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Optimization of the Dosage Regimen of Growth Hormone Therapy in Children Born Small for Gestational Age

Information source: Merck KGaA
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Small for Gestational Age (SGA)

Intervention: Saizen® (Drug); Saizen® (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Merck KGaA

Official(s) and/or principal investigator(s):
Laurence Fresneau, M.D., Study Director, Affiliation: Merck Serono S.A.S, France

Summary

Multicentric, open-label, randomized, pilot comparative study in parallel groups comparing 1 group of subjects receiving 0. 057 milligram/kilogram/day (mg/kg/day) or 0. 40 mg/kg/week of Saizen® during 1 year to 1 group receiving 0. 035 mg/kg/day (0. 24 mg/kg/week) of Saizen® during 1 year after an initial 3-year treatment of recombinant human growth hormone (r-hGH) therapy with 0. 057 mg/kg/day in both groups.

Clinical Details

Official title: Optimization of the Dosage Regimen With Growth Hormone Therapy in Children Born Small for Gestational Age. An Open Label, Randomized, Pilot Study, Comparing in Children Treated for 3 Years, the Efficacy of a Saizen Treatment at the Same Dose Versus a Lower Maintenance Dose Prolonged During 1 Additional Year.

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Height Velocity

Secondary outcome:

Change From Baseline in Height-Standard Deviation Score (H-SDS) at Month 6 and Month 12

Height Velocity-Standard Deviation Score (HV-SDS)

Change From Baseline in Height at Month 6

Change From Baseline in Bone Age at Month 12

Insulin Like Growth Factor-1 (IGF-1) Levels

Insulin Like Growth Factor Binding Protein-3 (IGFBP-3) Levels

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

Eligibility

Minimum age: 6 Years. Maximum age: 11 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: To be eligible for inclusion / randomization into this study, the subjects must fulfill all of the following criteria (if there is no inclusion phase, the inclusion criteria will be considered as inclusion criteria for randomization):

- Written consent form signed by the parents / legal guardian, and child if possible

- Subject born SGA and receiving a r-hGH therapy for this pathology

- Recombinant human growth hormone (r-hGH) started at the maximal chronological age of

7 years for girls and 8 years for boys

- Treatment with r-hGH started for at least 30 months and less than 36 months at 0. 057

mg/kg/day

- Height gain during the first 2 years of GH treatment > 1 SD compared with the initial

value Exclusion Criteria: To be eligible for inclusion in this study the subjects must not meet any of the following criteria:

- Known hypersensitivity to Somatropin or any of the excipients

- Active neoplasia (either newly diagnosed or recurrent)

- Intracranial hypertension

- Known diabetes mellitus

- Proliferative or preproliferative diabetic retinopathy

- Evidence of any progression or recurrence of an underlying intra-cranial space

occupying lesion

- Obesity defined as degree 1 on the corpulence curves

- Precocious puberty

- Pubertal status: Tanner breast development stage > 2 for girls, and testicular volume

> 4 milliliter (mL) or testicular length > 3 centimeter (cm) and/or testosterone value >1 nanomole/liter [nmol/L] (0. 29 gram/mL [g/mL]) for boys For girls > 9 years and Tanner breast development stage 1: uterine size > 35 millimeter (mm)

- Severe chronic concomitant illness such as chronic renal failure, cystic fibrosis

- Concomitant corticoid treatment or levothyroxine treatment other than substitutive

treatment, topical or inhaled treatment

- Participation to any clinical study within the 30 days preceding study entry

Locations and Contacts

Additional Information

Related Info

Starting date: February 2005
Last updated: December 2, 2013

Page last updated: August 23, 2015

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