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Continuous Subcutaneous Hydrocortisone Infusion in Congenital Adrenal Hyperplasia (CAH)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT01771328
First received: January 10, 2013
Last updated: January 16, 2013
Last verified: January 2013
History of Changes
  Purpose

The conventional glucocorticoid replacement therapy in congenital adrenal hyperplasia (CAH) renders the cortisol levels unphysiological, which may cause symptoms and long-term complications. Glucocorticoid replacement is technically feasible by continuous subcutaneous hydrocortisone infusion (CSHI), and can mimic the normal diurnal cortisol rhythm. This method was recently applied to treat a patient through a critical phase of puberty. This is a clinical trial aiming to evaluate CSHI treatment in patients with CAH. The main objective is to determine the effects of CSHI on metabolic parameters (androstenedione and 17-hydroxyprogesterone profiles, and testosterone,adrenocorticotropic hormone(ACTH), cortisol, and bone markers), and to determine the required glucocorticoid doses. Secondary objectives are to determine effects on clinical status, body weight, blood pressure and other metabolic parameters, as well as on subjective health status (AddiQoL, SF36).


Condition Intervention Phase
Adrenal Hyperplasia, Congenital
 Drug: Hydrocortisone
Drug: Cortisone acetate
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Continuous Subcutaneous Hydrocortisone Infusion in Congenital Adrenal Hyperplasia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:
  • Androgen levels [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Androgen levels as parameters of adequate suppression of androgen production


Secondary Outcome Measures:
  • Steroid metabolism [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
    levels of ACTH

  • bone metabolism [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • fasting glucose [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • body mass index [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Dual-energy X-ray absorptiometry (DXA) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    body composition, bone mineral density

  • Subjective health status [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    questionnaire

  • waist circumference [ Time Frame: 3 month ] [ Designated as safety issue: No ]
    cm

  • hip circumference [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    cm

  • blood pressure [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • fasting insulin [ Time Frame: 3-4 months ] [ Designated as safety issue: No ]
  • glycated haemoglobin (Hb1AC) [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • lipid levels [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • c-reactive protein [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Steroid metabolism [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
    cortisol levels


Estimated Enrollment: 20
Study Start Date: February 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: hydrocortisone
Treatment B ( Solu-Cortef) the initial standard dose of 10mg/m2/24hrs. Hydrocortisone infusate will be given as Solu-Cortef Act-o-Vial 50mg/ml, produced by Pfizer. Treatment will take 4 months.
 Drug: Hydrocortisone
Initial standard dose of 10mg/m2/24hrs administered by pump during the treatment period, it will take 4 months. Body surface area will be calculated according to the nomogram from the formula of Du Bois and Du Bois.
Other Name: Solu-Cortef
Active Comparator: cortisone acetate
Treatment A (Cortisone tbl.) is current treatment, i.e. glucocorticoid and mineralocorticoid replacement according to best clinical judgement. This treatment period will take 6 months.
 Drug: Cortisone acetate
Patients will take this tables two times during day according to best clinical practice of therapy of congenital adrenal hyperplasia. Usually Cortisone 25 mg 1 tbl. in the morning and Cortisone 25 1/4 tbl. in the evening. This period will take 6 months.
Other Name: Cortisone

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • verified salt-wasting CAH and simple virilizing CAH, on single prednisone, or hydrocortisone therapy.
  • In case of concomitant endocrine/autoimmune diseases these should be on stable treatment during the study period.

Exclusion Criteria:

  • Patients with diabetes mellitus on insulin pump treatment will not be included in this study
  • cardiovascular disease, active malignant disease and pregnancy, and pharmacological treatment with glucocorticoids or drugs that interfere with cortisol metabolism (antiepileptics, rifampicin, St. Johns wart).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01771328

Locations
Norway
Haukeland Universitetssykehus, Department of Medicine
Bergen, Norway, 5021
Sponsors and Collaborators
Haukeland University Hospital
Investigators
Principal Investigator: Kristian Løvås, MD, PhD Haukeland University Hospital, Department of Medicine
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT01771328     History of Changes
Other Study ID Numbers: 2012/749
Study First Received: January 10, 2013
Last Updated: January 16, 2013
Health Authority: Norway: Regional Ethics Commitee

Keywords provided by Haukeland University Hospital:
Adrenal Hyperplasia, Congenital

Additional relevant MeSH terms:
Adrenal Hyperplasia, Congenital
Adrenogenital Syndrome
Adrenocortical Hyperfunction
Hyperplasia
Disorders of Sex Development
Urogenital Abnormalities
Congenital Abnormalities
Genetic Diseases, Inborn
Steroid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Metabolic Diseases
Adrenal Gland Diseases
Endocrine System Diseases
Gonadal Disorders
Pathologic Processes
 Epinephrine
Epinephryl borate
Cortisone acetate
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Cortisone
Hydrocortisone
Hydrocortisone-17-butyrate
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013