A Study to Learn About Somatrogon in Patients With Pediatric Growth Hormone Deficiency (p GHD) in India.

NCT06587035 | Recruiting FDA Drug

• 2 other identifiers: C0311026NCT06587035
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 4

Brief 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. 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.

Conditions

Dwarfism, Pituitary

Keywords

Somatrogon, Safety

Outcome Measures

Primary Outcomes (1)

• Number of adverse events in participants on Somatrogon

  3 years

Secondary Outcomes (1)

• Number of participants reporting missed injections with Somatrogon in order to evaluate treatment adherence

  3 years

Study Arms (1)

Patients of pediatric growth hormone deficiency

Drug: Somatrogon

Interventions

Somatrogon DRUG

Long-acting growth hormone for pediatric growth hormone deficiency.

Patients of pediatric growth hormone deficiency

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

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).

You may qualify if:

• 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.

You may not qualify if:

• Participation in any interventional clinical trials at the time of enrollment.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (4)

Shivajoyti Clinic

Bengaluru, Karnataka, 560008, India

RECRUITING

Apollo Children's Hospital

Chennai, Tamil Nadu, 600006, India

RECRUITING

G Kuppuswamy Naidu Memorial Hospital

Coimbatore, Tamil Nadu, 641037, India

RECRUITING

Apollo Speciality Hospital

Madurai, Tamil Nadu, 625020, India

RECRUITING

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Dwarfism, Pituitary

Interventions

somatrogon

Condition Hierarchy (Ancestors)

Dwarfism; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Endocrine; Hypopituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: September 19, 2024
• Study Start: January 30, 2025
• Primary Completion (Estimated): September 21, 2026
• Study Completion (Estimated): September 5, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

IN (4)