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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01247675
Recruitment Status : Completed
First Posted : November 24, 2010
Results First Posted : March 9, 2017
Last Update Posted : March 9, 2017
Sponsor:
Information provided by (Responsible Party):
Ascendis Pharma A/S

Tracking Information
First Submitted Date  ICMJE November 23, 2010
First Posted Date  ICMJE November 24, 2010
Results First Submitted Date  ICMJE November 3, 2016
Results First Posted Date  ICMJE March 9, 2017
Last Update Posted Date March 9, 2017
Study Start Date  ICMJE November 2010
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 20, 2017)
  • Number of Subjects Reporting Local Tolerability Events (Assessed by the Patient and Investigator) [ Time Frame: Start of study treatment through Week 4 ]
    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 ]
    Number of subjects with treatment emergent anti-hGH binding antibodies
Original Primary Outcome Measures  ICMJE
 (submitted: November 23, 2010)
Safety and Tolerability (Adverse events, vital signs, safety laboratory, immunogenicity) [ Time Frame: 4 weeks ]
Adverse events, vital signs, safety laboratory, immunogenicity
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 20, 2017)
  • Cmax of hGH [ Time Frame: Days 22 to 29 ]
    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 ]
    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
Original Secondary Outcome Measures  ICMJE
 (submitted: November 23, 2010)
  • Change of IGF-I levels over time [ Time Frame: 4 weeks ]
    Change from baseline after wash-out phase
  • Change of IGFBP-3 over time [ Time Frame: 4 weeks ]
    Change from baseline after wash-out phase
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety, Pharmacokinetic and Pharmacodynamic Study of ACP-001 (TransCon hGH) in Adults With Growth Hormone Deficiency
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Adult Growth Hormone Deficiency
Intervention  ICMJE
  • Drug: ACP-001 (TransCon hGH)
    s.c., weekly injection
  • Drug: Omnitrope
    s.c., daily injection
Study Arms  ICMJE
  • 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
    Intervention: Drug: ACP-001 (TransCon hGH)
  • 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
    Intervention: Drug: ACP-001 (TransCon hGH)
  • 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
    Intervention: Drug: ACP-001 (TransCon hGH)
  • 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
    Intervention: Drug: Omnitrope
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 2, 2013)
37
Original Estimated Enrollment  ICMJE
 (submitted: November 23, 2010)
32
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark,   Germany,   Italy,   Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01247675
Other Study ID Numbers  ICMJE ACP-001 CT-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Ascendis Pharma A/S
Original Responsible Party Michael Beckert, MD (CMO), Ascendis Pharma A/S
Current Study Sponsor  ICMJE Ascendis Pharma A/S
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Michael Beckert, MD Ascendis Pharma A/S
PRS Account Ascendis Pharma A/S
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP