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The Sponsor voluntarily terminated this trial because compliance to strict Good Clinical Practice (GCP) requirements was not ensured - No safety concerns
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To assess the immunogenicity of Saizen® solution for injection in adult subjects with documented Growth Hormone Deficiency (GHD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saizen® | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saizen® | Drug | Single dose of Saizen® (recombinant human growth hormone, r-hGH) solution for injection will be administered subcutaneously for 26 weeks. Dosage regimen will be in accordance with marketed formulation of Saizen® (freeze-dried formulation), based on locally approved product labeling. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Developed Positive Binding Antibodies (BAbs+) to Saizen® | Binding antibodies (BAbs) are all antibodies which are capable of binding to the investigational drug molecule (Saizen®), irrespective of their binding site. | Baseline up to Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Developed Positive Neutralizing Antibodies (NAbs+) to Saizen® | Neutralizing antibodies (NAbs) are defined as a subgroup of BAbs which bind to the active sites of the investigational drug molecule (Saizen®) and therefore neutralize its potency. | Baseline up to Week 26 |
| Insulin-like Growth Factor-I (IGF-1) Levels |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck Serono S.A., Geneva | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| US Medical Information | Massachusetts | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Saizen® | Single dose of Saizen® (recombinant human growth hormone, r-hGH) solution for injection will be administered subcutaneously for 26 weeks. Dosage regimen will be in accordance with marketed formulation of Saizen® (freeze-dried formulation), based on locally approved product labeling. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Saizen® | Single dose of Saizen® (recombinant human growth hormone, r-hGH) solution for injection will be administered subcutaneously for 26 weeks. Dosage regimen will be in accordance with marketed formulation of Saizen® (freeze-dried formulation), based on locally approved product labeling. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 | Number of Participants Who Developed Positive Binding Antibodies (BAbs+) to Saizen® | Binding antibodies (BAbs) are all antibodies which are capable of binding to the investigational drug molecule (Saizen®), irrespective of their binding site. | Modified Intent-to-Treat (MITT) population consisted of all the participants who received at least 1 dose of study medication and had at least one post-baseline BAbs assessment. | Posted | Number | participants | Baseline up to Week 26 |
|
Day 1 up to 28 days after last dose of study treatment
TEAEs: AEs occurring after the first administration of Saizen® solution for injection (on Day 1) up to the scheduled routine post treatment follow-up visit (4 weeks [28 days] after the final administration of Saizen® solution for injection).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Saizen® | Single dose of Saizen® (recombinant human growth hormone, r-hGH) solution for injection will be administered subcutaneously for 26 weeks. Dosage regimen will be in accordance with marketed formulation of Saizen® (freeze-dried formulation), based on locally approved product labeling. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anxiety | Psychiatric disorders | MedDRA (14.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oedema peripheral | General disorders | MedDRA (14.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Merck KGaA Communication Center | Merck Serono, a division of Merck KGaA | +49-6151-72-5200 | service@merckgroup.com |
Not provided
| ID | Term |
|---|---|
| D004393 | Dwarfism, Pituitary |
| ID | Term |
|---|---|
| D004392 | Dwarfism |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D019382 | Human Growth Hormone |
| ID | Term |
|---|---|
| D013006 | Growth Hormone |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
Not provided
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|
|
| Baseline, Week 2, Week 4, Week 8, Week 13, Week 18, Week 26 |
| Insulin-like Growth Factor-I Standard Deviation Score (IGF-1 SDS) | Insulin-like Growth Factor-1 Standard Deviation Score (IGF-1 SDS) was provided by the central laboratory; its calculation is based on the actual value of IGF-1 minus mean reference value of IGF-1 divided by reference standard deviation of IGF-1. | Baseline, Week 2, Week 4, Week 8, Week 13, Week 18, Week 26 |
| Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels | Baseline, Week 2, Week 4, Week 8, Week 13, Week 18, Week 26 |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Adverse events (AEs): Any untoward medical occurrence in the form of signs, clinically significant abnormalities in laboratory findings, diseases, symptoms, or worsening of complications. TEAEs: AEs occurring after the first administration of Saizen® solution for injection (on Day 1) up to the scheduled routine post treatment follow-up visit (4 weeks [28 days] after the final administration of Saizen® solution for injection). | Day 1 up to 28 days after last dose of study treatment |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Number of Participants Who Developed Positive Neutralizing Antibodies (NAbs+) to Saizen® | Neutralizing antibodies (NAbs) are defined as a subgroup of BAbs which bind to the active sites of the investigational drug molecule (Saizen®) and therefore neutralize its potency. | MITT population consisted of all the participants who received at least 1 dose of study medication and had at least one post-baseline BAbs assessment. | Posted | Number | participants | Baseline up to Week 26 |
|
|
|
| Secondary | Insulin-like Growth Factor-I (IGF-1) Levels | Safety population consisted of all the participants who received at least 1 dose of study medication and had at least one post-baseline safety assessment. 'N' (number of participants analyzed) = participants who were evaluated for this measure and "n"= participants who were analyzed at that particular time point for each arm group respectively. | Posted | Mean | Standard Deviation | nanomole per liter (nmol/L) | Baseline, Week 2, Week 4, Week 8, Week 13, Week 18, Week 26 |
|
|
|
| Secondary | Insulin-like Growth Factor-I Standard Deviation Score (IGF-1 SDS) | Insulin-like Growth Factor-1 Standard Deviation Score (IGF-1 SDS) was provided by the central laboratory; its calculation is based on the actual value of IGF-1 minus mean reference value of IGF-1 divided by reference standard deviation of IGF-1. | Safety population consisted of all the participants who received at least 1 dose of study medication and had at least one post-baseline safety assessment. 'N' (number of participants analyzed) = participants who were evaluated for this measure and "n"= participants who were analyzed at that particular time point for each arm group respectively. | Posted | Mean | Standard Deviation | standard deviation score | Baseline, Week 2, Week 4, Week 8, Week 13, Week 18, Week 26 |
|
|
|
| Secondary | Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels | Safety population consisted of all the participants who received at least 1 dose of study medication and had at least one post-baseline safety assessment. Here "n" signifies number of participants analyzed at that particular time point for each arm group respectively. | Posted | Mean | Standard Deviation | nmol/L | Baseline, Week 2, Week 4, Week 8, Week 13, Week 18, Week 26 |
|
|
|
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Adverse events (AEs): Any untoward medical occurrence in the form of signs, clinically significant abnormalities in laboratory findings, diseases, symptoms, or worsening of complications. TEAEs: AEs occurring after the first administration of Saizen® solution for injection (on Day 1) up to the scheduled routine post treatment follow-up visit (4 weeks [28 days] after the final administration of Saizen® solution for injection). | Safety population consisted of all the participants who received at least 1 dose of study medication and had at least one post-baseline safety assessment. | Posted | Number | participants | Day 1 up to 28 days after last dose of study treatment |
|
|
|
| 3 |
| 59 |
| 13 |
| 59 |
| Depression | Psychiatric disorders | MedDRA (14.0) | Non-systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA (14.0) | Non-systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (14.0) | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (14.0) | Non-systematic Assessment |
|
| Insulin-like growth factor increased | Investigations | MedDRA (14.0) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Non-systematic Assessment |
|
Not provided
| 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 |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| Week 4 (n = 49, 8) |
|
| Week 8 (n = 49, 8) |
|
| Week 13 (n = 46, 8) |
|
| Week 18 (n = 31, 4) |
|
| Week 26 (n = 48, 8) |
|
| Week 4 (n = 49, 8) |
|
| Week 8 (n = 49, 8) |
|
| Week 13 (n = 46, 8) |
|
| Week 18 (n = 31, 4) |
|
| Week 26 (n = 48, 8) |
|
| Week 4 (n = 49, 8) |
|
| Week 8 (n = 50, 8) |
|
| Week 13 (n = 47, 8) |
|
| Week 18 (n = 32, 4) |
|
| Week 26 (n = 49, 8) |
|