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Trial · Interventional

TerminatedPhase 3Results postedRegistry data

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

NCTNCT01237340 (opens ClinicalTrials.gov in a new tab)Other idEMR 701048-009
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Terminated
Phase
Phase 3
Enrollment
59 participants (actual)
Sponsor
EMD Serono · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
Oct 2010
Primary completion
Dec 2011
Completion
Dec 2011
First posted
9 Nov 2010 (estimated)
Last update posted
7 Aug 2013 (estimated)
Conditions
Growth Hormone Deficiency (GHD)

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201020112012
  1. Ph 3

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

    NCT01237340

    Oct 2010 to Dec 2011

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • Saizen®Drug

Arms1

  • Experimental

    Saizen®

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number of Participants Who Developed Positive Binding Antibodies (BAbs+) to Saizen®

    Time frame · Baseline up to Week 26

    Registry description

    Binding antibodies (BAbs) are all antibodies which are capable of binding to the investigational drug molecule (Saizen®), irrespective of their binding site.

Secondary outcomes(5)

  1. Number of Participants Who Developed Positive Neutralizing Antibodies (NAbs+) to Saizen®

    Time frame · Baseline up to Week 26

    Registry description

    Neutralizing antibodies (NAbs) are defined as a subgroup of BAbs which bind to the active sites of the investigational drug molecule (Saizen®) and therefore neutralize its potency.

  2. Insulin-like Growth Factor-I (IGF-1) Levels

    Time frame · Baseline, Week 2, Week 4, Week 8, Week 13, Week 18, Week 26

  3. Insulin-like Growth Factor-I Standard Deviation Score (IGF-1 SDS)

    Time frame · Baseline, Week 2, Week 4, Week 8, Week 13, Week 18, Week 26

    Registry description

    Insulin-like Growth Factor-1 Standard Deviation Score (IGF-1 SDS) was provided by the central laboratory; its calculation is based on the actual value of IGF-1 minus mean reference value of IGF-1 divided by reference standard deviation of IGF-1.

  4. Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels

    Time frame · Baseline, Week 2, Week 4, Week 8, Week 13, Week 18, Week 26

  5. Number of Participants With Treatment Emergent Adverse Events (TEAEs)

    Time frame · Day 1 up to 28 days after last dose of study treatment

    Registry description

    Adverse events (AEs): Any untoward medical occurrence in the form of signs, clinically significant abnormalities in laboratory findings, diseases, symptoms, or worsening of complications. TEAEs: AEs occurring after the first administration of Saizen® solution for injection (on Day 1) up to the scheduled routine post treatment follow-up visit (4 weeks \[28 days\] after the final administration of Saizen® solution for injection).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Baseline up to Week 26

Number of Participants Who Developed Positive Binding Antibodies (BAbs+) to Saizen®

GroupValue (participants)
Saizen®1
Secondary and other outcome results(5)
Secondary outcomeNumber· Baseline up to Week 26

Number of Participants Who Developed Positive Neutralizing Antibodies (NAbs+) to Saizen®

GroupValue (participants)
Saizen®0
Secondary outcomeMean· Baseline, Week 2, Week 4, Week 8, Week 13, Week 18, Week 26

Insulin-like Growth Factor-I (IGF-1) Levels

GroupValue (nanomole per liter (nmol/L))Spread
GH Treatment-Naive11.4926.694
GH Treatment-Experienced20.22510.194
Secondary outcomeMean· Baseline, Week 2, Week 4, Week 8, Week 13, Week 18, Week 26

Insulin-like Growth Factor-I Standard Deviation Score (IGF-1 SDS)

GroupValue (standard deviation score)Spread
GH Treatment-Naive-2.9142.268
GH Treatment-Experienced-0.5502.274
Secondary outcomeMean· Baseline, Week 2, Week 4, Week 8, Week 13, Week 18, Week 26

Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels

GroupValue (nmol/L)Spread
GH Treatment-Naive124.94131.899
GH Treatment-Experienced133.37536.024
Secondary outcomeNumber· Day 1 up to 28 days after last dose of study treatment

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

GroupValue (participants)
Saizen®40

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Saizen®Single dose of Saizen® (recombinant human growth hormone, r-hGH) solution for injection will be administered subcutaneously for 26 weeks. Dosage regimen will be in accordance with marketed formulation of Saizen® (freeze-dried formulation), based on locally approved product labeling.–3 / 5913 / 59

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 60 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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