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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01247675
Other study ID # ACP-001 CT002
Secondary ID
Status Completed
Phase Phase 2
First received November 23, 2010
Last updated June 2, 2013
Start date November 2010
Est. completion date May 2011

Study information

Verified date June 2013
Source Ascendis Pharma A/S
Contact n/a
Is FDA regulated No
Health authority Austria: Agency for Health and Food SafetyDenmark: Danish Medicines AgencyGermany: Federal Institute for Drugs and Medical DevicesItaly: The Italian Medicines AgencySweden: Medical Products Agency
Study type Interventional

Clinical Trial Summary

This study investigates the 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).


Recruitment information / eligibility

Status Completed
Enrollment 37
Est. completion date May 2011
Est. primary completion date May 2011
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 70 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
ACP-001 (TransCon PEG hGH)
s.c., weekly injection
ACP-001 (TransCon PEG hGH)
s.c., weekly injection
ACP-001 (TransCon PEG hGH)
s.c., weekly injection
Human Growth Hormone
s.c., daily injection over 28 days

Locations

Country Name City State
Denmark Aarhus University Hospital Aarhus
Germany Charité University Hospital Berlin Berlin
Italy University Hospital Genova Genova
Sweden Karolinska University Hospital Stockholm

Sponsors (1)

Lead Sponsor Collaborator
Ascendis Pharma A/S

Countries where clinical trial is conducted

Denmark,  Germany,  Italy,  Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety and Tolerability (Adverse events, vital signs, safety laboratory, immunogenicity) Adverse events, vital signs, safety laboratory, immunogenicity 4 weeks Yes
Secondary Change of IGF-I levels over time Change from baseline after wash-out phase 4 weeks No
Secondary Change of IGFBP-3 over time Change from baseline after wash-out phase 4 weeks No