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Safety, PK/PD (Pharmacokinetics/Pharmacodynamics) and Efficacy of ACP-001 Weekly Versus Daily hGH in Children With Growth Hormone Deficiency (GHD)

NCT01947907 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2017-01-19

Study results available
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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.

Conditions

  • Growth Hormone Deficiency (GHD)

Interventions

DRUG

ACP-001

Once weekly subcutaneous injection

DRUG

Human Growth Hormone

Once daily subcutaneous injection of human Growth Hormone

Sponsors & Collaborators

  • Ascendis Pharma A/S

    lead INDUSTRY

Principal Investigators

  • Pierre Chatelain, Prof, MD · University of Lyon

  • Michael Beckert, MD · Ascendis Pharma A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2015-07-31
Completion
2015-09-30

Countries

  • Belarus
  • Bulgaria
  • Czechia
  • Egypt
  • France
  • Germany
  • Greece
  • Hungary
  • Poland
  • Romania
  • Russia
  • Slovenia
  • Turkey (Türkiye)
  • Ukraine

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01947907 on ClinicalTrials.gov