Dwarfism, PituitaryNCT06587035
A Study to Learn About Somatrogon in Patients With Pediatric Growth Hormone Deficiency (p GHD) in India.
An observational study of Dwarfism, Pituitary, run by Pfizer at 4 sites in India.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Dwarfism, Pituitary
- What is being tested?
- Somatrogon
- How many people
- 50 participants
- Where
- 4 sitesIndia
- Study dates
- 30 Jan 2025to 5 Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: 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).
Who may be able to join
- Prescription of Somatrogon for p GHD in participants aged 3 years or more.
- Evidence of a personally signed and dated informed consent document indicating that the participant (or a legally acceptable representative) has been informed and agree to all pertinent aspects of the study. Assent will also be sought from children of applicable age in line with national guidance. In all cases, the treating physician responsible for enrolling the participant into the study will assess the appropriateness of gaining assent from a participant (or a legally acceptable representative) at their discretion during routine clinical care.
Who cannot join
- Participation in any interventional clinical trials at the time of enrollment.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
India4 sites, 4 recruiting
- Recruiting
Shivajoyti Clinic
Bengaluru, Karnataka, 560008
- Recruiting
Apollo Children's Hospital
Chennai, Tamil Nadu, 600006
- Recruiting
G Kuppuswamy Naidu Memorial Hospital
Coimbatore, Tamil Nadu, 641037
- Recruiting
Apollo Speciality Hospital
Madurai, Tamil Nadu, 625020
About this study
Official title: A Multicenter, Non-interventional Prospective Active Surveillance Study Among Participants Receiving Somatrogon Under Routine Clinical Care in India
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.
Read more
This study is seeking for participants who are:
- confirmed with p GHD.
- given Somatrogon to be taken as an injection.
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.
- Conditions
- Dwarfism, Pituitary
- Being tested
- Somatrogon
- Keywords
- Somatrogon, Safety
- Medical subject headings
- Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SomatrogonDrug
Long-acting growth hormone for pediatric growth hormone deficiency.
| Study group | Role | What they receive |
|---|---|---|
| Patients of pediatric growth hormone deficiency | Not described Receives: Drug: Somatrogon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events in participants on Somatrogon
Measured: 3 years
Secondary outcomes (1)
Number of participants reporting missed injections with Somatrogon in order to evaluate treatment adherence
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start30 Jan 2025
- Primary completion21 Sep 2026 (estimated)
- Study completion5 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dwarfism, PituitaryStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06587035
- Sponsor's protocol ID
- C0311026
- Other IDs
- NCT06587035
- Status last verified
- Sep 2026
- First submitted
- 4 Sep 2024
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Non-interventional Prospective Active Surveillance Study Among Participants Receiving Somatrogon Under Routine Clinical Care in India
- ClinicalTrials.gov ID
- NCT06587035
- Acronym / sponsor ID
- C0311026
- Conditions
- Dwarfism, Pituitary
- Keywords
- Somatrogon, Safety
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 30 Jan 2025 (actual)
- Primary completion
- 21 Sep 2026 (estimated)
- Study completion
- 5 Sep 2028 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- confirmed with p GHD.
- given Somatrogon to be taken as an injection.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients of pediatric growth hormone deficiency | – | Drug: Somatrogon |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 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).
Key inclusion criteria (2 listed)
- Prescription of Somatrogon for p GHD in participants aged 3 years or more.
- Evidence of a personally signed and dated informed consent document indicating that the participant (or a legally acceptable representative) has been informed and agree to all pertinent aspects of the study. Assent will also be sought from children of applicable age in line with national guidance. In all cases, the treating physician responsible for enrolling the participant into the study will assess the appropriateness of gaining assent from a participant (or a legally acceptable representative) at their discretion during routine clinical care.
Key exclusion criteria (1 listed)
- Participation in any interventional clinical trials at the time of enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SomatrogonLong-acting growth hormone for pediatric growth hormone deficiency. | Drug | Patients of pediatric growth hormone deficiency |
Primary outcome
Number of adverse events in participants on Somatrogon
Time frame: 3 years
1 secondary outcome
Number of participants reporting missed injections with Somatrogon in order to evaluate treatment adherence
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pfizer CT.gov Call Center study director
Pfizer
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dwarfism, Pituitary, run by Pfizer at 4 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adverse events in participants on Somatrogon (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.