Long-Acting Growth Hormone Study Protocol

[~MaryO~]

http://www.acurian.com/patient....lcthtml

 

Trial Information

 

Summary: Long-Acting Growth Hormone Study Protocol

 

The purpose of this Phase I research study is to determine if an investigational, long-acting growth hormone preparation is safe for human use, to measure its levels in blood, and to determine the most effective dose to give to patients who produce less growth hormone than normal.

 

If you qualify for this study, you would receive either a single dose of the long-acting growth hormone or two doses 7 or 14 days apart. If you receive a single dose, you would spend 24 hours immediately thereafter as an inpatient in the Clinical Research Center at the University of Pennsylvania and then make 12 or 13 outpatient visits there during the next 27 days. If you receive two doses, you would spend 24 hours as an inpatient at the Clinical Research Center after each of the two doses and then make 17 or 18 outpatient visits there during the next 34 days.

 

Inclusion Criteria:

 

Ages 18 - 65 years

Pituitary or hypothalamic disease causing deficiencies of thyroid, adrenal, and gonadal hormones

Replacement of thyroid, adrenal, and gonadal hormones

 

Exclusion Criteria:

Acromegaly

Active significant acute or chronic disease

Diabetes mellitus, rheumatoid arthritis, inflammatory bowel disease, lupus erythematosus or carpal tunnel syndrome

Cancer within the last 5 years except for adequately treated skin cancer

Allergy to yeast products

Pituitary surgery within the last 3 months

Pregnancy or nursing

 

Contact:

 

Louise Loh, RN, Research Coordinator

University of Pennsylvania Health System

Division of Endocrinology

First Floor Maloney Building

36th and Spruce Streets

Philadelphia, PA 19104

Telephone: 215-898-5664

Fax: 215-662-4500

Email: lohl@mail.med.upenn.edu