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| ID | Type | Description | Link |
|---|---|---|---|
| NCT06587035 | Registry Identifier | ClinicalTrials.gov |
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The purpose of this study is to learn about the safety of Somatrogon for the treatment of pediatric growth hormone deficiency (p GHD) in India.
Pediatric GHD is a condition caused by too less amounts of growth hormone in the body. Children with GHD have a short height. GHD can be present at birth or develop later. The condition occurs if the pituitary gland makes too little growth hormone. This is a small gland at the bottom of the brain that releases hormones that affect growth and other body functions.
This study is seeking for participants who are:
The safety of Somatrogon injection will be checked based on side effects. These side effects can happen within 3 years after taking Somatrogon. A side effect is something (expected or unexpected) that you feel was caused by a medicine or treatment you take. The study doctor will collect side effect information and put the information on patient's case form.
Follow-up of the patient's will be performed via clinic re-visit or over a call. It is not a rule for the participants to visit the clinic in this study.
This study will help to see if Somatrogon is safe.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients of pediatric growth hormone deficiency |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Somatrogon | Drug | Long-acting growth hormone for pediatric growth hormone deficiency. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events in participants on Somatrogon | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants reporting missed injections with Somatrogon in order to evaluate treatment adherence | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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Participants treated with Somatrogon will be followed by the treating physician as per routine clinical practice, who will collect and enter relevant participant data onto case report forms (CRFs).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pfizer CT.gov Call Center | Contact | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shivajoyti Clinic | Recruiting | Bengaluru | Karnataka | 560008 | India | |
| Apollo Children's Hospital |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| 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 |
|---|---|
| C000723339 | somatrogon |
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| Recruiting |
| Chennai |
| Tamil Nadu |
| 600006 |
| India |
| G Kuppuswamy Naidu Memorial Hospital | Recruiting | Coimbatore | Tamil Nadu | 641037 | India |
| Apollo Speciality Hospital | Recruiting | Madurai | Tamil Nadu | 625020 | India |
| 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 |