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

Merck KGaA (EMD Serono)

Status and phase

Terminated

Phase 3

Conditions

Growth Hormone Deficiency (GHD)

Treatments

Drug: Saizen®

Study type

Interventional

Funder types

Industry

Identifiers

EMR 701048-009

Details and patient eligibility

About

To assess the immunogenicity of Saizen® solution for injection in adult subjects with documented Growth Hormone Deficiency (GHD).

Enrollment

59 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adult male and female subjects, 18-60 years of age, inclusive, at the time the informed consent is signed
Subjects who have confirmed adult GHD
Subjects who are growth hormone (GH) treatment-naive or had received Saizen® (freeze-dried formulation) for pediatric GHD (PGHD), or are currently receiving Saizen® freeze-dried formulation for adult GHD (AGHD)
Subjects who have binding antibody-negative (BAbs-) at screening
Subjects who have no evidence of concomitant disease, intercurrent illness, or resultant therapy that would interfere with subject compliance, the evaluation of study results, or compromise the safety of the subject
Female subjects of childbearing potential who have a negative serum pregnancy test at the screening visit (and at each scheduled visit during the study)
Subjects who are willing to comply with the procedures of the study
Subjects who are willing to sign an Independent Ethics Committee/Institutional Review Board approved informed consent form
Other protocol-defined inclusion criteria may apply

Exclusion criteria

Subjects who are currently receiving or have previously received treatment for adult GHD or any other indication, including PGHD, with a commercial GH product other than Saizen® freeze-dried formulation
Subjects who had a chronic underlying disease within 6 months prior to screening or concomitant medication(s) that in the opinion of the investigator would exclude the subject from the trial
Subjects who have significant renal impairment
Subjects who have diabetes mellitus
Subjects who are immunosuppressed
Subjects who have a current malignancy or a history of any malignancy (excluding fully-treated basal cell carcinoma)
Subjects who have participated in another study and received an investigational drug within 30 days prior to screening visit
Subjects who have clinically significant abnormal laboratory value(s)
Subjects who have known hypersensitivity or allergy to exogenous human GH or any of the excipients or phenol, the bacteriostatic agent in the Saizen® solution for injection
Other protocol-defined exclusion criteria may apply