40
Participants
Start Date
February 29, 2008
Primary Completion Date
August 31, 2009
Study Completion Date
August 31, 2009
C2L-OCT-01 PR, 10 or 20 mg
The first three injections of study medication will be given at V1 (Day 1), V2 (35 days) and V3 (70 days). Dose titration and/or injection interval adjustment will be allowed during the Treatment Period should any patients have a mean GH concentration below 1.0 ng/mL or above 2.5 ng/mL. Dose titration (10, 20 or 30 mg) and/or injection interval adjustment (4, 5 or 6 weeks) will be allowed at V3, V6 and V9 based on clinical symptoms and the mean GH concentration determined at V2, V5 and V8.
C2L-OCT-01 PR, 20 mg
The first three injections of study medication will be given at V1 (Day 1), V2 (Day 35) and V3 (Day 70). Dose titration and/or injection interval adjustment will be allowed during the Treatment Period should any patients have a mean GH concentration below 1.0 ng/mL or above 2.5 ng/mL. Dose titration (10, 20 or 30 mg) and/or injection interval adjustment (4, 5 or 6 weeks) will be allowed at V3, V6 and V9 based on clinical symptoms and the mean GH concentration determined at V2, V5 and V8.
Kaleida Health/Diabetes Center of WNY, Buffalo
The Cleveland Clinic, Cleveland
UCLA Medical Center Division of Neurosurgery, Los Angeles
VA Puget Sound Health Care System, Tacoma
Stanford University Medical Center, Stanford
Republican Centre for Medical Rehabilitation and Water-therapy, Minsk
Semmelweis Egyetem Altalanos Orvostudomanyi, Budapest
"Institute of Endocrinology C.I. Parhon Bucharest", Bucharest
Institute of Endocrinology, University Clinical Center, Belgrade
V.P. Komisarenko Institute of Endocrinology and Metabolism, AMS Ukraine, Kiev
Lead Sponsor
Ambrilia Biopharma, Inc.
INDUSTRY