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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT01247675 |
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Date of registration:
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23/11/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Safety, Pharmacokinetic and Pharmacodynamic Study of ACP-001 (TransCon hGH) in Adults With Growth Hormone Deficiency
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Scientific title:
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A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACP-001 in Adult Patients With Growth Hormone Deficiency |
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Date of first enrolment:
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November 2010 |
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Target sample size:
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37 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01247675 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Denmark
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Germany
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Italy
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Sweden
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Contacts
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Name:
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Michael Beckert, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ascendis Pharma A/S |
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Key inclusion & exclusion criteria
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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
Age minimum:
20 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Adult Growth Hormone Deficiency
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Intervention(s)
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Drug: ACP-001 (TransCon hGH)
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Drug: Omnitrope
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Primary Outcome(s)
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Incidence of Treatment Emergent Anti-hGH Binding Antibody Formation
[Time Frame: Start of study treatment through Day 42]
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Number of Subjects Reporting Local Tolerability Events (Assessed by the Patient and Investigator)
[Time Frame: Start of study treatment through Week 4]
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Secondary Outcome(s)
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Cmax of hGH
[Time Frame: Days 22 to 29]
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Emax of IGF-I
[Time Frame: Days 22 to 29]
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Secondary ID(s)
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ACP-001 CT-002
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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