CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 53 enrolled
Drug / intervention
ACP-001 +1 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/NCT01947907
NCT01947907Phase 2Completed
CompareCT.gov

A Multicenter, Phase 2, Randomized, Open Label, Active-controlled, Parallel-group Study Investigating the Safety, Tolerability, and Efficacy of Different Dose Levels of ACP-001 Administered Once Weekly Versus Standard Daily rhGH Replacement Therapy in Pre-pubertal Children With Growth Hormone Deficiency (GHD)

Ascendis Pharma A/S·interventional·Posted Sep 23, 2013·Updated Jan 19, 2017

In Brief

A Phase 2 clinical trial evaluating ACP-001 and Human Growth Hormone for Growth Hormone Deficiency (GHD). Completed, enrolled 53 participants across 36 sites in 14 countries.

Detailed Summary

A six month study of ACP-001, a long-acting growth hormone product, versus standard human growth hormone therapy. ACP-001 will be given once-a-week, standard human growth hormone (hGH) will be given on a daily basis. The primary aim is to demonstrate safety, pharmacokinetics and pharmacodynamics over a period of six months. A secondary objective is the comparison of height velocity (HV) of the ACP-001 treated groups to the daily hGH treatment group.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGrowth Hormone Deficiency (GHD)
CountriesBelarus, Bulgaria, Czechia, Egypt, France, Germany, Greece, Hungary, Poland, Romania, Russia, Slovenia, Turkey (Türkiye), Ukraine
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 23, 2013
Enrollment StartJul 1, 2013
Primary CompletionJul 1, 2015
Study CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 12.8 years ago

Interventions

ACP-001drug

Once weekly subcutaneous injection

Human Growth Hormonedrug

Once daily subcutaneous injection of human Growth Hormone