ClinicalTrials.gov
ClinicalTrials.gov Menu

Predictive Markers in Growth Hormone Deficiency (GHD) and Turner Syndrome (TS) Children Treated With SAIZEN®

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00256126
Recruitment Status : Completed
First Posted : November 21, 2005
Results First Posted : March 20, 2018
Last Update Posted : March 20, 2018
Sponsor:
Information provided by (Responsible Party):
Merck KGaA

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Growth Hormone Deficiency
Turner Syndrome
Intervention: Drug: Saizen

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First informed consent date: Dec 2013. Clinical data cutoff date: Oct 2007, Study completion date: Sep 2007.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 319 subjects were screened for this trial. Only 1 subject withdrew from the study prior to receiving the treatment due to personal reasons. Overall, 318 subjects were enrolled into the study.

Reporting Groups
  Description
Turner Syndrome (TS) Subjects with TS were administered with SAIZEN® as subcutaneous injection at a dose of 0.050 milligram per kilogram (mg/kg) of body weight per day (within the recommended dosage 0.045-0.050 mg/kg body weight) for a period of 1 month.
Growth Hormone Deficiency (GHD) Subjects with GHD were administered with SAIZEN® as subcutaneous injection at a dose of 0.035 mg/kg of body weight per day (within the recommended dosage 0.025-0.035 mg/kg body weight) for a period of 1 month.

Participant Flow:   Overall Study
    Turner Syndrome (TS)   Growth Hormone Deficiency (GHD)
STARTED   149   169 
COMPLETED   147   167 
NOT COMPLETED   2   2 
Adverse Event                1                0 
Other                1                2 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Turner Syndrome (TS) Subjects with TS were administered with SAIZEN® as subcutaneous injection at a dose of 0.050 milligram per kilogram (mg/kg) of body weight per day (within the recommended dosage 0.045-0.050 mg/kg body weight) for a period of 1 month.
Growth Hormone Deficiency (GHD) Subjects with GHD were administered with SAIZEN® as subcutaneous injection at a dose of 0.035 mg/kg of body weight per day (within the recommended dosage 0.025-0.035 mg/kg body weight) for a period of 1 month.
Total Total of all reporting groups

Baseline Measures
   Turner Syndrome (TS)   Growth Hormone Deficiency (GHD)   Total 
Overall Participants Analyzed 
[Units: Participants]
 149   169   318 
Age 
[Units: Years]
Mean (Standard Deviation)
 9.3  (4.08)   8.94  (3.17)   9.11  (3.62) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      149 100.0%      63  37.3%      212  66.7% 
Male      0   0.0%      106  62.7%      106  33.3% 


  Outcome Measures

1.  Primary:   Change From Baseline in Insulin Like Growth Factor-1 Standard Deviation Score (IGF-1 SDS) at Month 1   [ Time Frame: Baseline, Month 1 ]

2.  Secondary:   Change From Baseline in Insulin-like Growth Factor Binding Protein - 3 (IGFBP-3) Level at Month 1   [ Time Frame: Baseline, Month 1 ]

3.  Secondary:   Change From Baseline in Fasting Glucose Levels at Month 1   [ Time Frame: Baseline, Month 1 ]

4.  Secondary:   Change From Baseline in Fasting Insulin Levels at Month 1   [ Time Frame: Baseline, Month 1 ]

5.  Secondary:   Change From Baseline in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) at Month 1   [ Time Frame: Baseline, Month 1 ]

6.  Secondary:   Change From Baseline in Bone Alkaline Phosphatase Levels at Month 1   [ Time Frame: Baseline, Month 1 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Limitations of the trial were short duration of the study treatment, and relatively small sample size


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Merck KGaA Communication Center
Organization: Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany
phone: +49-6151-72-5200
e-mail: service@merckgroup.com


Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT00256126     History of Changes
Other Study ID Numbers: 24531
First Submitted: November 18, 2005
First Posted: November 21, 2005
Results First Submitted: August 24, 2017
Results First Posted: March 20, 2018
Last Update Posted: March 20, 2018