Growth Hormone Treatment in Children Born Small for Gestational Age (SGA)

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Small for Gestational Age; Foetal Growth Problem

Treatments: Drug: somatropin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00184717

JapicCTI-050137 (Registry Identifier)

GHLIQUID-1517

2017-000914-47 (Registry Identifier)

JapicCTI-050132 (Registry Identifier)

Details and patient eligibility

About

This study is conducted in Japan. The aim of this trial is to assess the efficacy and safety of somatropin in children born small for gestational age (SGA) in Japan.

In the main period, subjects will receive either active treatment for 104 weeks (two dosing regimens) or no treatment for 52 weeks followed by an extension period where subjects who received active treatment for 104 weeks (two years) will continue with the same treatment for further 156 weeks (three years) while those subjects who received no treatment for 52 weeks (one year) will be randomised to receive two dosing regimens for 208 weeks (four years). In total, subjects participate in trial for 260 weeks (five years).

Main period is registered internally at Novo Nordisk as GHLIQUID-1516 while the extension period is registered as GHLIQUID-1517.

Enrollment: 98 patients

Sex: All

Ages: 3 to 8 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• For MAIN period (GHLIQUID-1516):
• Born small for gestational age (SGA) with birth weight and birth length below the 10th percentile for gestational age, and additional either birth length below or equal to -2.0 standard deviation score (SDS) or birth weight below or equal to -2.0 SDS for gestational age
• Growth failure with height at -2.0 SDS or below for chronological age (CA)
• Normal growth hormone (GH) production, defined as peak GH level > 10 ng/mL in one GH provocation test
• For EXTENSION period (GHLIQUID-1517):
• Subjects who completed the main period
• Chronological age (CA) for boys at least 4 years, but maximum 11 years
• Chronological age (CA) for girls at least 4 years, but maximum 10 years

Exclusion criteria

• Subjects with diabetes mellitus
• Subjects suffering from malignancy
• Several medical conditions

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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98 participants in 5 patient groups

0.033 mg / NN-220

Experimental group

Description:

In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime

Treatment:

Drug: somatropin

Drug: somatropin

0.067 mg / NN-220

Experimental group

Description:

In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime

Treatment:

Drug: somatropin

Drug: somatropin

No treatment

No Intervention group

Description:

No somatropin (NN-220) treatment was given in the 52-week main period. Subjects was re-randomised to recive two dosing regimens (0.033 mg/kg/day or 0.067 mg/kg/day) in the 208-week extension period

No treatment --> 0.033 mg

Experimental group

Description:

In the 208-week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period

Treatment:

Drug: somatropin

Drug: somatropin

No treatment --> 0.067 mg

Experimental group

Description:

In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period

Treatment:

Drug: somatropin

Drug: somatropin