Trial · Interventional

CompletedPhase 2Results postedRegistry data

A Safety, Pharmacokinetic and Pharmacodynamic Study of ACP-001 (TransCon hGH) in Adults With Growth Hormone Deficiency

NCTNCT01247675Other idACP-001 CT-002

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 2
Enrollment: 37 participants (actual)
Sponsor: Ascendis Pharma A/S · Industry
Design: Randomized · Open label (no masking)
Countries: 4 countries
Denmark, Germany, Italy, Sweden
Start: Nov 2010
Primary completion: May 2011
Completion: May 2011
First posted: 24 Nov 2010 (estimated)
Last update posted: 8 Jul 2026
Conditions: Adult Growth Hormone Deficiency

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201020112012

Ph 2
A Safety, Pharmacokinetic and Pharmacodynamic Study of ACP-001 (TransCon hGH) in Adults With Growth Hormone Deficiency
NCT01247675
Nov 2010 to May 2011

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

ACP-001 (TransCon hGH)Drug
ACP-001 (TransCon hGH)Drug
ACP-001 (TransCon hGH)Drug
OmnitropeDrug

Arms4

Experimental
ACP-001, 0.02 mg hGH/kg/wk
Once weekly subcutaneous injection of ACP-001 equivalent to 0.02 mg hGH/kg/week for 4 weeks
Experimental
ACP-001, 0.04 mg hGH/kg/wk
Once weekly subcutaneous injection of ACP-001 equivalent to 0.04 mg hGH/kg/week for 4 weeks
Experimental
ACP-001, 0.08 mg hGH/kg/wk
Once weekly subcutaneous injection of ACP-001 equivalent to 0.08 mg hGH/kg/week for 4 weeks
Active comparator
Omnitrope, 0.04 mg hGH/kg/wk
Once daily subcutaneous injection of human Growth Hormone (Omnitrope) equivalent to 0.04 mg hGH/kg/week for 4 weeks

Primary outcomes2

Outcomes the sponsor listed as primary.

Number of Subjects Reporting Local Tolerability Events (Assessed by the Patient and Investigator)
Time frame · Start of study treatment through Week 4
Registry description
Assessment of local tolerability was performed by examining injection sites by the investigator during study visits, and on the basis of records in the Patient Diary. Assessments included erythema, swelling, or pain.
Incidence of Treatment Emergent Anti-hGH Binding Antibody Formation
Time frame · Start of study treatment through Day 42
Registry description
Number of subjects with treatment emergent anti-hGH binding antibodies

Secondary outcomes(2)

Cmax of hGH
Time frame · Days 22 to 29
Registry description
As part of the following endpoint: Pharmacokinetic (PK) profile of serum human Growth Hormone (hGH) from ACP-001 treated dose groups compared to the PK profile of hGH from the daily Omnitrope treated group. Cmax (maximum value of concentration) values at Week 4
Emax of IGF-I
Time frame · Days 22 to 29
Registry description
As part of the following endpoint: Pharmacodynamic (PD) response of serum Insulin-like Growth Factor-I (IGF-I) from ACP-001 treated dose groups compared to the PD response of IGF-I from the daily Omnitrope treated group. Emax (maximum observed response) values at Week 4

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Start of study treatment through Week 4

Number of Subjects Reporting Local Tolerability Events (Assessed by the Patient and Investigator)

Group	Value (Number of subjects with any symptom)
ACP-001, 0.02 mg hGH/kg/wk	3
ACP-001, 0.04 mg hGH/kg/wk	3
ACP-001, 0.08 mg hGH/kg/wk	2
Omnitrope, 0.04 mg hGH/kg/wk	1

Primary outcomeNumber· Start of study treatment through Day 42

Incidence of Treatment Emergent Anti-hGH Binding Antibody Formation

Group	Value (Participants)
ACP-001, 0.02 mg hGH/kg/wk	0
ACP-001, 0.04 mg hGH/kg/wk	0
ACP-001, 0.08 mg hGH/kg/wk	0
Omnitrope, 0.04 mg hGH/kg/wk	0

Secondary and other outcome results(2)

Secondary outcomeMean· Days 22 to 29

Cmax of hGH

Group	Value (ng/mL)	Spread
ACP-001, 0.02 mg hGH/kg/wk	1.2	0.8
ACP-001, 0.04 mg hGH/kg/wk	1.9	0.9
ACP-001, 0.08 mg hGH/kg/wk	3.8	2.0
Omnitrope, 0.04 mg hGH/kg/wk	2.0	1.1

Secondary outcomeMean· Days 22 to 29

Emax of IGF-I

Group	Value (ng/mL)	Spread
ACP-001, 0.02 mg hGH/kg/wk	71.8	26.9
ACP-001, 0.04 mg hGH/kg/wk	108.6	91.7
ACP-001, 0.08 mg hGH/kg/wk	125.6	70.1
Omnitrope, 0.04 mg hGH/kg/wk	109.8	37.1

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
ACP-001, 0.02 mg hGH/kg/wkACP-001 (TransCon hGH): s.c., weekly injection equivalent to 0.02 mg hGH/kg/wk for 4 weeks	0 / 10	1 / 10	6 / 10
ACP-001, 0.04 mg hGH/kg/wkACP-001 (TransCon hGH): s.c., weekly injection equivalent to 0.04 mg hGH/kg/wk for 4 weeks	0 / 10	0 / 10	9 / 10
ACP-001, 0.08 mg hGH/kg/wkACP-001 (TransCon hGH): s.c., weekly injection equivalent to 0.08 mg hGH/kg/wk	0 / 9	0 / 9	7 / 9
Omnitrope, 0.04 mg hGH/kg/wkHuman Growth Hormone: s.c., daily injection of Omnitrope equivalent to 0.04 mg hGH/kg/wk for 4 weeks	0 / 8	0 / 8	7 / 8

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 20 Years up to 70 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Male or female between 20 to 70 years * Body Mass Index (BMI, kg/m2) of 19.0 to 36.0 kg/m2, both inclusive * Adult Growth Hormone Deficient (AHGD) patients with documented growth hormone deficiency as defined in the Consensus guidelines for the diagnosis and treatment of adults with GH deficiency II (Consensus Guidelines 1998 and 2007) * Fertile females must agree to use appropriate contraceptive methods and have a negative pregnancy test at inclusion * GH replacement therapy for at least 3 months * Willing to maintain current activity level during the trial * Subjects are able and willing to provide written informed consent and authorization for protected health information disclosure in accordance with Good Clinical Practice (GCP) Exclusion Criteria: * History of hypersensitivity and/or idiosyncrasy to any of the test compounds or excipients employed in this study. * Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods. Reliable methods for women are orally administered hormonal contraceptives, surgical intervention (e.g. tubal ligation), intrauterine device (IUD) and sexual abstinence. * Active malignant disease or malignant disease within the last 5 years * Proliferative retinopathy judged by retina-photo within the last year * Heart insufficiency as judged by the investigator and/or NYHA 3 or greater (NYHA criteria for diagnosis of diseases of the heart, 1994) * Subjects with uncontrolled diabetes with an HbA1c above 8.0% and/or insulin treatment * Stable pituitary hormone replacement therapy for less than 3 months * Impaired liver function as judged by the investigator or hepatic transaminases \> 2 times the upper limit of normal * Impaired kidney function as judged by the investigator and/or creatinine clearance \<50 mL/min and/or serum creatinine \> 1.4 mg/dL * Participation in another interventional clinical study involving an investigational compound within 3 months prior to enrolment in this study or participation in another interventional clinical study involving an investigational compound during this study. * Subjects who are unable to comply with the requirements of the study or who in the opinion of the investigator should not participate in the study. * History or presence of alcohol abuse or drug abuse. * Patients with known history for, or presence of, anti-hGH and / or anti-PEG antibodies

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