A Research Study in Children Born Small and Who Stayed Small. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03878446 |
|
Recruitment Status :
Active, not recruiting
First Posted : March 18, 2019
Last Update Posted : March 28, 2023
|
Sponsor:
Novo Nordisk A/S
Information provided by (Responsible Party):
Novo Nordisk A/S
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Brief Summary:
The study compares 2 medicines used for the treatment of children who are born small and who stayed small: somapacitan given once a week (a new medicine) and Norditropin® given once a day (the medicine doctors can already prescribe).
Participants will either get somapacitan or Norditropin® - which treatment is decided by chance. Both participants and the study doctor will know which treatment the participants get. The study will last for 4 years. Participants will take either an injection once every week or once every day. Participants will have 9 clinic visits and will be in the study for 1 year. The follow-up period is at least 30 days.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Short Stature Children Born Small for Gestational Age (SGA) | Drug: somapacitan Drug: Norditropin® | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 62 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Dose-finding Trial Evaluating the Effect and Safety of Once-weekly Treatment of Somapacitan Compared to Daily Norditropin® in Children With Short Stature Born Small for Gestational Age With no Catch-up Growth by 2 Years of Age or Older |
| Actual Study Start Date : | July 4, 2019 |
| Actual Primary Completion Date : | May 5, 2021 |
| Estimated Study Completion Date : | May 12, 2025 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: 0.24 mg/kg somapacitan
Same treatment in main period (13 weeks) and extension period (39 weeks)
|
Drug: somapacitan
Somapacitan injected under the skin once a week for a total of 52 weeks |
|
Experimental: 0.20 mg/kg somapacitan
Same treatment in main period (13 weeks) and extension period (39 weeks)
|
Drug: somapacitan
Somapacitan injected under the skin once a week for a total of 52 weeks |
|
Experimental: 0.16 mg/kg somapacitan
Same treatment in main period (13 weeks) and extension period (39 weeks)
|
Drug: somapacitan
Somapacitan injected under the skin once a week for a total of 52 weeks |
|
Active Comparator: 0.035 mg/kg Norditropin®
Same treatment in main period (13 weeks) and extension period (39 weeks)
|
Drug: Norditropin®
Norditropin® injected under the skin once a day for a total of 52 weeks |
|
Active Comparator: 0.067 mg/kg Norditropin®
Same treatment in main period (13 weeks) and extension period (39 weeks)
|
Drug: Norditropin®
Norditropin® injected under the skin once a day for a total of 52 weeks |
Primary Outcome Measures :
- Height velocity [ Time Frame: From baseline (week 0) to week 26 ]cm/year
Secondary Outcome Measures :
- Change in bone age [ Time Frame: From baseline (week 0) to week 52 ]years
- Change in height standard deviation score (SDS) [ Time Frame: From baseline (week 0) to week 26 ]-10 to +10
- Change in height velocity SDS [ Time Frame: From baseline (week 0) to week 26 ]-10 to +10
- Change in fasting plasma glucose [ Time Frame: From screening (visit 1) to week 26 ]mmol/l
- Change in homeostatic model assessment (HOMA) [ Time Frame: From screening (visit 1) to week 26 ]Percent
- Change in glycated haemoglobin (HbA1c) [ Time Frame: From screening (visit 1) to week 26 ]Percentage points
- Change in insulin-like growth factor I (IGF-I) SDS [ Time Frame: From screening (visit 1) to week 26 ]-10 to +10
- Change in insulin-like growth factor binding protein 3 (IGFBP-3) SDS [ Time Frame: From screening (visit 1) to week 26 ]-10 to +10
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 2 Years to 11 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
-
Pre-pubertal children, boys:
- age between 2.5 and 11.0 years at screening.
- testes volume below 4 ml.
-
Pre-pubertal children, girls:
- age between 2.5 and 10.0 years at screening.
- Tanner stage 1 for breast development (no palpable glandular breast tissue).
- Born small for gestational age (birth length and/or weight below -2 standard deviation scores) (according to national standards).
- Impaired height defined as at least 2.5 standard deviations below the mean height for chronological age and gender at screening according to the standards of Centers for Disease Control and Prevention at screening.
- Impaired height velocity defined as annualized height velocity below the 50th percentile for chronological age and gender according to the standards of Prader calculated over a time span of minimum 6 months and maximum 18 months prior to screening.
- No prior exposure to growth hormone therapy or Insulin-like Growth Factor-I (IGF-I) treatment.
Exclusion Criteria:
- Any known or suspected clinically significant abnormality likely to affect growth or the ability to evaluate growth with standing height measurements.
- Children with hormonal deficiencies including suspected or confirmed growth hormone deficiency according to local practise.
- Current inflammatory diseases requiring systemic corticosteroid treatment for longer than 2 consecutive weeks within the last 3 months prior to screening.
- Children requiring inhaled glucocorticoid therapy at a dose of greater than 400 μg/day of inhaled budesonide or equivalents for longer than 4 consecutive weeks within the last 12 months prior to screening.
- Concomitant administration of other treatments that may have an effect on growth, e.g but not limited to methylphenidate for treatment of attention deficit hyperactivity disorder.
- Diagnosis of attention deficit hyperactivity disorder.
- Prior history or presence of malignancy including intracranial tumours.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03878446
Locations
Show 67 study locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
| Study Director: | Clinical Reporting Anchor and Disclosure 1452 | Novo Nordisk A/S |
| Responsible Party: | Novo Nordisk A/S |
| ClinicalTrials.gov Identifier: | NCT03878446 |
| Other Study ID Numbers: |
NN8640-4245 U1111-1207-9741 ( Other Identifier: World Health Organization (WHO) ) 2018-000232-10 ( EudraCT Number ) |
| First Posted: | March 18, 2019 Key Record Dates |
| Last Update Posted: | March 28, 2023 |
| Last Verified: | March 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | According to the Novo Nordisk disclosure commitment on novonordisk-trials.com |
| URL: | http://novonordisk-trials.com |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
|
Dwarfism Bone Diseases, Developmental Bone Diseases |
Musculoskeletal Diseases Genetic Diseases, Inborn Endocrine System Diseases |