MOD-4023 ( DrugBank: - )
1 disease
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 78 | 下垂体前葉機能低下症 | 35 |
78. 下垂体前葉機能低下症
臨床試験数 : 492 / 薬物数 : 341 - (DrugBank : 47) / 標的遺伝子数 : 45 - 標的パスウェイ数 : 100
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | JPRN-JapicCTI-183963 | 25/12/2017 | 17/05/2018 | Safety and Efficacy Study of MOD-4023 to Treat Children With Growth Hormone Deficiency | A PHASE 3, OPEN-LABEL, RANDOMIZED, MULTICENTER, 12-MONTH, EFFICACY AND SAFETY STUDY OF WEEKLY MOD-4023 COMPARED TO DAILY GENOTROPIN THERAPY IN JAPANESE PRE-PUBERTAL CHILDREN WITH GROWTH HORMONE DEFICIENCY | Treatment of children with growth failure due to growth hormone deficiency (GHD) | Intervention name : Somatrogon (Genetical Recombination) INN of the intervention : somatrogon Dosage And administration of the intervention : MOD-4023 (investigational treatment): weekly MOD-4023 SC injections for 12 months; initially over the first 6 weeks, MOD-4023 will be administered in 3 stepwise escalating doses (0.25 mg/kg/week, 0.48 mg/kg/week and 0.66 mg/kg/week), each for two weeks sequentially. For the remaining 46 weeks, patients will continue to receive MOD-4023 at a dose of 0.66 mg/kg/week. Control intervention name : Genotropin INN of the control intervention : somatropin Dosage And administration of the control intervention : Daily SC injections Genotropin (0.025 mg/kg/day). | OPKO Health Inc.(ICCC: EPS International Holdings Co., Ltd) | NULL | complete | 3 | 11 | BOTH | 44 | Phase 3 | Japan |
| 2 | EUCTR2016-003874-42-GR (EUCTR) | 20/12/2017 | 21/11/2017 | An efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency | A phase 3, open-label, randomized, multicenter, 12 months, efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency - N/A | Growth hormone deficiency in pre-pubertal children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: MOD-4023 INN or Proposed INN: Somatrogon Product Code: MOD-4023 INN or Proposed INN: Somatrogon Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION | OPKO Biologics Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 220 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Belarus;Taiwan;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;Colombia;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Romania;Australia;Georgia;Bulgaria;Germany;New Zealand | ||
| 3 | NCT03874013 (ClinicalTrials.gov) | December 7, 2017 | 1/10/2018 | Safety and Efficacy Study of MOD-4023 to Treat Children With Growth Hormone Deficiency | A Phase 3, Open-Label, Randomized, Multicenter, 12-month, Efficacy and Safety Study of Weekly MOD-4023 Compared to Daily Genotropin® Therapy in Japanese Pre-pubertal Children With Growth Hormone Deficiency | Growth Hormone Deficiency | Drug: MOD-4023;Drug: Genotropin | OPKO Health, Inc. | NULL | Completed | 3 Years | 11 Years | All | 44 | Phase 3 | Japan |
| 4 | EUCTR2016-003874-42-GB (EUCTR) | 04/09/2017 | 03/01/2017 | An efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency | A phase 3, open-label, randomized, multicenter, 12 months, efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency - N/A | Growth hormone deficiency in pre-pubertal children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: MOD-4023 INN or Proposed INN: Somatrogon Product Code: MOD-4023 INN or Proposed INN: Somatrogon Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION | OPKO Biologics Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 220 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Taiwan;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;Colombia;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Romania;Australia;Georgia;Bulgaria;Germany;New Zealand;United States;Belarus | ||
| 5 | EUCTR2016-003874-42-DE (EUCTR) | 04/08/2017 | 01/02/2017 | An efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency | A phase 3, open-label, randomized, multicenter, 12 months, efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency - N/A | Growth hormone deficiency in pre-pubertal children MedDRA version: 19.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: MOD-4023 INN or Proposed INN: Somatrogon Product Code: MOD-4023 INN or Proposed INN: Somatrogon Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION | OPKO Biologics Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 220 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Belarus;United States;Taiwan;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;Vietnam;India;France;Australia;Netherlands;Turkey;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Romania;Bulgaria;Georgia;Germany;New Zealand | ||
| 6 | EUCTR2016-003874-42-IT (EUCTR) | 16/06/2017 | 06/09/2021 | An efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency | A phase 3, open-label, randomized, multicenter, 12 months, efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency - N/A | Growth hormone deficiency in pre-pubertal children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: MOD-4023 INN or Proposed INN: Somatrogon Product Code: MOD-4023 INN or Proposed INN: Somatrogon Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin | PRM|21097 | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 220 | Phase 3 | France;Greece;Spain;Poland;Bulgaria;Germany;United Kingdom;Italy | ||
| 7 | EUCTR2016-003874-42-ES (EUCTR) | 18/05/2017 | 14/03/2017 | An efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency | A phase 3, open-label, randomized, multicenter, 12 months, efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency - N/A | Growth hormone deficiency in pre-pubertal children MedDRA version: 19.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: MOD-4023 INN or Proposed INN: Somatrogon Product Code: MOD-4023 INN or Proposed INN: Somatrogon Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION | OPKO Biologics Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 220 | Phase 3 | Serbia;Belarus;United States;Taiwan;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;Vietnam;India;France;Australia;Netherlands;Turkey;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Romania;Bulgaria;Georgia;Germany;New Zealand | ||
| 8 | EUCTR2016-003874-42-BG (EUCTR) | 26/04/2017 | 13/02/2017 | An efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency | A phase 3, open-label, randomized, multicenter, 12 months, efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency - N/A | Growth hormone deficiency in pre-pubertal children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: MOD-4023 INN or Proposed INN: Somatrogon Product Code: MOD-4023 INN or Proposed INN: Somatrogon Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION | OPKO Biologics Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 220 | Phase 3 | United States;Belarus;Taiwan;Greece;Spain;Ukraine;Turkey;Israel;Russian Federation;Colombia;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Australia;Bulgaria;Georgia;Germany;New Zealand | ||
| 9 | NCT02968004 (ClinicalTrials.gov) | December 2016 | 13/11/2016 | Safety and Efficacy Phase 3 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children | A Phase 3, Open-label, Randomized, Multicenter, 12 Months, Efficacy and Safety Study of Weekly MOD-4023 Compared to Daily Genotropin - Therapy in Pre-pubertal Children With Growth Hormone Deficiency | Pediatric Growth Hormone Deficiency | Drug: MOD-4023;Drug: Somatropin | OPKO Health, Inc. | NULL | Active, not recruiting | 3 Years | 11 Years | All | 224 | Phase 3 | United States;Argentina;Australia;Belarus;Bulgaria;Canada;Colombia;Georgia;Greece;India;Israel;Korea, Republic of;Mexico;New Zealand;Poland;Russian Federation;Spain;Taiwan;Ukraine;United Kingdom;Germany;Italy;Turkey |
| 10 | NCT02418767 (ClinicalTrials.gov) | January 2015 | 8/1/2015 | Pharmacokinetics and Pharmacodynamics of Long Acting Human Growth Hormone (hGH) Product (MOD-4023) in Healthy Caucasian and Japanese Volunteers | A Randomized, Double-blind, Vehicle-controlled, Parallel Group, Single Dose Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Three Doses of Long Acting HGH Product (MOD-4023) in Healthy Caucasian and Japanese Volunteers | Growth Hormone Deficiency | Drug: MOD-4023;Drug: Placebo | OPKO Health, Inc. | WCCT Global | Completed | 18 Years | 45 Years | Male | 42 | Phase 1 | United States |
| 11 | EUCTR2013-000830-37-PL (EUCTR) | 11/06/2014 | 03/01/2014 | Treatment with Long Acting hGH Product in Adult subjects with Growth Hormone Deficiency | A Phase 3, Multicenter Study Designed to Evaluate the Efficacy and Safety of a Long Acting hGH Product (MOD-4023) in Adult Subjects with Growth Hormone Deficiency | Adult or childhood onset growth hormone deficiency (GHD) MedDRA version: 19.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE | OPKO Biologics Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 189 | Phase 3 | Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Poland;Romania;Australia;Georgia;Netherlands;Germany;Korea, Republic of | ||
| 12 | EUCTR2013-000830-37-NL (EUCTR) | 02/01/2014 | 29/07/2013 | Treatment with Long Acting hGH Product in Adult subjects with Growth Hormone Deficiency | A Phase 3, Multicenter Study Designed to Evaluate the Efficacy and Safety of a Long Acting hGH Product (MOD-4023) in Adult Subjects with Growth Hormone Deficiency | Adult or childhood onset growth hormone deficiency (GHD) MedDRA version: 17.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE | OPKO Biologics Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 189 | Phase 3 | United States;Serbia;Slovakia;Greece;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;France;Hungary;Poland;Romania;Netherlands;Germany | ||
| 13 | EUCTR2013-000830-37-ES (EUCTR) | 12/10/2013 | 12/07/2013 | Treatment with Long Acting hGH Product in Adult subjects with Growth Hormone Deficiency | A Phase 3, Multicenter Study Designed to Evaluate the Efficacy and Safety of a Long Acting hGH Product (MOD-4023) in Adult Subjects with Growth Hormone Deficiency | Adult or childhood onset growth hormone deficiency (GHD) MedDRA version: 16.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE | PROLOR Biotech Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 189 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Slovakia;Greece;Spain;Ukraine;Austria;Israel;Russian Federation;Italy;United Kingdom;France;Hungary;Poland;Romania;Netherlands;Germany | ||
| 14 | EUCTR2013-000830-37-GB (EUCTR) | 30/09/2013 | 09/07/2013 | Treatment with Long Acting hGH Product in Adult subjects with Growth Hormone Deficiency | A Phase 3, Multicenter Study Designed to Evaluate the Efficacy and Safety of a Long Acting hGH Product (MOD-4023) in Adult Subjects with Growth Hormone Deficiency | Adult or childhood onset growth hormone deficiency (GHD) MedDRA version: 17.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE | OPKO Biologics Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 190 | Phase 3 | United States;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Armenia;Poland;Romania;Australia;Georgia;Germany;Netherlands;Korea, Republic of | ||
| 15 | EUCTR2013-000830-37-GR (EUCTR) | 12/09/2013 | 03/07/2013 | Treatment with Long Acting hGH Product in Adult subjects with Growth Hormone Deficiency | A Phase 3, Multicenter Study Designed to Evaluate the Efficacy and Safety of a Long Acting hGH Product (MOD-4023) in Adult Subjects with Growth Hormone Deficiency | Adult or childhood onset growth hormone deficiency (GHD) MedDRA version: 16.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE | PROLOR Biotech Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 189 | Phase 3 | United States;Serbia;Slovakia;Greece;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Poland;Romania;Germany;Netherlands | ||
| 16 | EUCTR2013-000830-37-SK (EUCTR) | 04/09/2013 | 24/05/2013 | Treatment with Long Acting hGH Product in Adult subjects with Growth Hormone Deficiency | A Phase 3, Multicenter Study Designed to Evaluate the Efficacy and Safety of a Long Acting hGH Product (MOD-4023) in Adult Subjects with Growth Hormone Deficiency | Adult or childhood onset growth hormone deficiency (GHD) MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE | OPKO Biologics Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 189 | Phase 3 | United States;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;France;Hungary;Poland;Romania;Australia;Georgia;Netherlands;Germany;Korea, Republic of | ||
| 17 | EUCTR2013-000830-37-AT (EUCTR) | 29/08/2013 | 11/07/2013 | Treatment with Long Acting hGH Product in Adult subjects with Growth Hormone Deficiency | A Phase 3, Multicenter Study Designed to Evaluate the Efficacy and Safety of a Long Acting hGH Product (MOD-4023) in Adult Subjects with Growth Hormone Deficiency | Adult or childhood onset growth hormone deficiency (GHD) MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE | OPKO Biologics Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 190 | Phase 3 | Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Poland;Romania;Australia;Georgia;Netherlands;Germany;Korea, Republic of | ||
| 18 | EUCTR2013-000830-37-HU (EUCTR) | 03/07/2013 | 23/05/2013 | Treatment with Long Acting hGH Product in Adult subjects with Growth Hormone Deficiency | A Phase 3, Multicenter Study Designed to Evaluate the Efficacy and Safety of a Long Acting hGH Product (MOD-4023) in Adult Subjects with Growth Hormone Deficiency | Adult or childhood onset growth hormone deficiency (GHD) MedDRA version: 19.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE | OPKO Biologics Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 189 | Phase 3 | Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Poland;Romania;Australia;Georgia;Netherlands;Germany;Korea, Republic of | ||
| 19 | EUCTR2011-004553-60-PL (EUCTR) | 02/04/2013 | 09/02/2012 | A study of MOD-4023 compared with daily GH therapy in children with lack of growth hormone in the body | Safety and dose finding study of different MOD-4023 dose levelscompared to daily r-hGH therapy in pre-pubertal growth hormonedeficient children | Pediatric Growth Hormone Deficiency MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: no INN available yet Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: no INN available yet Trade Name: Genotropin Product Name: Recombinant human Growth Hormone INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone produced in E.coli | OPKO Biologics Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 56 | United States;Belarus;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Czech Republic;Hungary;Poland;Romania;Bulgaria;Georgia | |||
| 20 | NCT02500316 (ClinicalTrials.gov) | February 2013 | 12/7/2015 | Long Term Follow up Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children | Safety and Dose Finding Study of Different MOD-4023 Dose Levels Compared to Daily R-human Growth Hormone (hGH) Therapy in Pre-pubertal Growth Hormone Deficient Children | Growth Hormone Deficiency (GHD) | Drug: MOD-4023 | OPKO Health, Inc. | NULL | Active, not recruiting | 3 Years | 11 Years | All | 48 | Phase 2 | United States;Belarus;Greece;Hungary;Russian Federation;Ukraine;Slovakia |
| 21 | EUCTR2011-004553-60-BG (EUCTR) | 02/07/2012 | 10/04/2012 | A study of MOD-4023 compared with daily GH therapy in children with lack of growth hormone in the body | Safety and dose finding study of different MOD-4023 dose levelscompared to daily r-hGH therapy in pre-pubertal growth hormonedeficient children | Pediatric Growth Hormone Deficiency MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: not available yet Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: not available yet Trade Name: Genotropin Product Name: Recombinant human Growth Hormone INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone produced in E.coli | OPKO Biologics Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 56 | United States;Belarus;Slovakia;Greece;Ukraine;Israel;Russian Federation;Czech Republic;Hungary;Poland;Romania;Bulgaria;Georgia | |||
| 22 | EUCTR2011-004553-60-CZ (EUCTR) | 10/04/2012 | 06/12/2011 | A study of MOD-4023 compared with daily GH therapy in children with lack of growth hormone in the body | Safety and dose finding study of different MOD-4023 dose levelscompared to daily r-hGH therapy in pre-pubertal growth hormonedeficient children | Pediatric Growth Hormone Deficiency MedDRA version: 14.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: not available yet Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: not available yet Trade Name: Genotropin Product Name: Recombinant human Growth Hormone INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone produced in E.coli | PROLOR Biotech Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 56 | United States;Belarus;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Czech Republic;Hungary;Poland;Romania;Bulgaria;Georgia | |||
| 23 | NCT01592500 (ClinicalTrials.gov) | February 2012 | 2/5/2012 | Safety and Efficacy Phase 2 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children | Safety and Dose Finding Study of Different MOD-4023 Dose Levels Compared to Daily r-hGH Therapy in Pre-pubertal Growth Hormone Deficient Children | Pediatric Growth Hormone Deficiency | Drug: MOD-4023;Drug: Somatropin | OPKO Health, Inc. | NULL | Completed | 3 Years | 11 Years | All | 56 | Phase 2 | Greece;Hungary;Slovakia |
| 24 | EUCTR2011-004553-60-GR (EUCTR) | 23/01/2012 | 27/12/2011 | A study of MOD-4023 compared with daily GH therapy in children with lack of growth hormone in the body | Safety and dose finding study of different MOD-4023 dose levelscompared to daily r-hGH therapy in pre-pubertal growth hormonedeficient children | Pediatric Growth Hormone Deficiency MedDRA version: 14.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: n/a Product Code: MOD-4023 Product Name: n/a Product Code: MOD-4023 Trade Name: Genotropin Product Name: Recombinant human Growth Hormone INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone produced in E.coli | PROLOR Biotech Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 56 | Hungary;Czech Republic;Russian Federation;Ukraine;Belarus;Greece;Macedonia, the former Yugoslav Republic of;Israel | |||
| 25 | EUCTR2011-004553-60-HU (EUCTR) | 10/01/2012 | 03/11/2011 | A study of MOD-4023 compared with daily GH therapy in children with lack of growth hormone in the body | Safety and dose finding study of different MOD-4023 dose levelscompared to daily r-hGH therapy in pre-pubertal growth hormonedeficient children | Pediatric Growth Hormone Deficiency;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: not available Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: not available Trade Name: Genotropin Product Name: Recombinant human Growth Hormone INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone produced in E.coli | OPKO Biologics Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 56 | Phase 2 | Belarus;United States;Czech Republic;Hungary;Slovakia;Greece;Poland;Ukraine;Bulgaria;Russian Federation | ||
| 26 | EUCTR2011-004553-60-SK (EUCTR) | 10/01/2012 | 24/11/2011 | A study of MOD-4023 compared with daily GH therapy in children with lack of growth hormone in the body | Safety and dose finding study of different MOD-4023 dose levelscompared to daily r-hGH therapy in pre-pubertal growth hormonedeficient children | Pediatric Growth Hormone Deficiency MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: Not available yet Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: Not available yet Trade Name: Genotropin Product Name: Recombinant human Growth Hormone INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone produced in E.coli | OPKO Biologics Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 56 | United States;Belarus;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Czech Republic;Hungary;Poland;Romania;Bulgaria;Georgia | |||
| 27 | EUCTR2010-019374-32-AT (EUCTR) | 15/02/2011 | 29/12/2010 | A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) | A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) | Growth Hormone Deficiency MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Name: n/a Product Code: MOD-4023 Trade Name: Only medicinal products registered in Austria will be used in this clinical trial. Product Name: recombinant human Growth Hormone (rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone | ModigeneTech Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 56 | Phase 2 | Czech Republic;Hungary;Slovenia;Slovakia;Austria;Germany | ||
| 28 | EUCTR2010-019374-32-HU (EUCTR) | 13/09/2010 | 18/05/2010 | A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) | A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) | Growth Hormone Deficiency MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Name: n/a Product Code: MOD-4023 Trade Name: Genotropin Product Name: recombinant human Growth Hormone (rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone produced in E.coli Trade Name: Humatrope Product Name: recombinant human Growth Hormone(rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli Trade Name: Norditropin Simplex Product Name: recombinant human Growth Hormone(rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli Trade Name: Saizen Product Name: recombinant human Growth Hormone(rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli Trade Name: NutropinAq Product Name: recombinant human Growth Hormone(rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinanat DNA-derived human growth | ModigeneTech Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 56 | Phase 2 | Hungary;Germany;Czech Republic;Slovakia;Slovenia | ||
| 29 | EUCTR2010-019374-32-SI (EUCTR) | 13/09/2010 | 04/06/2010 | A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) | A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) | Growth Hormone Deficiency MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Name: n/a Product Code: MOD-4023 Trade Name: Genotropin Product Name: recombinant human Growth Hormone (rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone produced in E.coli Trade Name: Humatrope Product Name: recombinant human Growth Hormone(rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli Trade Name: Norditropin Simplex Product Name: recombinant human Growth Hormone(rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli Trade Name: NutropinAq Product Name: recombinant human Growth Hormone(rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli Trade Name: Omnitrop Product Name: recombinant human Growth Hormone(rhGH) INN or Proposed INN: somatropin Other descriptive name: ecombinanat DNA-derived human growth h | ModigeneTech Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 56 | Phase 2 | Hungary;Germany;Czech Republic;Slovakia;Slovenia | ||
| 30 | EUCTR2010-019374-32-CZ (EUCTR) | 06/09/2010 | 15/06/2010 | A study with MOD-4023 in patients with lack of Growth Hormone in the body | A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) | Growth Hormone Deficiency MedDRA version: 14.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: n/a Product Code: MOD-4023 Product Name: recombinant human Growth Hormone (rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone | Prolor Biotech Ltd | NULL | Not Recruiting | Female: yes Male: yes | 56 | Phase 2 | Hungary;Germany;Slovakia;Czech Republic;Serbia;Slovenia;Israel | ||
| 31 | NCT01225666 (ClinicalTrials.gov) | August 2010 | 19/10/2010 | MOD-4023 (Long-Lasting Human Growth Hormone (hGH)) Study in Growth Hormone Deficient Adults (GHDA) | A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) | Adult Growth Hormone Deficiency | Drug: MOD-4023 | OPKO Health, Inc. | NULL | Completed | 23 Years | 60 Years | All | 52 | Phase 2 | Czechia;Hungary;Israel;Serbia;Slovakia;Slovenia;Czech Republic |
| 32 | EUCTR2010-019374-32-SK (EUCTR) | 15/07/2010 | 14/05/2010 | A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) | A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) | Growth Hormone Deficiency MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Name: n/a Product Code: MOD-4023 Trade Name: Genotropin Product Name: recombinant human Growth Hormone (rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone produced in E.coli Trade Name: Humatrope Product Name: recombinant human Growth Hormone(rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli Trade Name: Norditropin Simplex Product Name: recombinant human Growth Hormone(rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli Trade Name: Saizen Product Name: recombinant human Growth Hormone(rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli Trade Name: NutropinAq Product Name: recombinant human Growth Hormone(rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinanat DNA-derived human growth | ModigeneTech Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 56 | Phase 2 | Hungary;Germany;Czech Republic;Slovakia;Slovenia | ||
| 33 | EUCTR2016-003874-42-FR (EUCTR) | 06/03/2017 | An efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency | A phase 3, open-label, randomized, multicenter, 12 months, efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency - N/A | Growth hormone deficiency in pre-pubertal children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: MOD-4023 INN or Proposed INN: Somatrogon Product Code: MOD-4023 INN or Proposed INN: Somatrogon Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION | OPKO Biologics Ltd. | NULL | NA | Female: yes Male: yes | 220 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Belarus;United States;Taiwan;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;Vietnam;India;France;Australia;Netherlands;Turkey;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Romania;Bulgaria;Georgia;Germany;New Zealand | |||
| 34 | EUCTR2010-019374-32-DE (EUCTR) | 07/12/2010 | A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) | A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) | Growth Hormone Deficiency MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Name: n/a Product Code: MOD-4023 Trade Name: Only medicinal products registered in Germany will be used in this clinical trial Product Name: recombinant human Growth Hormone (rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone | ModigeneTech Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 56 | Phase 2 | Hungary;Czech Republic;Slovakia;Germany;Slovenia | |||
| 35 | EUCTR2016-003874-42-PL (EUCTR) | 14/03/2017 | An efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency | A phase 3, open-label, randomized, multicenter, 12 months, efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency - N/A | Growth hormone deficiency in pre-pubertal children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: MOD-4023 INN or Proposed INN: Somatrogon Product Code: MOD-4023 INN or Proposed INN: Somatrogon Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION | OPKO Biologics Ltd. | NULL | NA | Female: yes Male: yes | 220 | Phase 3 | United States;Belarus;Taiwan;Greece;Spain;Ukraine;Turkey;Israel;Russian Federation;Colombia;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Australia;Bulgaria;Georgia;Germany;New Zealand |