Primary outcomeMean· Baseline to Week 24
Percent Change From Baseline to Week 24 in Trunk Fat
| Group | Value (percent change) | Spread |
|---|---|---|
| Standard Dose Group | -6.27 | 12.72 |
| High Dose Group | -8.36 | 17.69 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataCool.Click™ Adolescent Transition Study: Study of Saizen® in Subjects With Childhood-onset Growth Hormone Deficiency
NCTNCT00109733 (opens ClinicalTrials.gov in a new tab)Other id25253
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 31 participants (actual)
- Sponsor
- EMD Serono · Industry
- Design
- Randomized · Open label (no masking)
- Countries
1 country
United States
- Start
- Jan 2005
- Primary completion
- Jun 2006
- Completion
- Jul 2006
- First posted
- 3 May 2005 (estimated)
- Last update posted
- 7 Aug 2013 (estimated)
- Conditions
- Childhood-onset Growth Hormone Deficiency · Pituitary Dwarfism
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
200520062007
- Ph 3
Cool.Click™ Adolescent Transition Study: Study of Saizen® in Subjects With Childhood-onset Growth Hormone Deficiency
NCT00109733Jan 2005 to Jul 2006
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The primary objective is to evaluate the efficacy and safety of two different dose regimens of r-hGH (Saizen®) in subjects with childhood-onset growth hormone deficiency (COGHD) during the transition phase from childhood to adulthood.
Interventions
- recombinant human growth hormoneBiological
- recombinant human growth hormoneBiological
Arms2
Experimental
Standard dose group
0.005 mg/kg/day recombinant human growth hormone (r-hGH) for 30 days then increasing, with the Investigator's approval, to 0.010 mg/kg/day from Day 31 to Week 24.
Experimental
High dose group
0.010 mg/kg/day recombinant human growth hormone for 14 days with the opportunity to dose escalate, with the Investigator's approval, on Day 15 to 0.02 mg/kg/day and Day 29 to 0.03 mg/kg/day.
Primary outcomes1
Outcomes the sponsor listed as primary.
Percent Change From Baseline to Week 24 in Trunk Fat
Time frame · Baseline to Week 24
Secondary outcomes(4)
Percent Change From Baseline to Week 24 in Lean Body Mass
Time frame · Baseline to Week 24
Percent Change From Baseline to Week 24 in Total Body Fat
Time frame · Baseline to Week 24
Percent Change From Baseline to Week 24 in Limb Fat
Time frame · Baseline to Week 24
Percent Change From Baseline to Week 24 in Trunk to Limb Fat Ratio
Time frame · Baseline to Week 24
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(4)
Secondary outcomeMean· Baseline to Week 24
Percent Change From Baseline to Week 24 in Lean Body Mass
| Group | Value (percent change) | Spread |
|---|---|---|
| Standard Dose Group | 3.85 | 4.05 |
| High Dose Group | 7.10 | 5.02 |
Secondary outcomeMean· Baseline to Week 24
Percent Change From Baseline to Week 24 in Total Body Fat
| Group | Value (percent change) | Spread |
|---|---|---|
| Standard Dose Group | -4.62 | 9.96 |
| High Dose Group | -9.69 | 10.54 |
Secondary outcomeMean· Baseline to Week 24
Percent Change From Baseline to Week 24 in Limb Fat
| Group | Value (percent change) | Spread |
|---|---|---|
| Standard Dose Group | -3.77 | 8.85 |
| High Dose Group | -11.09 | 8.97 |
Secondary outcomeMean· Baseline to Week 24
Percent Change From Baseline to Week 24 in Trunk to Limb Fat Ratio
| Group | Value (percent change) | Spread |
|---|---|---|
| Standard Dose Group | -2.86 | 6.77 |
| High Dose Group | 2.92 | 16.16 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Standard Dose Group0.005 mg/kg/day recombinant human growth hormone(r-hGH)for 30 days then increasing, with the Investigator's approval, to 0.010 mg/kg/day from Day 31 to Week 24. | – | 0 / 15 | 13 / 15 |
| High Dose Group0.010 mg/kg/day recombinant human growth hormone for 14 days with the opportunity to dose escalate, with the Investigator's approval, on Day 15 to 0.02 mg/kg/day and Day 29 to 0.03 mg/kg/day. | – | 1 / 16 | 14 / 16 |
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
- from 13 Years up to 25 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
The day of entry or Study Day 1 is defined as the first day of study treatment. To be eligible for inclusion into this study, the subjects must fulfill all of the following criteria within 30 days prior to Study Day 1.
* Male or female from 13 to 25 years of age, inclusive
* Diagnosis of childhood onset growth hormone deficiency (GHD) and prior completed growth hormone (GH) treatment as evidenced by bone age greater than 14 years for girls and 16 years for boys or no height increase \> 0.5 cm in the 6 months prior to Screen.
* Have documented GH deficiency (acquired or idiopathic), established by a standard provocative test, such as insulin (\<5 ng/mL) or growth hormone releasing hormone plus arginine (\<9 ng/mL) at least 30 days after GH has been discontinued. If a subject is hypopituitary with two or more pituitary disorders and has a low IGF-1, the stimulation test does not need to be performed to confirm GHD.
* If hypopituitary, must have been on adequate replacement therapy (if required) of glucocorticosteroids, thyroid and sex hormones (hormone levels on replacement being in normal/mildly elevated range) for at least 6 months prior to Screen.
* Be willing and able to comply with the protocol for the duration of the study.
* Have given written informed consent before any study-related procedure not part of the subject's normal medical care, with the understanding that the subject may withdraw consent at any time without prejudice to future medical care.
* Female subjects of childbearing potential must use a hormonal contraceptive, intra-uterine device, diaphragm with spermicide or condom with spermicide for the duration of the study. Confirmation that a female patient is not pregnant must be established by a negative human chorionic gonadotrophin (hCG) pregnancy test (urine or serum) within 7 days of study enrolment (SD1).
Exclusion Criteria:
To be eligible for inclusion in this study the subjects must not meet any of the following criteria:
* Known allergy or hypersensitivity to growth hormone or diluent.
* Previous treatment with GH within six months prior to Screen.
* Severe illness during the previous six months.
* Active malignancy (except non-melanomatous skin malignancies).
* Diabetes mellitus (type I or II).
* Seropositivity for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HbsAg) and/or Hepatitis C Virus (HCV) serology.
* Pregnancy or lactation.
* History of drug and/or alcohol abuse or use of drugs for non-therapeutic purposes.
* Any medical condition that, in the opinion of the Investigator, would jeopardize the patient's safety following exposure to study drug.
* Clinically significant abnormal hematology, chemistry or urinalysis results at screening in the judgment of the Investigator.
* Have taken another investigational drug or had any experimental procedure in the six months preceding study entry.
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