Efficacy & Safety Evaluation of Recombinant Human Growth Hormone (r-hGH),

Efficacy and Safety Evaluation of Recombinant Human Growth Hormone (r-hGH), Saizen®, on a Population of Children With Hypochondroplasia, Treated at Least 3 Years or Until Near Final Height, When Applicable, in Comparison With a Historic Cohort of Non-treated Children

Hypochondroplasia Clinical Trial

Official title:
Efficacy and Safety Evaluation of Recombinant Human Growth Hormone (r-hGH), Saizen®, on a Population of Children With Hypochondroplasia, Treated Over a Period of 3 Years or 5 Years if Applicable, in Comparison With a Historic Cohort of Non-treated Children With Hypochondroplasia

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05328050` - Registry for Patients With Achondroplasia / Hypochondroplasia (OMPR-Ach/Hy)
Recruiting	`NCT06212947` - A Multicenter Multinational Observational Study of Children With Hypochondroplasia
Completed	`NCT01541306` - C-Type Natriuretic Peptide and Achondroplasia	N/A

See also

Status

Clinical Trial

Phase

Recruiting

NCT05328050 - Registry for Patients With Achondroplasia / Hypochondroplasia (OMPR-Ach/Hy)

Recruiting

NCT06212947 - A Multicenter Multinational Observational Study of Children With Hypochondroplasia

Completed

NCT01541306 - C-Type Natriuretic Peptide and Achondroplasia

N/A

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT01111019
Study type	Interventional
Source	Merck KGaA, Darmstadt, Germany
Contact
Status	Completed
Phase	Phase 2
Start date	March 21, 2006
Completion date	January 17, 2017

Efficacy and Safety Evaluation of Recombinant Human Growth Hormone (r-hGH), Saizen®, on a Population of Children With Hypochondroplasia, Treated at Least 3 Years or Until Near Final Height, When Applicable, in Comparison With a Historic Cohort of Non-treated Children

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms