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

NCT ID: NCT01247675

Last Updated: 2017-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2011-05-31

Brief 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.

Conditions

Adult Growth Hormone Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

ACP-001 (TransCon hGH)

Intervention Type: DRUG

s.c., weekly injection

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

Group Type: EXPERIMENTAL

ACP-001 (TransCon hGH)

Intervention Type: DRUG

s.c., weekly injection

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

Group Type: EXPERIMENTAL

ACP-001 (TransCon hGH)

Intervention Type: DRUG

s.c., weekly injection

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

Group Type: ACTIVE_COMPARATOR

Omnitrope

Intervention Type: DRUG

s.c., daily injection

Interventions

ACP-001 (TransCon hGH)

s.c., weekly injection

Intervention Type: DRUG

ACP-001 (TransCon hGH)

s.c., weekly injection

Intervention Type: DRUG

ACP-001 (TransCon hGH)

s.c., weekly injection

Intervention Type: DRUG

Omnitrope

s.c., daily injection

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ascendis Pharma A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Beckert, MD

Role: STUDY_DIRECTOR

Ascendis Pharma A/S

Locations

Aarhus University Hospital

Aarhus, , Denmark

Charité University Hospital Berlin

Berlin, , Germany

University Hospital Genova

Genova, , Italy

Karolinska University Hospital

Stockholm, , Sweden

Countries

Denmark; Germany; Italy; Sweden

Other Identifiers

ACP-001 CT-002

Identifier Type: -

Identifier Source: org_study_id