Abstract

The purpose of this study is to determine the long-term safety and effectiveness of an investigational drug, B2036-PEG, in patients with acromegaly, which is caused by growth hormone secreting tumors. This drug blocks the actions of growth hormone. This study will also determine if B2036-PEG is more effective than the two previously available drugs because they work by different mechanisms which are only effective in selected patients. All patients with acromegaly have high growth hormone levels and have growth hormone receptors. Therefore, this drug may have some effect in nearly all patients. To date, multiple studies in humans and animals have shown a decrease in one of the blood proteins (IGF-I) that is responsible for many of the signs and symptoms seen in acromegaly. Similar studies performed in humans at UNC and across the US have shown that the drug is well tolerated. This study will determine the long-term safety and effectiveness of different daily dosages during a long-term treatment regimen. The dose will be titrated in an attempt to normalized IGF-I values.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000046-40
Application #
6303961
Study Section
Project Start
1999-12-01
Project End
2000-11-30
Budget Start
1998-10-01
Budget End
1999-09-30
Support Year
40
Fiscal Year
2000
Total Cost
$241
Indirect Cost

  Institution

Name
University of North Carolina Chapel Hill
Department
Type
DUNS #
078861598
City
Chapel Hill
State
NC
Country
United States
Zip Code
27599

  Publications

Little, Jayne; Parker, Ben; Lunt, Mark et al. (2018) Glucocorticoid use and factors associated with variability in this use in the Systemic Lupus International Collaborating Clinics Inception Cohort. Rheumatology (Oxford) 57:677-687
Abdullah, Lubna H; Coakley, Raymond; Webster, Megan J et al. (2018) Mucin Production and Hydration Responses to Mucopurulent Materials in Normal versus Cystic Fibrosis Airway Epithelia. Am J Respir Crit Care Med 197:481-491
Martin, Maureen P; Naranbhai, Vivek; Shea, Patrick R et al. (2018) Killer cell immunoglobulin-like receptor 3DL1 variation modifies HLA-B*57 protection against HIV-1. J Clin Invest 128:1903-1912
Haas, David W; Bradford, Yuki; Verma, Anurag et al. (2018) Brain neurotransmitter transporter/receptor genomics and efavirenz central nervous system adverse events. Pharmacogenet Genomics 28:179-187
Venuto, Charles S; Lim, Jihoon; Messing, Susan et al. (2018) Inflammation investigated as a source of pharmacokinetic variability of atazanavir in AIDS Clinical Trials Group protocol A5224s. Antivir Ther 23:345-351
Malinen, Melina M; Kauttonen, Antti; Beaudoin, James J et al. (2018) Novel In Vitro Method Reveals Drugs that Inhibit Solute Transporter Alpha/Beta (OST?/?). Mol Pharm :
Li, Binglan; Verma, Shefali S; Veturi, Yogasudha C et al. (2018) Evaluation of PrediXcan for prioritizing GWAS associations and predicting gene expression. Pac Symp Biocomput 23:448-459
Hanly, John G; Li, Qiuju; Su, Li et al. (2018) Cerebrovascular Events in Systemic Lupus Erythematosus: Results From an International Inception Cohort Study. Arthritis Care Res (Hoboken) 70:1478-1487
Barber, Megan R W; Hanly, John G; Su, Li et al. (2018) Economic Evaluation of Lupus Nephritis in the Systemic Lupus International Collaborating Clinics Inception Cohort Using a Multistate Model Approach. Arthritis Care Res (Hoboken) 70:1294-1302
Rini, Christine; Vu, Maihan B; Lerner, Hannah et al. (2018) A qualitative study of patient and provider perspectives on using web-based pain coping skills training to treat persistent cancer pain. Palliat Support Care 16:155-169

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