A Trial to Evaluate the Correlation Between Spontaneous Catch-up Growth, Clinical Response to Saizen (Recombinant Human Growth Hormone, r-hGH) and Gene Expression Profiling in Children Small for Gestational Age (SGA) (SAIZEN in SGA)

This study has been terminated.

(This study was discontinued prematurely due to difficulty in participant recruitment.)

Sponsor:

Collaborator:

Merck Serono S.P.A., Italy

Information provided by (Responsible Party):

Merck KGaA

ClinicalTrials.gov Identifier:

NCT01067352

First received: February 10, 2010

Last updated: November 9, 2011

Last verified: November 2011

History of Changes

Results First Received: October 5, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Infant, Small for Gestational Age
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
Participants were recruited in 12 study centers in Italy from 20 Feb 2004 to 10 Jul 2009.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Group A, Less Than Third Percentile (Saizen)	Participants with less than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (s.c) at the daily dose of 0.035 milligram(mg)/kilogram(kg) for 2 years.
Group A2, Less Than Third Percentile (No Treatment)	Participants with less than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received no drug treatment for 2 years.
Group B, More Than Third Percentile (No Treatment)	Participants with more than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received no drug treatment for 2 years.

Participant Flow: Overall Study

	Group A, Less Than Third Percentile (Saizen)	Group A2, Less Than Third Percentile (No Treatment)	Group B, More Than Third Percentile (No Treatment)
STARTED	9	6	10
COMPLETED	8	3	9
NOT COMPLETED	1	3	1
Withdrawal by Subject	1	2	1
Physician Decision	0	1	0

Baseline Characteristics

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Reporting Groups

	Description
Group A, Less Than Third Percentile (Saizen)	Participants with less than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (s.c) at the daily dose of 0.035 milligram(mg)/kilogram(kg) for 2 years.
Group A2, Less Than Third Percentile (No Treatment)	Participants with less than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received no drug treatment for 2 years.
Group B, More Than Third Percentile (No Treatment)	Participants with more than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received no drug treatment for 2 years.
Total	Total of all reporting groups

Baseline Measures

	Group A, Less Than Third Percentile (Saizen)	Group A2, Less Than Third Percentile (No Treatment)	Group B, More Than Third Percentile (No Treatment)	Total
Number of Participants [units: participants]	9	6	10	25
Age [units: years] Mean ± Standard Deviation	5.7 ± 1.2	5.0 ± 0.7	5.2 ± 0.4	5.3 ± 0.9
Gender [units: participants]
Female	4	4	5	13
Male	5	2	5	12

Outcome Measures

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1. Primary:

Correlation Between Gene Expression Profiling and Catch-up Growth in Small for Gestational Age (SGA) Children [ Time Frame: Baseline and Week 48 ]

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2. Secondary:

Percentage of Untreated Participants Who Showed a Spontaneous Catch-up Growth [ Time Frame: Baseline through Week 96 ]

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3. Secondary:

Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Study Drug Discontinuation [ Time Frame: Baseline through Week 96 ]

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: No text entered.

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
The primary and secondary efficacy objectives were not met because of poor participant enrollment and no quality RNA samples obtained to evaluate (RNA degradation in nearly all of the blood samples).

Results Point of Contact:

Name/Title: Medical Responsible
Organization: Merck Serono S.p.A., Italy, an affiliate of Merck KGaA, Darmstadt, Germany
phone: +49-6151-72-5200
e-mail: service@merck.de

No publications provided

Responsible Party:	Merck KGaA
ClinicalTrials.gov Identifier:	NCT01067352 History of Changes
Other Study ID Numbers:	IMP23681
Study First Received:	February 10, 2010
Results First Received:	October 5, 2011
Last Updated:	November 9, 2011
Health Authority:	Italy: Ethics Committee

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