CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 37 enrolled
Drug / intervention
ACP-001 (TransCon hGH) +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01247675
NCT01247675Phase 2Completed
CompareCT.gov

A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACP-001 in Adult Patients With Growth Hormone Deficiency

Ascendis Pharma A/S·interventional·Posted Nov 24, 2010·Updated Mar 9, 2017

In Brief

A Phase 2 clinical trial evaluating ACP-001 (TransCon hGH) and Omnitrope for Adult Growth Hormone Deficiency. Completed, enrolled 37 participants across 4 sites in 4 countries.

Detailed Summary

This study investigates the safety, tolerability, pharmacokinetic profile (PK), and pharmacodynamic response (PD) of three different doses of ACP-001 given once-a-week compared to one dose-level of an approved daily human growth hormone product over a period of 4 weeks (4 weekly administrations versus 28 daily administrations) in adults with Growth Hormone Deficiency.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdult Growth Hormone Deficiency
CountriesDenmark, Germany, Italy, Sweden
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 24, 2010
Enrollment StartNov 1, 2010
Primary CompletionMay 1, 2011
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 15.6 years ago

Interventions

ACP-001 (TransCon hGH)drug

s.c., weekly injection

ACP-001 (TransCon hGH)drug

s.c., weekly injection

ACP-001 (TransCon hGH)drug

s.c., weekly injection

Omnitropedrug

s.c., daily injection