Open Label Extension Study Evaluating Safety and Biological Activity of C2L-OCT-01 PR in Acromegalic Patients

PHASE3CompletedINTERVENTIONAL
Enrollment

63

Participants

Timeline

Start Date

October 31, 2007

Primary Completion Date

June 30, 2009

Study Completion Date

June 30, 2009

Conditions
Acromegaly
Interventions
DRUG

C2L-OCT-01 PR 30 mg

Administered by deep IM (gluteus) on Day 1. Beginning on Day 42, drug injection frequency (6, 5 or 4 weeks) and dose modification/adjustment will be allowed for every 3 drug injections based on the mean serum GH and clinical symptoms obtained at the last visit of study C2L-OCT-01 PR-301 and during the course of this study.

Trial Locations (6)

Unknown

Republican Centre for Medical Rehabilitation and Water-therapy, Minsk

Semmelweis Egyetem Altalanos Orvostudomanyi, Budapest

"Institue of Endocrinology C.I Parhon Bucharest", Bucharest

Institute of Endocrinology, University Clinical Center, Belgrade

Fakultna Nemocnica s Poliklinkow Bratislava, Bratislava

V.P. Komisarenko Institute of Endocrinology and Metabolism, AMS Ukraine, Kiev

Sponsors
All Listed Sponsors
lead

Ambrilia Biopharma, Inc.

INDUSTRY

NCT00635765 - Open Label Extension Study Evaluating Safety and Biological Activity of C2L-OCT-01 PR in Acromegalic Patients | Biotech Hunter | Biotech Hunter