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A Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of Long-acting Growth Hormone (Somapacitan) Compared to Daily Dosing of Norditropin® SimpleXx® in Children With Growth Hormone Deficiency

NCT ID: NCT01973244

Last Updated: 2020-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-16

Study Completion Date

2014-11-04

Brief Summary

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This trial is conducted in Europe and Asia. The aim of the trial is to investigate safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of a single dose of long-acting growth hormone (NNC0195-0092, somapacitan) compared to daily dosing of Norditropin® SimpleXx® (somatropin) in children with growth hormone deficiency.

Detailed Description

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Conditions

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Growth Hormone Disorder Growth Hormone Deficiency in Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NNC0195-0092 (somapacitan)

Group Type EXPERIMENTAL

somapacitan

Intervention Type DRUG

A single dose administered subcutaneously (s.c., under the skin) of 4 different doses of NNC0195-0092 in an escalating order.

Each subject will be allocated to one dose level only. After completion of each dose cohort, a safety evaluation will be conducted prior to dose escalation.

Norditropin®

Group Type ACTIVE_COMPARATOR

somatropin

Intervention Type DRUG

Administered subcutaneously (s.c., under the skin) once daily for 7 days. The daily dose is 0.03 mg/kg/day.

Interventions

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somapacitan

A single dose administered subcutaneously (s.c., under the skin) of 4 different doses of NNC0195-0092 in an escalating order.

Each subject will be allocated to one dose level only. After completion of each dose cohort, a safety evaluation will be conducted prior to dose escalation.

Intervention Type DRUG

somatropin

Administered subcutaneously (s.c., under the skin) once daily for 7 days. The daily dose is 0.03 mg/kg/day.

Intervention Type DRUG

Other Intervention Names

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NNC0195-0092

Eligibility Criteria

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Inclusion Criteria

* Confirmed diagnosis of GHD (growth hormone deficiency) as defined by two different GH (growth hormone) stimulation tests, peak GH level below or equal to 7.0 ng/ml. For children with three or more pituitary hormone deficiencies only one GH stimulation test will be needed. If in accordance with country specific practice, growth hormone deficiency can be defined by only one GH stimulation test, peak GH level below or equal to 7.0 ng/ml.
* Pre-pubertal children at screening. Boys: Tanner stage 1 and age above or equal to 6 years and below 13 years. Girls: Tanner stage 1 and age above or equal to 6 years and below 12 years
* Body weight above or equal to 16.0 kg and below or equal to 50.0 kg
* Stable GH replacement treatment for at least 3 months

Exclusion Criteria

* History or presence of malignancy
* Overt diabetes mellitus (fasting blood glucose above or equal to 7.0 mmol/l)
Minimum Eligible Age

6 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Graz, , Austria

Site Status

Novo Nordisk Investigational Site

Linz, , Austria

Site Status

Novo Nordisk Investigational Site

Vienna, , Austria

Site Status

Novo Nordisk Investigational Site

Brussels, , Belgium

Site Status

Novo Nordisk Investigational Site

Brussels, , Belgium

Site Status

Novo Nordisk Investigational Site

Paris, , France

Site Status

Novo Nordisk Investigational Site

Toulouse, , France

Site Status

Novo Nordisk Investigational Site

Haifa, , Israel

Site Status

Novo Nordisk Investigational Site

Jerusalem, , Israel

Site Status

Novo Nordisk Investigational Site

Kfar Saba, , Israel

Site Status

Novo Nordisk Investigational Site

Petah Tikva, , Israel

Site Status

Novo Nordisk Investigational Site

Tel Litwinsky, , Israel

Site Status

Novo Nordisk Investigational Site

Skopje, , North Macedonia

Site Status

Novo Nordisk Investigational Site

Bergen, , Norway

Site Status

Novo Nordisk Investigational Site

Ljubljana, , Slovenia

Site Status

Novo Nordisk Investigational Site

Barcelona, , Spain

Site Status

Novo Nordisk Investigational Site

Esplugues Llobregat(Barcelona), , Spain

Site Status

Novo Nordisk Investigational Site

Santiago de Compostela, , Spain

Site Status

Novo Nordisk Investigational Site

Vitoria-Gasteiz, , Spain

Site Status

Novo Nordisk Investigational Site

Stockholm, , Sweden

Site Status

Novo Nordisk Investigational Site

Basel, , Switzerland

Site Status

Novo Nordisk Investigational Site

Geneva, , Switzerland

Site Status

Countries

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Austria Belgium France Israel North Macedonia Norway Slovenia Spain Sweden Switzerland

References

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Juul Kildemoes R, Hojby Rasmussen M, Agerso H, Overgaard RV. Optimal Monitoring of Weekly IGF-I Levels During Growth Hormone Therapy With Once-Weekly Somapacitan. J Clin Endocrinol Metab. 2021 Jan 23;106(2):567-576. doi: 10.1210/clinem/dgaa775.

Reference Type BACKGROUND
PMID: 33313798 (View on PubMed)

Papathanasiou T, Agerso H, Damholt BB, Hojby Rasmussen M, Kildemoes RJ. Population Pharmacokinetics and Pharmacodynamics of Once-Daily Growth Hormone Norditropin(R) in Children and Adults. Clin Pharmacokinet. 2021 Sep;60(9):1217-1226. doi: 10.1007/s40262-021-01011-3. Epub 2021 Apr 17.

Reference Type DERIVED
PMID: 33864240 (View on PubMed)

Juul RV, Rasmussen MH, Agerso H, Overgaard RV. Pharmacokinetics and Pharmacodynamics of Once-Weekly Somapacitan in Children and Adults: Supporting Dosing Rationales with a Model-Based Analysis of Three Phase I Trials. Clin Pharmacokinet. 2019 Jan;58(1):63-75. doi: 10.1007/s40262-018-0662-5.

Reference Type DERIVED
PMID: 29671202 (View on PubMed)

Battelino T, Rasmussen MH, De Schepper J, Zuckerman-Levin N, Gucev Z, Savendahl L; NN8640-4042 Study Group. Somapacitan, a once-weekly reversible albumin-binding GH derivative, in children with GH deficiency: A randomized dose-escalation trial. Clin Endocrinol (Oxf). 2017 Oct;87(4):350-358. doi: 10.1111/cen.13409. Epub 2017 Aug 8.

Reference Type DERIVED
PMID: 28656605 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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2013-000013-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1138-2206

Identifier Type: OTHER

Identifier Source: secondary_id

REec-2014-0688

Identifier Type: REGISTRY

Identifier Source: secondary_id

JapicCTI-142663

Identifier Type: REGISTRY

Identifier Source: secondary_id

NN8640-4042

Identifier Type: -

Identifier Source: org_study_id