Saizen® Solution for Injection Adult Growth Hormone Deficiency (GHD)

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT00271518` - Treatment of Children With Insufficient Secretion of Growth Hormone	Phase 3
Completed	`NCT01947907` - Safety, PK/PD and Efficacy of ACP-001 Weekly Versus Daily hGH in Children With Growth Hormone Deficiency (GHD)	Phase 2
Completed	`NCT02500316` - Long Term Follow up Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children	Phase 2

See also

Status

Clinical Trial

Phase

Active, not recruiting

NCT00271518 - Treatment of Children With Insufficient Secretion of Growth Hormone

Phase 3

Completed

NCT01947907 - Safety, PK/PD and Efficacy of ACP-001 Weekly Versus Daily hGH in Children With Growth Hormone Deficiency (GHD)

Phase 2

Completed

NCT02500316 - Long Term Follow up Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children

Phase 2

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	NCT01237340
Study type	Interventional
Source	EMD Serono
Contact
Status	Terminated
Phase	Phase 3
Start date	October 2010
Completion date	December 2011

Saizen® Solution for Injection Adult Growth Hormone Deficiency (GHD) Immunogenicity Study

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms