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| ID | Type | Description | Link |
|---|---|---|---|
| ML01311 | Other Identifier | Hoffmann-La Roche |
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The study was closed due to the slow enrollment rate.
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This is a Phase IV, open label, case-controlled, observational study to evaluate the age-adjusted cumulative height velocity in pre-pubertal isolated growth hormone deficient (IGHD) and idiopathic short stature (ISS) participants receiving daily doses of somatropin (recombinant human growth hormone [rhGH]; Nutropin) using NuSpin device compared to historical controls from the national cooperative growth study (NCGS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: IGHD participants | Isolated growth hormone deficient (IGHD) participants who initiated somatropin (Deoxyribonucleic acid [DNA] origin) (recombinant human growth hormone [rhGH]) using the NuSpin device, will be observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen will be as per treating physician's discretion, the study protocol does not enforce or specify any treatment regimen. |
| |
| Cohort 2: ISS participants | Idiopathic short stature (ISS) participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, will be observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen will be as per treating physician's discretion, the study protocol does not enforce or specify any treatment regimen. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NuSpin | Device | Device for administration of doses of somatropin. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Annualized Height Velocity in Response to rhGH Treatment Using the NuSpin Device After Two Years of Treatment | The annualized height velocity (cm per year [cm/yr]) over 2 years was calculated as: [(height in cm at t24 minus (-) height in cm at t0) divided by (date at t24 - date at t0)] multiplied by 365.25, where, t0 is the baseline measurement visit and t24 is the 2-year measurement visit. | Baseline up to Month 24 (Year 2) |
| Measure | Description | Time Frame |
|---|---|---|
| Annualized Height Velocity in Response to rhGH Treatment Using the NuSpin Device for First Year of Treatment | The annualized height velocity (cm/yr) after 1 year was calculated as: [(height in cm at t12 - height in cm at t0) divided by (date at t12 - date at t0)] multiplied by 365.25, where, t0 is the baseline measurement visit and t12 is the 1-year measurement visit. | Baseline up to Month 12 (Year 1) |
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Inclusion Criteria:
Exclusion Criteria:
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Somatropin-naive pre-pubertal participants with growth hormone deficiency or ISS
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| Name | Affiliation | Role |
|---|---|---|
| D. Aaron Davis, M.D. | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35233 | United States | |||
Due to slow enrollment, the study was terminated after screening 33 participants and enrolling only 18 participants, out of 480 planned participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | IGHD Participants | Isolated growth hormone deficient (IGHD) participants who initiated somatropin (Deoxyribonucleic acid [DNA] origin) (recombinant human growth hormone [rhGH]) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician's discretion, the study protocol did not enforce or specified any treatment regimen. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Somatropin | Drug | Somatropin using either NuSpin or Nutropin AQ Pen, as per standard dosing. |
|
|
| Annualized Height Velocity in Response to rhGH Treatment Using the NuSpin Device During the Second Year of Therapy | The annualized height velocity (cm/yr) for second year was calculated as: [(height in cm at t24 - height in cm at t12) divided by (date at t24 - date at t12)] multiplied by 365.25, where, t12 is the 1-year measurement visit and t24 is the 2-year measurement visit. | Month 12 to Month 24 (Year 1 to Year 2) |
| Scottsdale |
| Arizona |
| 85258 |
| United States |
| Sacramento | California | 95819 | United States |
| San Diego | California | 92123 | United States |
| Greenwood Village | Colorado | 80111 | United States |
| Palm Bay | Florida | 32905 | United States |
| Pembrook Pines | Florida | 33028 | United States |
| Atlanta | Georgia | 30342 | United States |
| Wheaton | Illinois | 60187 | United States |
| Minneapolis | Minnesota | 55455 | United States |
| Mount Kisco | New York | 10549 | United States |
| New Rochelle | New York | 10801 | United States |
| Columbus | Ohio | 43235 | United States |
| Knoxville | Tennessee | 37916 | United States |
| FG001 | ISS Participants | Idiopathic short stature (ISS) participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician's discretion, the study protocol did not enforce or specified any treatment regimen. |
| COMPLETED |
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| NOT COMPLETED |
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Study population included all enrolled somatropin-naive pre-pubertal participants with growth hormone deficiency or ISS.
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| ID | Title | Description |
|---|---|---|
| BG000 | IGHD Participants | IGHD participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician's discretion, the study protocol did not enforce or specified any treatment regimen. |
| BG001 | ISS Participants | ISS participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician's discretion, the study protocol did not enforce or specified any treatment regimen. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Annualized Height Velocity in Response to rhGH Treatment Using the NuSpin Device After Two Years of Treatment | The annualized height velocity (cm per year [cm/yr]) over 2 years was calculated as: [(height in cm at t24 minus (-) height in cm at t0) divided by (date at t24 - date at t0)] multiplied by 365.25, where, t0 is the baseline measurement visit and t24 is the 2-year measurement visit. | Data for this outcome measure was not collected as the study was terminated prematurely due to slow enrollment. | Posted | Baseline up to Month 24 (Year 2) |
|
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| Secondary | Annualized Height Velocity in Response to rhGH Treatment Using the NuSpin Device for First Year of Treatment | The annualized height velocity (cm/yr) after 1 year was calculated as: [(height in cm at t12 - height in cm at t0) divided by (date at t12 - date at t0)] multiplied by 365.25, where, t0 is the baseline measurement visit and t12 is the 1-year measurement visit. | Data for this outcome measure was not collected as the study was terminated prematurely due to slow enrollment. | Posted | Baseline up to Month 12 (Year 1) |
|
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| Secondary | Annualized Height Velocity in Response to rhGH Treatment Using the NuSpin Device During the Second Year of Therapy | The annualized height velocity (cm/yr) for second year was calculated as: [(height in cm at t24 - height in cm at t12) divided by (date at t24 - date at t12)] multiplied by 365.25, where, t12 is the 1-year measurement visit and t24 is the 2-year measurement visit. | Data for this outcome measure was not collected as the study was terminated prematurely due to slow enrollment. | Posted | Month 12 to Month 24 (Year 1 to Year 2) |
|
Baseline up to approximately 9 months
Study population included all enrolled somatropin-naive pre-pubertal participants with growth hormone deficiency or ISS.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IGHD Participants | IGHD participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician's discretion, the study protocol did not enforce or specified any treatment regimen. | 1 | 15 | 0 | 15 | ||
| EG001 | ISS Participants | ISS participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician's discretion, the study protocol did not enforce or specified any treatment regimen. | 0 | 3 | 1 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Peripheral oedema | General disorders | MedDRA (19.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
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The study was terminated prematurely due to slow enrollment.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D004393 | Dwarfism, Pituitary |
| ID | Term |
|---|---|
| D004392 | Dwarfism |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001849 | Bone Diseases, Endocrine |
| D007018 | Hypopituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D019382 | Human Growth Hormone |
| D013006 | Growth Hormone |
| D007267 | Injections |
| ID | Term |
|---|---|
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| Male |
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| Participants |
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| Units |
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| Counts |
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| Participants |
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