Growth FailurePhase 1NCT01034735
r-hGH Liquid Multidose Versus Freeze-dried Multidose Bioequivalence Trial
A Phase 1 study testing r-hGH liquid (Saizen) and r-hGH freeze-dried in people with Growth Failure and Growth Hormone Deficiency, run by EMD Serono at 1 site in Germany.
Trial summary
The primary objective of the trial was to assess the bioequivalence for two concentrations (5.83 mg/mL and 8 mg/mL) of the new r-hGH liquid multidose formulation using the r hGH freeze-dried multidose formulation (Saizen® 8 mg, 8.8 mg/1.51 mL) as reference. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Growth Failure, Growth Hormone Deficiency
- What is being tested?
- r-hGH liquid (Saizen) and r-hGH freeze-dried
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2008to Aug 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Main inclusion criteria:
- Male and female aged 18 to 45 years, inclusive; who are able to read, to write and to fully understand German language
- Had given written Informed Consent
- Had a body weight greater than 55 kg and a body mass index (BMI) of >20 and < or = 30 kg/m2 (BMI = weight (kg)/height (m)2)
- Had vital signs in the following normal range:
- Ear body temperature: 35.0 - 38.0°C
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- Blood pressure (BP) - after at least 3 minutes of rest, measured in the supine position:
- systolic blood pressure: 90 - 145 mmHg diastolic blood pressure : 50 - 95 mmHg Pulse rate (PR): after at least 3 minutes of rest, measured in the supine position: 40 90 bpm
- Smoked less than 10 cigarettes per day, consented to smoke less than 5 cigarettes per day during the trial period and were able to refrain from smoking during the confinement period
- Were able to communicate well with the Investigator and willing to comply with the requirements of the entire trial
- Were willing to undergo pituitary down-regulation by intravenous infusion with somatostatin for 25 hours
- If female:
- Had a negative serum pregnancy test within three weeks prior to trial start and a negative urine pregnancy test at the day before dosing
- Were pre-menopausal and using an adequate method of non-hormonal contraception (2 barrier methods, or one barrier method with spermicide, or non-hormonal intrauterine device), sexual abstinence or females with vasectomised partners during the entire trial
Who cannot join
- Main exclusion criteria:
- Any surgical or medical condition, including findings in the medical history or in the pre trial assessments, that in the opinion of the Investigator, constituted a risk or a contraindication for the participation of the subject in the trial or that could have interfered with the trial objectives, conduct or evaluation
- Had any clinically significant abnormal laboratory test results in the pre-trial safety laboratory tests or any clinically abnormal findings on the 12 leads resting electrocardiogram (ECG) that in the opinion of the Investigator may have increased the safety risk to the subject
- Had positive results for drugs of abuse or alcohol test
- Had positive results from serology examination for Hepatitis B surface antigen (HBsAg) (not due to vaccination), Hepatitis B core antibody (HBcAb) (if positive, was to be verified by test for anti-Hbc-IgM), Hepatitis C Virus (anti-HCV) and Human Immunodeficiency Virus (anti-HIV 1 and 2) at screening
- History or presence of hypertension or other significant cardiovascular abnormalities
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- History or presence of cholelithiasis
- Significant history or clinical evidence of auto-immune, gastrointestinal, haematological, hematopoietic, hepatic, neurological, pancreatic or renal disease
- History or presence of diabetes
- History or presence of tumors of the pituitary gland or hypothalamus
- Definite or suspected personal history or family history of adverse drug reaction or hypersensitivity to drugs with a similar chemical structure to somatropin or somatostatin or its excipients, use of any chronic medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I, Open Label, Randomised Three-way Cross Over, Single-centre Trial to Assess the Bioequivalence for Two Concentrations of the New r-hGH Liquid Multidose Formulation Versus the r-hGH Freeze-dried Multidose Formulation Administered in Healthy Volunteers
The primary objective of the trial was to assess the bioequivalence for two concentrations (5.83 mg/mL and 8 mg/mL) of the new r-hGH liquid multidose formulation using the r hGH freeze-dried multidose formulation (Saizen® 8 mg, 8.8 mg/1.51 mL) as reference.
Each volunteer received three r hGH treatments, with each treatment being administered as a single subcutaneous dose of 4 mg r-hGH in a randomized sequence with at least one week of wash-out period between successive treatments.
- Conditions
- Growth Failure, Growth Hormone Deficiency
- Being tested
- r-hGH liquid (Saizen), r-hGH freeze-dried
- Keywords
- Saizen®, bioequivalence, recombinant human, Growth Hormone, treatment of growth failure in children, growth hormone deficiency in adults
- Medical subject headings
- Failure to Thrive, Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
r-hGH liquid (Saizen)Biological
Treatment Arm A: r-hGH liquid multidose formulation 5.83 mg/mL, needle injection (0.686 mL)
r-hGH liquid (Saizen)Biological
Treatment Arm B: r-hGH liquid multidose formulation 8.0 mg/mL, needle injection (0.5 mL)
r-hGH freeze-driedBiological
Treatment Arm C: r-hGH 8 mg (8.8 mg/1.51 ml) freeze-dried formulation ( reconstituted in metacresol 0.3% w/v) needle injection (0.686 mL)
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Not described Receives: Biological: r-hGH liquid (Saizen) |
| Arm B | Experimental | Not described Receives: Biological: r-hGH liquid (Saizen) |
| Arm C | Experimental | Not described Receives: Biological: r-hGH freeze-dried |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoints were the pharmacokinetic (PK) parameters of r-hGH: the area under the serum concentration-time curve from time zero to last detectable serum concentration (AUC0 t) and the maximum observed serum concentration (Cmax).
Measured: 24 hours post r hGH dose
Secondary outcomes (2)
Secondary endpoints included further PK parameters.
Measured: 15 +/-3 days post last r hGH dose
Safety and tolerability were evaluated by adverse events (AEs), medical history, physical examination, vital signs, local tolerability, visual analog scale (VAS), ECG recordings, glycemia measurements and laboratory tests.
Measured: 15 +/-3 days post last r hGH dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2009 (estimated)
- Study startJul 2008
- Primary completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Growth FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMD Serono
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Lissy, MD, Principal investigator, AAIPharma Deutschland GmbH & Co. KG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01034735
- Sponsor's protocol ID
- 28798
- Status last verified
- Oct 2013
- First submitted
- 16 Dec 2009
- Last updated
- 23 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Liedert B, Forssmann U, Wolna P, Golob M, Kovar A. Comparison of the pharmacokinetics, safety and tolerability of two concentrations of a new liquid recombinant human growth hormone formulation versus the freeze-dried formulation. BMC Clin Pharmacol. 2010 Oct 20;10:14. doi: 10.1186/1472-6904-10-14.
PubMed 20961422
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I, Open Label, Randomised Three-way Cross Over, Single-centre Trial to Assess the Bioequivalence for Two Concentrations of the New r-hGH Liquid Multidose Formulation Versus the r-hGH Freeze-dried Multidose Formulation Administered in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01034735
- Acronym / sponsor ID
- 28798
- Conditions
- Growth Failure, Growth Hormone Deficiency
- Keywords
- Saizen®, bioequivalence, recombinant human, Growth Hormone, treatment of growth failure in children, growth hormone deficiency in adults
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- EMD SeronoIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Aug 2008 (actual)
- First posted
- 17 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the trial was to assess the bioequivalence for two concentrations (5.83 mg/mL and 8 mg/mL) of the new r-hGH liquid multidose formulation using the r hGH freeze-dried multidose formulation (Saizen® 8 mg, 8.8 mg/1.51 mL) as reference.
Each volunteer received three r hGH treatments, with each treatment being administered as a single subcutaneous dose of 4 mg r-hGH in a randomized sequence with at least one week of wash-out period between successive treatments.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Biological: r-hGH liquid (Saizen) |
| Arm B | Experimental | Biological: r-hGH liquid (Saizen) |
| Arm C | Experimental | Biological: r-hGH freeze-dried |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Male and female aged 18 to 45 years, inclusive; who are able to read, to write and to fully understand German language
- Had given written Informed Consent
- Had a body weight greater than 55 kg and a body mass index (BMI) of >20 and < or = 30 kg/m2 (BMI = weight (kg)/height (m)2)
- Had vital signs in the following normal range:
- Ear body temperature: 35.0 - 38.0°C
Key exclusion criteria (11 listed)
- Any surgical or medical condition, including findings in the medical history or in the pre trial assessments, that in the opinion of the Investigator, constituted a risk or a contraindication for the participation of the subject in the trial or that could have interfered with the trial objectives, conduct or evaluation
- Had any clinically significant abnormal laboratory test results in the pre-trial safety laboratory tests or any clinically abnormal findings on the 12 leads resting electrocardiogram (ECG) that in the opinion of the Investigator may have increased the safety risk to the subject
- Had positive results for drugs of abuse or alcohol test
- Had positive results from serology examination for Hepatitis B surface antigen (HBsAg) (not due to vaccination), Hepatitis B core antibody (HBcAb) (if positive, was to be verified by test for anti-Hbc-IgM), Hepatitis C Virus (anti-HCV) and Human Immunodeficiency Virus (anti-HIV 1 and 2) at screening
- History or presence of hypertension or other significant cardiovascular abnormalities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| r-hGH liquid (Saizen)Treatment Arm A: r-hGH liquid multidose formulation 5.83 mg/mL, needle injection (0.686 mL) | Biological | Arm A |
| r-hGH liquid (Saizen)Treatment Arm B: r-hGH liquid multidose formulation 8.0 mg/mL, needle injection (0.5 mL) | Biological | Arm B |
| r-hGH freeze-driedTreatment Arm C: r-hGH 8 mg (8.8 mg/1.51 ml) freeze-dried formulation ( reconstituted in metacresol 0.3% w/v) needle injection (0.686 mL) | Biological | Arm C |
Primary outcome
Primary endpoints were the pharmacokinetic (PK) parameters of r-hGH: the area under the serum concentration-time curve from time zero to last detectable serum concentration (AUC0 t) and the maximum observed serum concentration (Cmax).
Time frame: 24 hours post r hGH dose
2 secondary outcomes
Secondary endpoints included further PK parameters.
Time frame: 15 +/-3 days post last r hGH dose
Safety and tolerability were evaluated by adverse events (AEs), medical history, physical examination, vital signs, local tolerability, visual analog scale (VAS), ECG recordings, glycemia measurements and laboratory tests.
Time frame: 15 +/-3 days post last r hGH dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2013.
- Derived from this study: PubMed 20961422Liedert B, Forssmann U, Wolna P, Golob M, Kovar A. Comparison of the pharmacokinetics, safety and tolerability of two concentrations of a new liquid recombinant human growth hormone formulation versus the freeze-dried formulation. BMC Clin Pharmacol. 2010 Oct 20;10:14. doi: 10.1186/1472-6904-10-14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Lissy, MD principal investigator
AAIPharma Deutschland GmbH & Co. KG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing r-hGH liquid (Saizen) and r-hGH freeze-dried in people with Growth Failure and Growth Hormone Deficiency, run by EMD Serono at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary endpoints were the pharmacokinetic (PK) parameters of r-hGH: the area under the serum concentration-time curve from time zero to last detectable serum concentration (AUC0 t) and the maximum observed serum concentration (Cmax). (time frame: 24 hours post r hGH dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01034735, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2013.