Trial · NCT01067352
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)
NCT01067352, Phase 3, Terminated, Merck KGaA, Darmstadt, Germany; results first posted 2011-12-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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). Trials, record NCT01067352. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01067352
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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)
- NCT number
- NCT01067352
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 25 participants, actual
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Conditions
- Infant, Small for Gestational Age
- Interventions
- Recombinant human growth hormone (r-hGH)
- First posted
- 2010-02-11
- Last updated
- 2013-12-27
- Results first posted
- 2011-12-14
- Limitations and caveats
- 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).
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Correlation Between Gene Expression Profiling and Catch-up Growth in Small for Gestational Age (SGA) Children | Baseline and Week 48 | Gene expression profiling:analysis of ribonucleic acid (RNA) extracted from body tissue or fluids using Clontech Atlas Human Array to study level of activation of genes in tissue analyzed. Analysis was performed to identify possible correlation between catch-up growth (either spontaneous or drug-induced after Week 48) and therapeutic response to rhGH. Spontaneous catch up growth:shown by SGA participants having length more than third percentile at Week 96 without any treatment;drug induced growth was by SGA participants having length more than third percentile at Week 96 with drug treatment. |
| Secondary | Percentage of Untreated Participants Who Showed a Spontaneous Catch-up Growth | Baseline through Week 96 | Spontaneous catch up growth was the growth shown by SGA participants having length more than third percentile at Week 96 without any study drug treatment. |
| Secondary | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Study Drug Discontinuation | Baseline through Week 96 | AEs: any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug , SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued from the study due to AE were also recorded. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Correlation Between Gene Expression Profiling and Catch-up Growth in Small for Gestational Age (SGA) Children | Baseline and Week 48 | Gene expression profiling was not performed due to RNA degradation in nearly all of the blood samples and hence no comparison between gene expression and growth was made. | ||
| SECONDARY | Percentage of Untreated Participants Who Showed a Spontaneous Catch-up Growth | Baseline through Week 96 | Data was not analyzed due to small number of evaluable participants. | ||
| SECONDARY | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Study Drug Discontinuation | Baseline through Week 96 | Safety analysis population included all randomized participants with at least 1 post-baseline assessment. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Study Drug Discontinuation | Group A, Less Than Third Percentile (Saizen) | AEs | 6 | participants | |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Study Drug Discontinuation | Group A2, Less Than Third Percentile (No Treatment) | AEs | 4 | participants | |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Study Drug Discontinuation | Group B, More Than Third Percentile (No Treatment) | AEs | 9 | participants | |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Study Drug Discontinuation | Group A, Less Than Third Percentile (Saizen) | SAEs | 0 | participants | |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Study Drug Discontinuation | Group A2, Less Than Third Percentile (No Treatment) | SAEs | 0 | participants | |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Study Drug Discontinuation | Group B, More Than Third Percentile (No Treatment) | SAEs | 0 | participants | |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Study Drug Discontinuation | Group A, Less Than Third Percentile (Saizen) | Discontinuation due to AEs | 0 | participants | |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Study Drug Discontinuation | Group A2, Less Than Third Percentile (No Treatment) | Discontinuation due to AEs | 0 | participants | |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Study Drug Discontinuation | Group B, More Than Third Percentile (No Treatment) | Discontinuation due to AEs | 0 | participants |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group A, Less Than Third Percentile (Saizen) | 9 | |
| Overall Study | STARTED | Group A2, Less Than Third Percentile (No Treatment) | 6 | |
| Overall Study | STARTED | Group B, More Than Third Percentile (No Treatment) | 10 | |
| Overall Study | COMPLETED | Group A, Less Than Third Percentile (Saizen) | 8 | |
| Overall Study | COMPLETED | Group A2, Less Than Third Percentile (No Treatment) | 3 | |
| Overall Study | COMPLETED | Group B, More Than Third Percentile (No Treatment) | 9 | |
| Overall Study | NOT COMPLETED | Group A, Less Than Third Percentile (Saizen) | 1 | |
| Overall Study | NOT COMPLETED | Group A2, Less Than Third Percentile (No Treatment) | 3 | |
| Overall Study | NOT COMPLETED | Group B, More Than Third Percentile (No Treatment) | 1 |
Source ClinicalTrials.gov
Adverse events111
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Group A, Less Than Third Percentile (Saizen) | 1 | 8 | 1 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Group A2, Less Than Third Percentile (No Treatment) | 0 | 4 | 0 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Group B, More Than Third Percentile (No Treatment) | 0 | 10 | 0 |
| other | Microcytic anaemia | Blood and lymphatic system disorders | Group A, Less Than Third Percentile (Saizen) | 1 | 8 | 2 |
| other | Microcytic anaemia | Blood and lymphatic system disorders | Group A2, Less Than Third Percentile (No Treatment) | 0 | 4 | 0 |
| other | Microcytic anaemia | Blood and lymphatic system disorders | Group B, More Than Third Percentile (No Treatment) | 0 | 10 | 0 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Group A, Less Than Third Percentile (Saizen) | 0 | 8 | 0 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Group A2, Less Than Third Percentile (No Treatment) | 0 | 4 | 0 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Group B, More Than Third Percentile (No Treatment) | 1 | 10 | 1 |
| other | Conjunctivitis | Eye disorders | Group A, Less Than Third Percentile (Saizen) | 1 | 8 | 1 |
1 to 10 of 111Source ClinicalTrials.gov
See all 111 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group A, Less Than Third Percentile (Saizen) | ||
| Total, all-cause mortality | Group A2, Less Than Third Percentile (No Treatment) | ||
| Total, all-cause mortality | Group B, More Than Third Percentile (No Treatment) | ||
| Total, other adverse events | Group A, Less Than Third Percentile (Saizen) | 6 | 8 |
| Total, other adverse events | Group A2, Less Than Third Percentile (No Treatment) | 4 | 4 |
| Total, other adverse events | Group B, More Than Third Percentile (No Treatment) | 9 | 10 |
| Total, serious adverse events | Group A, Less Than Third Percentile (Saizen) | 0 | 8 |
| Total, serious adverse events | Group A2, Less Than Third Percentile (No Treatment) | 0 | 4 |
| Total, serious adverse events | Group B, More Than Third Percentile (No Treatment) | 0 | 10 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01067352
GET https://conductscience.org/api/trials/v1/NCT01067352/events?page=2