 weeks in acromegalic patients. The primary endpoint will be the percentage of acromegalic patients with normalised (age and sex adjusted) IGF-1 level at the end of the co-treatment period. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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