Continuous Subcutaneous Hydrocortisone Infusion in Congenital Adrenal Hyperplasia

NCT01771328 | Unknown Phase 2 DMC

• 1 other identifier: 2012/749
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Adrenal Hyperplasia, Congenital

Keywords

Adrenal Hyperplasia, Congenital

Outcome Measures

Primary Outcomes (1)

• Androgen levels

  Androgen levels as parameters of adequate suppression of androgen production

  3 months

Secondary Outcomes (14)

• Steroid metabolism

  4 months

• bone metabolism

  3 months

• fasting glucose

  4 months

• body mass index

  3 months

• Dual-energy X-ray absorptiometry (DXA)

  6 months

Study Arms (2)

hydrocortisone

ACTIVE COMPARATOR

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

cortisone acetate

ACTIVE COMPARATOR

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

Interventions

Hydrocortisone DRUG

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.

Also known as: Solu-Cortef

hydrocortisone

Cortisone acetate DRUG

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.

Also known as: Cortisone

cortisone acetate

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Haukeland University Hospital: lead

Study Sites (1)

Haukeland Universitetssykehus, Department of Medicine

Bergen, 5021, Norway

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Adrenal Hyperplasia, Congenital

Interventions

Hydrocortisone; hydrocortisone hemisuccinate; Cortisone

Condition Hierarchy (Ancestors)

Adrenogenital Syndrome; Disorders of Sex Development; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Steroid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Adrenal Gland Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids

Study Officials

• Kristian Løvås, MD, PhD

  Haukeland University Hospital, Department of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristian Løvås, MD, PhD

CONTACT

+47 55977996; kral@helse-bergen.no

Katerina Simunkova, MD, PhD

CONTACT

+47 55974603; katerina.simunkova@med.uib.no

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2013
• First Posted: January 18, 2013
• Study Start: February 1, 2013
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: December 21, 2016

Record last verified: 2016-12

Locations

NO (1)