Adult Growth Hormone DeficiencyPhase 2HM10560ANCT01822340
Safety and Efficacy Study of Recombinant Human Growth Hormone in Adult Growth Hormone Deficiency Patients
A Phase 2 study testing HM10560A and Genotropin in people with Adult Growth Hormone Deficiency, run by Hanmi Pharmaceutical Company Limited at 1 site in Hungary.
Trial summary
The purpose of this study is to assess the safety, tolerability and Pharmacokinetic/ Pharmacodynamic (PK/PD) profile of three doses of HM10560A on an every week (EW) regime and one dose on every other week (EOW) regime administered for a period of 24 weeks initial study. Read more about this study
- Who is it for?
- Ages 23 to 60 years
- Conditions the study is for
- Adult Growth Hormone Deficiency
- What is being tested?
- HM10560A and Genotropin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteHungary
- Study dates
- Oct 2011to Feb 2016
- Phase
- Phase 2
- 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 23 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- GHDA subjects, males and females, of age between 23 and 60 years as defined in the Consensus Guidelines for the Diagnosis and Treatment of Adults with GH Deficiency II (2007) as well as American Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice for Growth Hormone Use in Growth Hormone-Deficient Adults and Transition Patients (2009);
- r-hGHdrug naïve or any registered or investigational r-hGH replacement therapy was not given for more than 6 months before the screening.
- Body Mass Index (BMI, kg/m2) of both male and female patients must be between 22.0 to 35.0 kg/m2.
- Female patients must have a negative serum pregnancy test at inclusion.
- Confirmed to be negative for anti r-hGH antibodies at the time of screening.
- Willing and able to provide written informed consent prior to performing any study procedures.
Who cannot join
- Patients with childhood onset of GHD treated with r-hGH before the age of 18.
- Current antitumor therapy.
- Subjects presenting with any clinically significant ECG abnormality.
- Evidence of intracranial hypertension.
- Significant hepatic dysfunction (persistent elevation of alanine transaminase [ALT] or aspartate transaminase [AST] >1.5 x upper limit of normal).
- Pregnancy and breastfeeding;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II, Randomized, Active Controlled, Open Label Study of Safety and Efficacy of HM10560A a Long-acting rhGH-HMC001 Conjugate in Treatment of Subjects Suffering From Adult Growth Hormone Deficiency (AGHD)
The purpose of this study is to assess the safety, tolerability and Pharmacokinetic/ Pharmacodynamic (PK/PD) profile of three doses of HM10560A on an every week (EW) regime and one dose on every other week (EOW) regime administered for a period of 24 weeks initial study.
Read the detailed description
- To select the optimal dose and dosing regimen of HM10560A for the subsequent phase III study on the basis of the safety and PK/PD profile after 24 weeks of treatment
- To assess the long term safety of HM10560A when administered in optimal dose range and dose frequency for additional 48 weeks (followed with 2 weeks safety follow up)
- Conditions
- Adult Growth Hormone Deficiency
- Being tested
- HM10560A, Genotropin
- Keywords
- AGHD
- Medical subject headings
- Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HM10560ADrug
Also called LAPS-rhGH
Once weekly HM10560A
GenotropinDrug
Also called Genotropin 5.3mg
Once daily Genotropin
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Once weekly HM10560A Receives: Drug: HM10560A |
| Cohort 2 | Experimental | Once weekly HM10560A Receives: Drug: HM10560A |
| Cohort 3 | Experimental | Once weekly HM10560A Receives: Drug: HM10560A |
| Cohort 4 | Experimental | Biweekly HM10560A Receives: Drug: HM10560A |
| Cohort 5 | Active comparator | Once daily Genotropin Receives: Drug: Genotropin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of IGF-I levels in function of time, and dose strengths
The results from each month minus baseline
Measured: baseline, 1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18 months
Secondary outcomes (1)
IGF-I SDS; changes to baseline in IGF-I SDS
The results from each month minus baseline
Measured: baseline, 1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2013 (estimated)
- Study startOct 2011
- Primary completionJun 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Growth Hormone DeficiencyStudies of the same condition, open and under way.
- More trials run by Hanmi Pharmaceutical Company LimitedThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01822340
- Sponsor's protocol ID
- 11-HM10560A-201
- Acronym
- HM10560A
- Status last verified
- Feb 2016
- First submitted
- 25 Mar 2013
- Last updated
- 19 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Active Controlled, Open Label Study of Safety and Efficacy of HM10560A a Long-acting rhGH-HMC001 Conjugate in Treatment of Subjects Suffering From Adult Growth Hormone Deficiency (AGHD)
- ClinicalTrials.gov ID
- NCT01822340
- Acronym / sponsor ID
- HM10560A / 11-HM10560A-201
- Conditions
- Adult Growth Hormone Deficiency
- Keywords
- AGHD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Jun 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 2 Apr 2013 (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 purpose of this study is to assess the safety, tolerability and Pharmacokinetic/ Pharmacodynamic (PK/PD) profile of three doses of HM10560A on an every week (EW) regime and one dose on every other week (EOW) regime administered for a period of 24 weeks initial study.
Detailed description
- To select the optimal dose and dosing regimen of HM10560A for the subsequent phase III study on the basis of the safety and PK/PD profile after 24 weeks of treatment
- To assess the long term safety of HM10560A when administered in optimal dose range and dose frequency for additional 48 weeks (followed with 2 weeks safety follow up)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: HM10560AOnce weekly HM10560A |
| Cohort 2 | Experimental | Drug: HM10560AOnce weekly HM10560A |
| Cohort 3 | Experimental | Drug: HM10560AOnce weekly HM10560A |
| Cohort 4 | Experimental | Drug: HM10560ABiweekly HM10560A |
| Cohort 5 | Active comparator | Drug: GenotropinOnce daily Genotropin |
Who may qualify
- Ages
- 23 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- GHDA subjects, males and females, of age between 23 and 60 years as defined in the Consensus Guidelines for the Diagnosis and Treatment of Adults with GH Deficiency II (2007) as well as American Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice for Growth Hormone Use in Growth Hormone-Deficient Adults and Transition Patients (2009);
- r-hGHdrug naïve or any registered or investigational r-hGH replacement therapy was not given for more than 6 months before the screening.
- Body Mass Index (BMI, kg/m2) of both male and female patients must be between 22.0 to 35.0 kg/m2.
- Female patients must have a negative serum pregnancy test at inclusion.
- Confirmed to be negative for anti r-hGH antibodies at the time of screening.
Key exclusion criteria (6 listed)
- Patients with childhood onset of GHD treated with r-hGH before the age of 18.
- Current antitumor therapy.
- Subjects presenting with any clinically significant ECG abnormality.
- Evidence of intracranial hypertension.
- Significant hepatic dysfunction (persistent elevation of alanine transaminase [ALT] or aspartate transaminase [AST] >1.5 x upper limit of normal).
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 |
|---|---|---|
| HM10560AAlso: LAPS-rhGHOnce weekly HM10560A | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
| GenotropinAlso: Genotropin 5.3mgOnce daily Genotropin | Drug | Cohort 5 |
Primary outcome
Change of IGF-I levels in function of time, and dose strengths
Time frame: baseline, 1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18 months
The results from each month minus baseline
1 secondary outcome
IGF-I SDS; changes to baseline in IGF-I SDS
Time frame: baseline, 1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18 months
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 19 Feb 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HM10560A and Genotropin in people with Adult Growth Hormone Deficiency, run by Hanmi Pharmaceutical Company Limited at 1 site in Hungary.
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 6 inclusion and 6 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 19 Feb 2016. 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 Hungary. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change of IGF-I levels in function of time, and dose strengths (time frame: baseline, 1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Feb 2016.