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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1207-9741 | Other Identifier | World Health Organization (WHO) | |
| 2018-000232-10 | EudraCT Number |
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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 5 years. Participants will take either an injection once every week or once every day.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Somapacitan 0.24 mg/kg/week | Experimental | Same treatment in main period (26 weeks) and extension period I (26 weeks). Dosage of Somapacitan during extension period II will be determined based on the data from main phase. |
|
| Somapacitan 0.20 mg/kg/week | Experimental | Same treatment in main period (26 weeks) and extension period I (26 weeks). Dosage of Somapacitan during extension period II will be determined based on the data from main phase. |
|
| Somapacitan 0.16 mg/kg/week | Experimental | Same treatment in main period (26 weeks) and extension period I (26 weeks). Dosage of Somapacitan during extension period II will be determined based on the data from main phase. |
|
| Norditropin® 0.035 mg/kg/day | Active Comparator | Same treatment in main period (26 weeks) and extension period I (26 weeks). Participants will switch to Somapacitan during extension period II. Dosage of Somapacitan during extension period II will be determined based on the data from main phase. |
|
| Norditropin® 0.067 mg/kg/day | Active Comparator | Same treatment in main period (26 weeks) and extension period I (26 weeks). Participants will switch to Somapacitan during extension period II. Dosage of Somapacitan during extension period II will be determined based on the data from main phase. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Somapacitan | Drug | Somapacitan injected under the skin once a week. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Height Velocity | Height velocity (HV) was derived from height measurements taken at baseline (week 0) and week 26 visit as: HV = (height at 26 weeks visit - height at baseline)/(time from baseline to 26 weeks visit in years). The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: from first administration and up until week 26 or last trial contact, whichever came first. | Baseline (week 0); week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Ratio of Bone Age Versus Chronological Age | Change in ratio of bone age (years) versus chronological age (years) from baseline (week 0) to week 52 is presented. X-rays of left hand and wrist for bone age assessment according to the Greulich and Pyle atlas were taken. X-ray images were sent to a central imaging laboratory for evaluation. Chronological Age (years) was calculated as: (Date minus Date of Birth) divided by 365.25. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: from first administration and up until week 52 or last trial contact, whichever came first. |
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Inclusion Criteria:
Pre-pubertal children, boys:
Pre-pubertal children, girls:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Reporting Anchor and Disclosure 1452 | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univ of AL at Birmingham_BRM | Birmingham | Alabama | 35233 | United States | ||
| Children's Hosp Of Orange |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41614610 | Derived | Juul A, Hojby M, Kawai M, Linglart A, Mori J, Zuckerman-Levin N, Backeljauw P. Somapacitan in children born small for gestational age: 4-year results from phase 2. Eur J Endocrinol. 2026 Feb 4;194(2):157-169. doi: 10.1093/ejendo/lvag017. |
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According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Participants were randomized (1:1:1:1:1 ratio) to receive either once-weekly Somapacitan or daily Norditropin treatment during the main phase (26-week) and extension phase I (26-week). Followed by 208-week additional long-term safety extension phase (extension II) and a 30-day follow-up period. Results in this summary are reported based on main phase and extension phase I. The extension phase II is still ongoing and results will be posted after one year of study completion date.
The trial was conducted at 38 sites in 12 countries as follows (number of sites that screened participants/ number of sites that randomized participants): Austria (2/1), France (2/2), Hungary (1/1), India (3/3), Israel (1/1), Italy (2/2), Japan (10/10), Latvia (1/1), Russia (6/6), Thailand (2/1), Ukraine (2/2) and United States (6/5).
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| ID | Title | Description |
|---|---|---|
| FG000 | Norditropin 0.035 mg/kg/Day | Participants received 0.035 mg/kg/day subcutaneous injection of norditropin daily during the main phase (26-week) and extension phase I (26-week). |
| FG001 | Norditropin 0.067 mg/kg/Day |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 12, 2020 |
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| Norditropin® | Drug | Norditropin® injected under the skin once a day. |
|
| Baseline (week 0); week 52 |
| Change in Height Standard Deviation Score (HSDS) | Change in HSDS from baseline (week 0) to week 26 is presented. HSDS was derived using Centre for Disease Control and Prevention (CDC) standards. HSDS = [(height/population median)^skewness - 1]/(skewness * population standard deviation) where skewness, median and standard deviation is given by a reference growth table for the corresponding chronological age. The range for HSDS was -10 to +10. Negative scores indicated a height below the mean height for a child with the same age and gender, whereas positive scores indicated a height above the mean height for a child with the same age and gender. Positive value in change from baseline in HSDS indicated that HSDS was better than baseline HSDS In-trial observation period: from first administration and up until week 26 or last trial contact, whichever came first. | Baseline (week 0); week 26 |
| Change in Height Velocity Standard Deviation Score (HVSDS) | Change in HVSDS from baseline (week 0) to week 26 is presented. HVSDS was derived using Prader standards. HV SDS was calculated using the formula: HV SDS = (height velocity - mean)/standard deviation (SD), where height velocity was the height velocity variable measured, mean and SD of height velocity by gender and age for the reference population. The range for HVSDS was -10 to +10. Negative scores indicated a height velocity below the mean height velocity for a child with the same age and gender, whereas positive scores indicated a height velocity above the mean height velocity for a child with the same age and gender. Positive value in change from baseline in HVSDS indicated that HVSDS was better than baseline HVSDS. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: from first administration and up until week 26 or last trial contact, whichever came first. | Baseline (week 0); week 26 |
| Change in Fasting Plasma Glucose | Change in fasting plasma glucose from baseline (week 0) to week 26 is presented. The outcome measure was evaluated based on the data from on-treatment observation period. On-treatment observation period: from first administration and up until last trial contact, week 26 or 14 days after last administration, whichever came first. | Baseline (week 0); week 26 |
| Change in Homeostatic Model Assessment for Steady State Beta Cell Function (HOMA-B) | Change in HOMA-B from baseline (week 0) to week 26 is presented. HOMA-B is a measure of the beta cell function and was calculated as follows: HOMA-B = (20 * fasting insulin (picomoles per liter [pmol/L]) * 1/6(microunit per milliliter [µU/mL]))/ FPG(mmol/L)-3.5). HOMA-beta score ranges from minus infinity to infinity (no limits). Higher score means better beta-cell function for HOMA-beta. Negative change from baseline (week 0) in HOMA-B indicated a worse outcome. The outcome measure was evaluated based on the data from on-treatment observation period. On-treatment observation period: from first administration and up until last trial contact, week 26 or 14 days after last administration, whichever came first. | Baseline (week 0); week 26 |
| Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) | Change in HOMA-IR from baseline (week 0) to week 26 is presented. Insulin resistance is a condition in which cells fail to respond to normal actions of hormone in body. HOMA-IR is calculated using a participant's fasting plasma insulin and glucose levels. HOMA-IR = fasting serum insulin (micro international units per milliliter (μU/ml)) × fasting plasma glucose (millimoles per liter (mmol/l)) / 22.5. HOMA-IR scores are classified as follows: less than 1.0: considered insulin sensitive, 0.5-1.4: considered healthy, above 1.8: considered early insulin resistance; above 2.7 is considered significant insulin resistance. HOMA-IR score ranges from 0-infinity (no upper limit). Higher the score, higher the level of insulin resistance. The outcome measure was evaluated based on the data from on-treatment observation period. On-treatment observation period: from first administration and up until last trial contact, week 26 or 14 days after last administration, whichever came first. | Baseline (week 0); week 26 |
| Change in Glycated Haemoglobin (HbA1c) | Change in HbA1c from baseline (week 0) to week 26 is presented. The outcome measure was evaluated based on the data from on-treatment observation period. On-treatment observation period: from first administration and up until last trial contact, week 26 or 14 days after last administration, whichever came first. | Baseline (week 0); week 26 |
| Change in Insulin-like Growth Factor I (IGF-I) Standard Deviation Score (SDS) | Change in IGF-I SDS from baseline (week 0) to week 26 is presented. IGF-I 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. The range for IGF-I SDS was from -10 to +10. Negative scores indicated a IGF-I below the mean IGF-I for a child with the same age and gender, whereas positive scores indicated a IGF-I above the mean IGF-I for a child with the same age and gender. Positive value in change from baseline in IGF-I SDS indicated that IGF-I SDS was higher than baseline IGF-I SDS. The outcome measure was evaluated based on the data from on-treatment observation period. On-treatment observation period: from first administration and up until last trial contact, week 26 or 14 days after last administration, whichever came first. | Baseline (week 0); week 26 |
| Change in Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) SDS | Change in IGFBP-3 SDS from baseline (week 0) to week 26 is presented. The range for IGFBP-3 SDS was from -10 to +10. Negative scores indicated a IGFBP-3 below the mean IGFBP-3 for a child with the same age and gender, whereas positive scores indicated a IGFBP-3 above the mean IGFBP-3 for a child with the same age and gender. Positive value in change from baseline in IGFBP-3 SDS indicated that IGFBP-3 SDS was higher than baseline IGFBP-3 SDS. The outcome measure was evaluated based on the data from on-treatment observation period. On-treatment observation period: from first administration and up until last trial contact, week 26 or 14 days after last administration, whichever came first. | Baseline (week 0); week 26 |
| Orange |
| California |
| 92868 |
| United States |
| St. Luke's Children's Endo | Boise | Idaho | 83712 | United States |
| Univ of Minnesota M.C.H. | Minneapolis | Minnesota | 55454 | United States |
| Children's Minnesota | Saint Paul | Minnesota | 55102 | United States |
| Goryeb Children's Hospital | Morristown | New Jersey | 07962 | United States |
| Rutgers-Rwjms | New Brunswick | New Jersey | 08901 | United States |
| NYU Langone Hospital-LI | Garden City | New York | 11530 | United States |
| NYU Langone Hospital-LI | Mineola | New York | 11501 | United States |
| Icahn Sch of Med-Mt Sinai Hosp | New York | New York | 10029 | United States |
| CCHMC_Cinc | Cincinnati | Ohio | 45229 | United States |
| Univ Oklahoma Sci Ctr OK City | Oklahoma City | Oklahoma | 73104 | United States |
| Cook Children's Hospital-Hematology-Oncology | Fort Worth | Texas | 76104 | United States |
| MultiCare Inst for Res & Innov | Tacoma | Washington | 98405 | United States |
| CHU Bab El Oued Pediatrics Dept | Algiers | 16000 | Algeria |
| Endo and Diab Dept El Oued | Algiers | 16000 | Algeria |
| endocrino-diabetology department, Hospital IBN BADIS. | Constantine | 25000 | Algeria |
| Kepler Universitätsklinikum GmbH - Med Campus IV (vorm.LFKK) | Linz | Upper Austria | 4020 | Austria |
| Med. Univ. Graz -Klinische Abteilung f. Allgemeine Pädiatrie | Graz | 8036 | Austria |
| LKH Salzburg- Univ. Klinik f. Kinder- und Jugendheilkunde | Salzburg | A 5020 | Austria |
| LKH St. Poelten, Kinder-und Jugendheilkunde | Sankt Pölten | 3100 | Austria |
| Salzkammergut-Klinikum Vöcklabruck | Vöcklabruck | 4840 | Austria |
| Stollery Children's Hospital | Edmonton | Alberta | T6G 2B7 | Canada |
| Rigshospitalet Klinik for Vækst og Reproduktion Afsnit 5064 | Copenhagen Ø | 2100 | Denmark |
| Tallinn Children's Hospital | Tallinn | 13419 | Estonia |
| Tartu University Hospital Children's Clinic | Tartu | 50406 | Estonia |
| Centre Hospitalier Universitaire D'Angers-2 | Angers | 49100 | France |
| AP-HP-HOPITAL DE BICETRE_Service d'Endocrinologie pédiatrique | Le Kremlin-Bicêtre | 94270 | France |
| Assistance Publique Hopitaux de Marseille-Hopital de La Timone-2 | Marseille | 13005 | France |
| Hopital de La Timone | Marseille Cédex 05 | 13385 | France |
| Ap-Hp-Hopital Necker | Paris | 75015 | France |
| Hôpital Necker | Paris | 75015 | France |
| HOPITAL DES ENFANTS-HOPITAL PAULE DE VIGUIER - Pharmacie | Toulouse | 31059 | France |
| Észak-Közép-budai Centrum, Szent János Kórház és Szakrendelő | Budapest | 1023 | Hungary |
| Szegedi Tudományegyetem Gyermekgyógyászati Klinika | Szeged | 6720 | Hungary |
| Amrita Institute Of Medical Sciences & Research Centre | Kochi | Kerala | 682041 | India |
| Jehangir Clinical Development Centre | Pune | Maharashtra | 411001 | India |
| All India Institute of Medical Sciences | New Dehli | New Delhi | 110029 | India |
| CHI Crumlin Dept of Endocrinology | Dublin | D12 N512 | Ireland |
| Rambam MC - Department of Pediatrics A | Haifa | 31096 | Israel |
| Meir MC - Department of Paediatrics | Kfar Saba | 44281 | Israel |
| Schneider MC - Endrocrinology and Diabetes | Petah Tikva | 49202 | Israel |
| IRCCS Meyer Firenze | Florence | 50139 | Italy |
| Ospedale Pediatrico Gaslini | Genova | 16147 | Italy |
| Ospedale Maggiore Policlinico UO Endocrinologia Diabetolgia | Milan | 20122 | Italy |
| Ospedale Pediatrico Bambino Gesu | Roma | 00165 | Italy |
| Kurume University Hospital, Pediatrics | Fukuoka | 830-0011 | Japan |
| Fukuoka Children's Hospital_Endocrinology and Metabolism | Fukuoka-shi, Fukuoka | 813-0017 | Japan |
| Fukuoka Children's Hospital | Fukuoka-shi, Fukuoka | 813-0017 | Japan |
| Fukuyama City Hospital_Department of Pediatrics | Fukuyama-shi, Hiroshima | 721-8511 | Japan |
| Hyogo Prefectual Kobe Children's Hospital Dept. Metab & endo | Kobe-shi, Hyogo | 650-0047 | Japan |
| Hyogo Prefectual Kobe Children's Hospital_Metab & endo | Kobe-shi, Hyogo | 650-0047 | Japan |
| Univ.HP, Kyoto Pref Univ of Medicine, Dept. of Pediatrics | Kyoto | 602-8566 | Japan |
| Nara Prefecture General Medical Center_ Nara-shi, Nara | Nara-shi, Nara | 630-8581 | Japan |
| Nara Prefecture General Medical Center_Pediatric | Nara-shi, Nara | 630-8581 | Japan |
| Niigata University Medical & Dental Hospital_Pediatrics | Niigata-shi, Niigata | 951 8520 | Japan |
| Osaka City General Hospital, Pediatric Endocrinology and Me | Osaka | 534-0021 | Japan |
| Osaka Women's and Children's Hospital | Osaka | 594-1101 | Japan |
| Saitama Children's Medical Center, Endocrinorogy&Metabolism | Saitama-shi, Saitama | 330-8777 | Japan |
| Institute of Science Tokyo Hospital_Pediatrics | Tokyo | 113-8519 | Japan |
| Institute of Science Tokyo Hospital | Tokyo | 113-8519 | Japan |
| National Center for Child Health and Dev, Endo and Metabo | Tokyo | 157 8535 | Japan |
| National Center for Child Health and Development_Endo and Metabo | Tokyo | 157 8535 | Japan |
| Keio University Hospital_Pediatrics | Tokyo | 160-8582 | Japan |
| Children's Clinical University Hospital | Riga | 1004 | Latvia |
| Haukeland Universitetssykehus, Barneklinikken | Bergen | 5021 | Norway |
| SPSK nr 1 im Prof. T Sokolowskiego | Szczecin | 71-252 | Poland |
| Instytut ''Pomnik - Centrum Zdrowia Dziecka'' | Warsaw | 04-730 | Poland |
| Republic Children's Hospital of Ministry of Health of Udmurt | Izhevsk | 426009 | Russia |
| Setchenov First Moscow State Medical University | Moscow | 119435 | Russia |
| RMAPE | Moscow | 125373 | Russia |
| Children's clinical city hospital #1 | Novosibirsk | 630048 | Russia |
| FSBEI of Higher Education "Rostov State Medical University" | Rostov-on-Don | 344013 | Russia |
| SPSBHI City Children out-patient clinic #44 | Saint Petersburg | 191144 | Russia |
| Samara Regional Children Clinical Hospital n.a. N.N. Ivanova | Samara | 443079 | Russia |
| Siberian State Medical University | Tomsk | 634050 | Russia |
| University Children's Hospital Tirsova | Belgrade | 11000 | Serbia |
| Institute for Mother and Child Health Care of Serbia | Belgrade | 11070 | Serbia |
| University Clinical Centre Kragujevac | Kragujevac | 34000 | Serbia |
| Clinical Center in Nis | Niš | 18 000 | Serbia |
| Institute for Health Care of Children and Adolescents | Novi Sad | 21000 | Serbia |
| Hospital Sant Joan de Déu | Esplugues Llobregat(Barcelona) | 08950 | Spain |
| Hospital ClÃnico de Santiago de Compostela | Santiago de Compostela | 15706 | Spain |
| Med. Kinder- und Poliklinik | Bern | 3010 | Switzerland |
| Kinderspital Endokrinologie, Zürich | Zurich | 8032 | Switzerland |
| King Chulalongkorn Memorial hospital-Ped-Endocrinology | Bangkok | 10330 | Thailand |
| King Chulalongkorn Memorial hospital_Ped-Endocrinology | Bangkok | 10330 | Thailand |
| Phramongkutklao Hospital_Ped-Endo_Pediatrics | Bangkok | 10400 | Thailand |
| Dnipropetrovsk Regional Children's Clinical Hospital - Endocrinology department | Dnipro | 49100 | Ukraine |
| Kharkiv Regional Children's Clinical Hospital - Endocrinological department | Kharkiv | 61093 | Ukraine |
| Komisarenko Institute of Endocrinology and Metabolism of NAMSU - Department of paediatric endocrine pathology | Kyiv | 04114 | Ukraine |
| Hull Royal Infirmary | Hull | HU3 2JZ | United Kingdom |
| Alder Hey Children's Hospital | Liverpool | L12 2AP | United Kingdom |
| Royal London Hospital_London | London | E1 1BB | United Kingdom |
| Royal Manchester Children's Hospital | Manchester | M13 9WL | United Kingdom |
Participants received 0.067 mg/kg/day subcutaneous injection of norditropin daily during the main phase (26-week) and extension phase I (26-week).
| FG002 | Somapacitan 0.16 mg/kg/Week | Participants received 0.16 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week). |
| FG003 | Somapacitan 0.20 mg/kg/Week | Participants received 0.20 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week). |
| FG004 | Somapacitan 0.24 mg/kg/Week | Participants received 0.24 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week). |
| Safety Analysis Set (SAS) | SAS included all randomized participants exposed to trial product. |
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| Full Analysis Set (FAS) | FAS included all randomized participants exposed to the trial product. |
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| Per Protocol Analysis Set | Participants from FAS who had not violated any inclusion/exclusion criteria and had used the randomized treatment for at least 22 weeks (for participants receiving Somapacitan) or 154 days (for participants receiving Norditropin). |
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| COMPLETED |
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| NOT COMPLETED |
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Full analysis set (FAS) included all randomized participants exposed to the trial product.
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| ID | Title | Description |
|---|---|---|
| BG000 | Norditropin 0.035 mg/kg/Day | Participants received 0.035 mg/kg/day subcutaneous injection of norditropin daily during the main phase (26-week) and extension phase I (26-week). |
| BG001 | Norditropin 0.067 mg/kg/Day | Participants received 0.067 mg/kg/day subcutaneous injection of norditropin daily during the main phase (26-week) and extension phase I (26-week). |
| BG002 | Somapacitan 0.16 mg/kg/Week | Participants received 0.16 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week). |
| BG003 | Somapacitan 0.20 mg/kg/Week | Participants received 0.20 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week). |
| BG004 | Somapacitan 0.24 mg/kg/Week | Participants received 0.24 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week). |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Height Velocity | Height velocity (HV) was derived from height measurements taken at baseline (week 0) and week 26 visit as: HV = (height at 26 weeks visit - height at baseline)/(time from baseline to 26 weeks visit in years). The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: from first administration and up until week 26 or last trial contact, whichever came first. | Full analysis set (FAS) included all randomized participants exposed to the trial product. | Posted | Mean | Standard Deviation | centimeter per year (cm/year) | Baseline (week 0); week 26 |
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| Secondary | Change in Ratio of Bone Age Versus Chronological Age | Change in ratio of bone age (years) versus chronological age (years) from baseline (week 0) to week 52 is presented. X-rays of left hand and wrist for bone age assessment according to the Greulich and Pyle atlas were taken. X-ray images were sent to a central imaging laboratory for evaluation. Chronological Age (years) was calculated as: (Date minus Date of Birth) divided by 365.25. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: from first administration and up until week 52 or last trial contact, whichever came first. | Safety anslyis set (SAS) included all randomized participants exposed to the trial product. Overall number of participants analyzed = participants with available data for this outcome measure. | Posted | Mean | Standard Deviation | ratio (bone age/chronological age) | Baseline (week 0); week 52 |
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| Secondary | Change in Height Standard Deviation Score (HSDS) | Change in HSDS from baseline (week 0) to week 26 is presented. HSDS was derived using Centre for Disease Control and Prevention (CDC) standards. HSDS = [(height/population median)^skewness - 1]/(skewness * population standard deviation) where skewness, median and standard deviation is given by a reference growth table for the corresponding chronological age. The range for HSDS was -10 to +10. Negative scores indicated a height below the mean height for a child with the same age and gender, whereas positive scores indicated a height above the mean height for a child with the same age and gender. Positive value in change from baseline in HSDS indicated that HSDS was better than baseline HSDS In-trial observation period: from first administration and up until week 26 or last trial contact, whichever came first. | FAS included all randomized participants exposed to the trial product. | Posted | Mean | Standard Deviation | score on a scale | Baseline (week 0); week 26 |
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| Secondary | Change in Height Velocity Standard Deviation Score (HVSDS) | Change in HVSDS from baseline (week 0) to week 26 is presented. HVSDS was derived using Prader standards. HV SDS was calculated using the formula: HV SDS = (height velocity - mean)/standard deviation (SD), where height velocity was the height velocity variable measured, mean and SD of height velocity by gender and age for the reference population. The range for HVSDS was -10 to +10. Negative scores indicated a height velocity below the mean height velocity for a child with the same age and gender, whereas positive scores indicated a height velocity above the mean height velocity for a child with the same age and gender. Positive value in change from baseline in HVSDS indicated that HVSDS was better than baseline HVSDS. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: from first administration and up until week 26 or last trial contact, whichever came first. | FAS included all randomized participants exposed to the trial product. | Posted | Mean | Standard Deviation | score on a scale | Baseline (week 0); week 26 |
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| Secondary | Change in Fasting Plasma Glucose | Change in fasting plasma glucose from baseline (week 0) to week 26 is presented. The outcome measure was evaluated based on the data from on-treatment observation period. On-treatment observation period: from first administration and up until last trial contact, week 26 or 14 days after last administration, whichever came first. | Safety analysis set (SAS) included all randomized participants exposed to trial product. | Posted | Mean | Standard Deviation | millimoles per liter (mmol/L) | Baseline (week 0); week 26 |
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| Secondary | Change in Homeostatic Model Assessment for Steady State Beta Cell Function (HOMA-B) | Change in HOMA-B from baseline (week 0) to week 26 is presented. HOMA-B is a measure of the beta cell function and was calculated as follows: HOMA-B = (20 * fasting insulin (picomoles per liter [pmol/L]) * 1/6(microunit per milliliter [µU/mL]))/ FPG(mmol/L)-3.5). HOMA-beta score ranges from minus infinity to infinity (no limits). Higher score means better beta-cell function for HOMA-beta. Negative change from baseline (week 0) in HOMA-B indicated a worse outcome. The outcome measure was evaluated based on the data from on-treatment observation period. On-treatment observation period: from first administration and up until last trial contact, week 26 or 14 days after last administration, whichever came first. | SAS included all randomized participants exposed to trial product. Overall number of participants analyzed = participants with available data for this outcome measure. | Posted | Mean | Standard Deviation | HOMA-B index | Baseline (week 0); week 26 |
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| Secondary | Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) | Change in HOMA-IR from baseline (week 0) to week 26 is presented. Insulin resistance is a condition in which cells fail to respond to normal actions of hormone in body. HOMA-IR is calculated using a participant's fasting plasma insulin and glucose levels. HOMA-IR = fasting serum insulin (micro international units per milliliter (μU/ml)) × fasting plasma glucose (millimoles per liter (mmol/l)) / 22.5. HOMA-IR scores are classified as follows: less than 1.0: considered insulin sensitive, 0.5-1.4: considered healthy, above 1.8: considered early insulin resistance; above 2.7 is considered significant insulin resistance. HOMA-IR score ranges from 0-infinity (no upper limit). Higher the score, higher the level of insulin resistance. The outcome measure was evaluated based on the data from on-treatment observation period. On-treatment observation period: from first administration and up until last trial contact, week 26 or 14 days after last administration, whichever came first. | SAS included all randomized participants exposed to trial product. | Posted | Mean | Standard Deviation | HOMA-IR index | Baseline (week 0); week 26 |
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| Secondary | Change in Glycated Haemoglobin (HbA1c) | Change in HbA1c from baseline (week 0) to week 26 is presented. The outcome measure was evaluated based on the data from on-treatment observation period. On-treatment observation period: from first administration and up until last trial contact, week 26 or 14 days after last administration, whichever came first. | SAS included all randomized participants exposed to trial product. Overall number of participants analyzed = participants with available data for this outcome measure. | Posted | Mean | Standard Deviation | Percentage of HbA1c | Baseline (week 0); week 26 |
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| Secondary | Change in Insulin-like Growth Factor I (IGF-I) Standard Deviation Score (SDS) | Change in IGF-I SDS from baseline (week 0) to week 26 is presented. IGF-I 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. The range for IGF-I SDS was from -10 to +10. Negative scores indicated a IGF-I below the mean IGF-I for a child with the same age and gender, whereas positive scores indicated a IGF-I above the mean IGF-I for a child with the same age and gender. Positive value in change from baseline in IGF-I SDS indicated that IGF-I SDS was higher than baseline IGF-I SDS. The outcome measure was evaluated based on the data from on-treatment observation period. On-treatment observation period: from first administration and up until last trial contact, week 26 or 14 days after last administration, whichever came first. | FAS included all randomized participants exposed to the trial product. | Posted | Mean | Standard Deviation | score on a scale | Baseline (week 0); week 26 |
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| Secondary | Change in Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) SDS | Change in IGFBP-3 SDS from baseline (week 0) to week 26 is presented. The range for IGFBP-3 SDS was from -10 to +10. Negative scores indicated a IGFBP-3 below the mean IGFBP-3 for a child with the same age and gender, whereas positive scores indicated a IGFBP-3 above the mean IGFBP-3 for a child with the same age and gender. Positive value in change from baseline in IGFBP-3 SDS indicated that IGFBP-3 SDS was higher than baseline IGFBP-3 SDS. The outcome measure was evaluated based on the data from on-treatment observation period. On-treatment observation period: from first administration and up until last trial contact, week 26 or 14 days after last administration, whichever came first. | FAS included all randomized participants exposed to the trial product. | Posted | Mean | Standard Deviation | score on a scale | Baseline (week 0); week 26 |
|
From Baseline (Week 0) to Week 52
All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Norditropin (0.035mg/kg/Day) | Participants received 0.035 mg/kg/day subcutaneous injection of norditropin daily during the main phase (26-week) and extension phase I (26-week). | 0 | 12 | 1 | 12 | 7 | 12 |
| EG001 | Norditropin (0.067mg/kg/Day) | Participants received 0.067 mg/kg/day subcutaneous injection of norditropin daily during the main phase (26-week) and extension phase I (26-week). | 0 | 13 | 0 | 13 | 6 | 13 |
| EG002 | Somapacitan (0.16mg/kg/Week) | Participants received 0.16 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week). | 0 | 12 | 0 | 12 | 7 | 12 |
| EG003 | Somapacitan (0.20mg/kg/Week) | Participants received 0.20 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week). | 0 | 13 | 1 | 13 | 9 | 13 |
| EG004 | Somapacitan (0.24mg/kg/Week) | Participants received 0.24 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week). | 0 | 12 | 0 | 12 | 8 | 12 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Inguinal hernia | Gastrointestinal disorders | MedDRA 24 | Systematic Assessment |
| |
| Type 1 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 24 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA 24 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 24 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 24 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24 | Systematic Assessment |
| |
| Behaviour disorder | Psychiatric disorders | MedDRA 24 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 24 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24 | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA 24 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Enuresis | Psychiatric disorders | MedDRA 24 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 24 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 24 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 24 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 24 | Systematic Assessment |
| |
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA 24 | Systematic Assessment |
| |
| Impaired fasting glucose | Metabolism and nutrition disorders | MedDRA 24 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 24 | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 24 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 24 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 24 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Otitis externa | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Perioral dermatitis | Skin and subcutaneous tissue disorders | MedDRA 24 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Protein urine present | Investigations | MedDRA 24 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 24 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 24 | Systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 24 | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 24 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Varicella | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 24 | Systematic Assessment |
| |
| Vulvovaginal pruritus | Reproductive system and breast disorders | MedDRA 24 | Systematic Assessment |
| |
| Allergy to arthropod bite | Immune system disorders | MedDRA 24 | Systematic Assessment |
| |
| Amblyopia | Eye disorders | MedDRA 24 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 24 | Systematic Assessment |
| |
| Astigmatism | Eye disorders | MedDRA 24 | Systematic Assessment |
| |
| Butterfly rash | Skin and subcutaneous tissue disorders | MedDRA 24 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 24 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 24 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 24 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 24 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Growing pains | Musculoskeletal and connective tissue disorders | MedDRA 24 | Systematic Assessment |
| |
| Hand dermatitis | Skin and subcutaneous tissue disorders | MedDRA 24 | Systematic Assessment |
| |
| Lipoatrophy | Skin and subcutaneous tissue disorders | MedDRA 24 | Systematic Assessment |
| |
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA 24 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 24 | Systematic Assessment |
| |
| Pallor | Vascular disorders | MedDRA 24 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 24 | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24 | Systematic Assessment |
| |
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 24 | Systematic Assessment |
|
At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Reporting Office (2834) | Novo Nordisk A/S | (+1) 866-867-7178 | clinicaltrials@novonordisk.com |
| Apr 26, 2024 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| C000718308 | somapacitan |
| D019382 | Human Growth Hormone |
| ID | Term |
|---|---|
| D013006 | Growth Hormone |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Other |
|
| Not reported |
|
| Treatment difference |
| 0.7 |
| 2-Sided |
| 95 |
| -1.1 |
| 2.5 |
| Superiority |
| Treatment difference | -0.9 | 2-Sided | 95 | -2.6 | 0.9 | Superiority |
| Treatment difference | -0.6 | 2-Sided | 95 | -2.4 | 1.2 | Superiority |
| Somapacitan 0.16 mg/kg/Week |
Participants received 0.16 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week). |
| OG003 | Somapacitan 0.20 mg/kg/Week | Participants received 0.20 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week). |
| OG004 | Somapacitan 0.24 mg/kg/Week | Participants received 0.24 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week). |
|
|
| OG002 | Somapacitan 0.16 mg/kg/Week | Participants received 0.16 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week). |
| OG003 | Somapacitan 0.20 mg/kg/Week | Participants received 0.20 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week). |
| OG004 | Somapacitan 0.24 mg/kg/Week | Participants received 0.24 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week). |
|
|
| OG002 | Somapacitan 0.16 mg/kg/Week | Participants received 0.16 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week). |
| OG003 | Somapacitan 0.20 mg/kg/Week | Participants received 0.20 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week). |
| OG004 | Somapacitan 0.24 mg/kg/Week | Participants received 0.24 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week). |
|
|
| OG003 |
| Somapacitan 0.20 mg/kg/Week |
Participants received 0.20 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week). |
| OG004 | Somapacitan 0.24 mg/kg/Week | Participants received 0.24 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week). |
|
|
| OG002 | Somapacitan 0.16 mg/kg/Week | Participants received 0.16 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week). |
| OG003 | Somapacitan 0.20 mg/kg/Week | Participants received 0.20 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week). |
| OG004 | Somapacitan 0.24 mg/kg/Week | Participants received 0.24 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week). |
|
|
| OG002 | Somapacitan 0.16 mg/kg/Week | Participants received 0.16 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week). |
| OG003 | Somapacitan 0.20 mg/kg/Week | Participants received 0.20 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week). |
| OG004 | Somapacitan 0.24 mg/kg/Week | Participants received 0.24 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week). |
|
|
| OG003 | Somapacitan 0.20 mg/kg/Week | Participants received 0.20 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week). |
| OG004 | Somapacitan 0.24 mg/kg/Week | Participants received 0.24 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week). |
|
|
| OG002 | Somapacitan 0.16 mg/kg/Week | Participants received 0.16 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week). |
| OG003 | Somapacitan 0.20 mg/kg/Week | Participants received 0.20 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week). |
| OG004 | Somapacitan 0.24 mg/kg/Week | Participants received 0.24 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week). |
|
|
| Somapacitan 0.16 mg/kg/Week |
Participants received 0.16 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week). |
| OG003 | Somapacitan 0.20 mg/kg/Week | Participants received 0.20 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week). |
| OG004 | Somapacitan 0.24 mg/kg/Week | Participants received 0.24 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week). |
|
|