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Trial · Interventional

CompletedPhase 4Results postedRegistry data

Predictive Markers in Chinese Growth Hormone Deficiency (GHD) Children Treated With Saizen®

NCTNCT01187550 (opens ClinicalTrials.gov in a new tab)Other id27709
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
214 participants (actual)
Sponsor
Merck KGaA, Darmstadt, Germany · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
Not stated
Start
Mar 2007
Primary completion
Sept 2008
Completion
Apr 2009
First posted
24 Aug 2010 (estimated)
Last update posted
13 Feb 2014 (estimated)
Conditions
Dwarfism, Pituitary

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2007200820092010
  1. Ph 4

    Predictive Markers in Chinese Growth Hormone Deficiency (GHD) Children Treated With Saizen®

    NCT01187550

    Mar 2007 to Apr 2009

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This is an open-label, prospective, multicentric, non-comparative, non-randomized Phase IV interventional study in which subjects pre-diagnosed with Growth Hormone Deficiency (GHD) were treated for 4 weeks with Saizen to compare the response between GHD children born appropriate for gestational age (AGA) and those born small for gestation age (SGA) after 4 weeks of Saizen therapy.

Interventions

  • Recombinant human growth hormone (r-hGH)Drug

Arms0

The registry lists no arms for this trial.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change From Baseline in Serum Insulin Like Growth Factor-1 Standard Deviation Score (IGF-1 SDS) Levels at Week 4

    Time frame · Baseline and Week 4

    Registry description

    Insulin Like Growth Factor-1 Standard Deviation Score (IGF-1 SDS) was calculated as logarithm (log) 10 actual value of IGF-1 - log 10 (mean reference value of IGF-1) divided by log10 reference standard deviation of IGF-1.

Secondary outcomes(5)

  1. Change From Baseline in Insulin Like Growth Factor Binding Protein-3 (IGFBP-3) Levels at Week 4

    Time frame · Baseline and Week 4

  2. Change From Baseline in Fasting Glucose at Week 4

    Time frame · Baseline and Week 4

  3. Change From Baseline in Fasting Insulin at Week 4

    Time frame · Baseline and Week 4

  4. Change From Baseline in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) Test at Week 4

    Time frame · Baseline and Week 4

    Registry description

    HOMA-IR is used to assess insulin resistance and calculated by an empirical mathematical formula based on fasting plasma glucose and fasting plasma insulin levels. HOMA-IR = fasting plasma insulin (picomole/liter \[pmol/L\]) \* fasting plasma glucose (millimole/liter \[mmol/L\]) divided by 22.5.

  5. Change From Baseline in Lipid Profile at Week 4

    Time frame · Baseline and Week 4

    Registry description

    Total cholesterol, high-density lipoprotein (HDL)-cholesterol, low-density lipoprotein (LDL)-cholesterol and triglycerides levels were evaluated.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Baseline and Week 4

Change From Baseline in Serum Insulin Like Growth Factor-1 Standard Deviation Score (IGF-1 SDS) Levels at Week 4

GroupValue (nanogram/millilter (ng/mL))Spread
Appropriate for Gestational Age (AGA)-2.042.341
Small for Gestational Age (SGA)-2.222.390
Secondary and other outcome results(5)
Secondary outcomeMean· Baseline and Week 4

Change From Baseline in Insulin Like Growth Factor Binding Protein-3 (IGFBP-3) Levels at Week 4

GroupValue (microgram/mL (mcg/mL))Spread
Appropriate for Gestational Age (AGA)3.161.386
Small for Gestational Age (SGA)2.571.525
Secondary outcomeMean· Baseline and Week 4

Change From Baseline in Fasting Glucose at Week 4

GroupValue (millimole/liter (mmol/L))Spread
Appropriate for Gestational Age (AGA)4.830.471
Small for Gestational Age (SGA)4.461.106
Secondary outcomeMean· Baseline and Week 4

Change From Baseline in Fasting Insulin at Week 4

GroupValue (picomole/L (pmol/L))Spread
Appropriate for Gestational Age (AGA)36.1774.575
Small for Gestational Age (SGA)23.5814.892
Secondary outcomeMean· Baseline and Week 4

Change From Baseline in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) Test at Week 4

GroupValue (pmol/L*mmol/L)Spread
Appropriate for Gestational Age (AGA)7.9115.662
Small for Gestational Age (SGA)5.063.290
Secondary outcomeMean· Baseline and Week 4

Change From Baseline in Lipid Profile at Week 4

GroupValue (mmol/L)Spread
Appropriate for Gestational Age (AGA)4.160.752
Small for Gestational Age (SGA)4.220.833

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Appropriate for Gestational Age (AGA)Participants in AGA group received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (sc) at the daily dose of 0.033 milligram/kilogram (mg/kg) body weight for 4 weeks.–1 / 17527 / 175
Small for Gestational Age (SGA)Participants in SGA group received Saizen (r-hGH) sc at the daily dose of 0.033 mg/kg body weight for 4 weeks.–0 / 303 / 30

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
Not stated
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Male and female subjects with documented pre-established diagnosis of GHD with a GH peak response of \<10 microgram/liter (mcg/L) with 2 GH stimulation tests, without priming with estradiol * Subjects with SGA defined as birth weight and/or length at least 2 standard deviations (SDs) below the mean for gestational age * Subjects with prepubertal status according to Tanner * Subjects with pre-established history of normal thyroid function or adequate substitution for at least 3 months * Subjects with weight for stature within the population specific normal range (\>5th and \<95th percentiles) for gender * Subjects with willingness and ability to comply with the protocol for the duration of the study * Subjects whose parents or guardians written informed consent given before any study-related procedure that was not part of the subjects normal medical care, with the understanding that the subject or parent/guardian might withdraw consent at any time without prejudice to future medical care. If the child was old enough to read and write, a separate assent form was given Exclusion Criteria: * Subjects who acquired GHD due to central nervous system tumor, trauma, infection, infiltration (documented by imaging), and history of irradiation or cranial surgery * Subjects with previous treatment with GH, growth hormone releasing hormone (GHRH), anabolic steroids or any treatment affecting growth * Subjects who had previous treatment with corticosteroids, except in case of topical or inhaled corticosteroid administration for atopic disease. Corticosteroids for hormonal substitution were also allowed if the condition and the treatment regimen had been stable for at least 3 months * Subjects with severe associated pathology affecting growth such as malnutrition, malabsorption, or bone dysplasia * Subjects with chronic severe kidney disease * Subjects with chronic severe liver disease * Subjects with chronic infectious disease * Subjects with acute or severe illness during the previous 6 months * Subjects with significant concomitant illness that would interfere with participation or assessment in this study * Subjects who had active malignancy (except non-melanomatous skin malignancies that had undergone surgical excision and/or biopsy, diagnosis and treatment to resolution) * Subjects with history or active idiopathic intra-cranial hypertension (benign intracranial hypertension or pseudo-tumor cerebri) * Subjects with diabetes mellitus type I \& II * Subjects with any autoimmune disease * Subjects who had previous screening failure in this study * Subjects who had used an investigational drug or participated in another clinical study within the last 3 months

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