CompletedPhase 2

Long Term Follow up Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children

United States, Belarus, Greece48 participantsStarted 2014-02

Plain-language summary

Protocol CP-4-004-OLE (Open Label Extension) is designed as a long-term, open-label extension using single patient use, multi-dose, disposable pre-filled pen.

Who can participate

Age range3 Years – 11 Years

SexALL

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Exclusion criteria

✕. Children with past or present intracranial tumor growth as confirmed by an MRI scan (with contrast).
✕. History of radiation therapy or chemotherapy.
✕. Malnourished children defined as:
✕. Serum albumin below the lower limit of normal (LLN) according to the reference ranges of central laboratory;
✕. Serum iron below the lower limit of normal (LLN) according to the reference ranges of central laboratory;
✕. BMI \< -2 Standard Deviation for age and sex;
✕. Children with psychosocial dwarfism.
✕. Children born small for gestational age (SGA - birth weight and/or birth length \< -2 SD for gestational age).

What they're measuring

Annualized Height Velocity

Timeframe: 8 years

Delta Height SDS Every 12 Months

Timeframe: 8 years

Trial details

NCT IDNCT02500316

SponsorOPKO Health, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-11

Results submitted2025-03-20

View on ClinicalTrials.gov More Growth Hormone Deficiency (GHD) trials