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

This study has been completed.
Sponsor:
Collaborator:
Merck Serono Co., Ltd., China
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01187550
First received: August 22, 2010
Last updated: January 20, 2014
Last verified: January 2014
Results First Received: May 9, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Dwarfism, Pituitary
Intervention: Drug: Recombinant human growth hormone (r-hGH)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Out of 214 participants enrolled in the study, 1 participant could not be categorized as appropriate for gestational age (AGA) or small for gestational age (SGA) since weight and height at birth was not available.

Reporting Groups
  Description
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.
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.

Participant Flow:   Overall Study
    Appropriate for Gestational Age (AGA)     Small for Gestational Age (SGA)  
STARTED     183     30  
Treated     175     30  
COMPLETED     169     29  
NOT COMPLETED     14     1  
Protocol Violation                 3                 1  
Unspecified                 3                 0  
Randomized but not treated                 8                 0  



  Baseline Characteristics
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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
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.
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.
Total Total of all reporting groups

Baseline Measures
    Appropriate for Gestational Age (AGA)     Small for Gestational Age (SGA)     Total  
Number of Participants  
[units: participants]
  175     30     205  
Age [1]
[units: years]
Mean ± Standard Deviation
  10.52  ± 3.844     9.39  ± 4.349     10.35  ± 3.931  
Gender [2]
[units: participants]
     
Female     46     6     52  
Male     129     24     153  
[1] Out of a total of 213 participants, data for baseline measure (age) was available for only 205 participants who were treated.
[2] Out of a total of 213 participants, data for baseline measure (gender) was available for only 205 participants who were treated.



  Outcome Measures
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1.  Primary:   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 ]

2.  Secondary:   Change From Baseline in Insulin Like Growth Factor Binding Protein-3 (IGFBP-3) Levels at Week 4   [ Time Frame: Baseline and Week 4 ]

3.  Secondary:   Change From Baseline in Fasting Glucose at Week 4   [ Time Frame: Baseline and Week 4 ]

4.  Secondary:   Change From Baseline in Fasting Insulin at Week 4   [ Time Frame: Baseline and Week 4 ]

5.  Secondary:   Change From Baseline in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) Test at Week 4   [ Time Frame: Baseline and Week 4 ]

6.  Secondary:   Change From Baseline in Lipid Profile at Week 4   [ Time Frame: Baseline and Week 4 ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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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.


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
No text entered.  


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


No publications provided


Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01187550     History of Changes
Other Study ID Numbers: 27709
Study First Received: August 22, 2010
Results First Received: May 9, 2012
Last Updated: January 20, 2014
Health Authority: China: Ethics Committee