LB03002 ( 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26

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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2005-000384-26-FR
(EUCTR)
12/10/201504/10/2005A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency.A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. growth hormone deficiency in adults
MedDRA version: 8.0;Level: PT;Classification code 10056438
Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)
BioPartners GmbHNULLNot Recruiting Female: yes
Male: yes
138 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Czech Republic;Slovakia;Spain;Austria;Germany;United Kingdom;Sweden
2EUCTR2006-002278-24-SE
(EUCTR)
15/05/200705/03/2007A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency.A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. Growth hormone deficiency in adults
MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)
BioPartners GmbHNULLNot RecruitingFemale: yes
Male: yes
150Phase 3United Kingdom;Czech Republic;Germany;France;Spain;Italy;Austria;Sweden
3EUCTR2006-002278-24-GB
(EUCTR)
02/05/200723/11/2006 A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. Growth hormone deficiency in adults
MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)
BioPartners GmbHNULLNot Recruiting Female: yes
Male: yes
150 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Czech Republic;Slovakia;Spain;Austria;Germany;United Kingdom;Sweden
4EUCTR2006-002278-24-SK
(EUCTR)
20/04/200722/03/2007A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency.A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. Growth hormone deficiency in adults
MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)
LG Life Sciences Ltd.BioPartners GmbHNot RecruitingFemale: yes
Male: yes
150Phase 3France;Czech Republic;Slovakia;Spain;Austria;Germany;United Kingdom;Sweden
5EUCTR2006-002278-24-FR
(EUCTR)
13/04/200724/11/2006A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency.A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. Growth hormone deficiency in adults
MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)
BioPartners GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3United Kingdom;Czech Republic;Germany;France;Spain;Italy;Austria;Sweden
6EUCTR2006-002278-24-IT
(EUCTR)
05/04/200716/12/2008A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. - BPLG-005-ROA phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. - BPLG-005-RO Growth hormone deficiency
MedDRA version: 9.1;Level: HLT;Classification code 10002701;Term: Anterior pituitary hypofunction
Product Name: LB03002
INN or Proposed INN: sustained release growth hormone
BIOPARTNERS GMBHNULLNot RecruitingFemale: yes
Male: yes
150Phase 3United Kingdom;Czech Republic;Germany;France;Spain;Italy;Austria;Sweden
7EUCTR2006-002278-24-AT
(EUCTR)
05/01/200710/11/2006A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency.A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. Growth hormone deficiency in adults
MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)
LG Life Sciences Ltd.BioPartners GmbHNot RecruitingFemale: yes
Male: yes
150Phase 3United Kingdom;Czech Republic;Germany;France;Spain;Italy;Austria;Sweden
8EUCTR2005-000346-36-LT
(EUCTR)
29/12/200624/10/2006A Phase III, Multi-centre, Randomised, Parallel Group Study of Safety and Efficacy of the LB03002 a New Sustained Release Formulation of Human Recombinant Growth Hormone as Compared to Standard Daily Therapy with Genotropin® in Treatment Naive Children with Growth Failure due to Insufficient Secretion of Endogenous Growth HormoneA Phase III, Multi-centre, Randomised, Parallel Group Study of Safety and Efficacy of the LB03002 a New Sustained Release Formulation of Human Recombinant Growth Hormone as Compared to Standard Daily Therapy with Genotropin® in Treatment Naive Children with Growth Failure due to Insufficient Secretion of Endogenous Growth Hormone pre-pubertal drug naïve growth-deficient children with insufficient endogenous growth hormone secretion
MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)
Trade Name: Genotropin
Product Name: Genotropin
Product Code: Genotropin
INN or Proposed INN: Somatropin
BioPartners GmbHNULLNot RecruitingFemale: yes
Male: yes
144Phase 3Hungary;Finland;Germany;Czech Republic;Estonia;Italy;Latvia;Austria;Sweden;Lithuania
9EUCTR2006-002278-24-CZ
(EUCTR)
14/12/200608/09/2006A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency.A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. Growth hormone deficiency in adults
MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)
BioPartners GmbHNULLNot RecruitingFemale: yes
Male: yes
150Phase 3United Kingdom;Germany;Czech Republic;France;Spain;Italy;Austria;Sweden
10EUCTR2006-002278-24-ES
(EUCTR)
13/12/200610/03/2010Estudio en fase III, abierto, no controlado, multicéntrico y de continuidad terapéutica, para evaluar la seguridad y la eficacia de LB03002 administrado una vez a la semana en adultos con deficiencia de la hormona de crecimiento.A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency.Estudio en fase III, abierto, no controlado, multicéntrico y de continuidad terapéutica, para evaluar la seguridad y la eficacia de LB03002 administrado una vez a la semana en adultos con deficiencia de la hormona de crecimiento.A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. Growth hormone deficiency in adults
MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)
BioPartners GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3United Kingdom;Czech Republic;Germany;France;Spain;Italy;Austria;Sweden
11EUCTR2006-002278-24-DE
(EUCTR)
06/10/200615/08/2006A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency.A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. Growth hormone deficiency in adults
MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)
BioPartners GmbHNULLNot RecruitingFemale: yes
Male: yes
150Phase 3United Kingdom;Czech Republic;Germany;France;Spain;Italy;Austria;Sweden
12NCT00596037
(ClinicalTrials.gov)
August 20067/1/2008Treatment of Adults With Growth Hormone DeficiencyA Phase III, Open-label, Uncontrolled, Multicentre, Rollover Study to Assess Safety and Efficacy of LB03002 Administered Weekly in Adults With Growth Hormone DeficiencyPituitary Disorders;Adult Growth Hormone DeficiencyDrug: Growth hormone - LB03002LG Life SciencesBioPartners GmbHCompleted23 Years70 YearsBoth136Phase 3United States
13NCT00294619
(ClinicalTrials.gov)
April 200620/2/2006Treatment of Adults With Growth Hormone DeficiencyA Phase III, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter Study to Assess Efficacy and Safety of LB03002 Administered Weekly in Adults With Growth Hormone Deficiency.Pituitary Disorders;Adult Growth Hormone DeficiencyDrug: growth hormoneLG Life SciencesBioPartners GmbHCompleted23 Years70 YearsBoth147Phase 3United States
14EUCTR2005-000384-26-IT
(EUCTR)
23/03/200602/09/2005A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiencyA phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency Growth hormone deficiency in adult
MedDRA version: 6.1;Level: PT;Classification code 10056438
Product Code: LB03002
INN or Proposed INN: Somatropin
BIOPARTNERS GMBHNULLNot RecruitingFemale: yes
Male: yes
Phase 3Germany;United Kingdom;Czech Republic;Spain;Italy;Sweden
15EUCTR2005-000384-26-DE
(EUCTR)
20/12/200502/06/2006A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency.A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. Growth hormone deficiency in adults
MedDRA version: 8.0;Level: PT;Classification code 10056438
Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)
BioPartners GmbHNULLNot RecruitingFemale: yes
Male: yes
150Phase 3United Kingdom;Czech Republic;Germany;Spain;Sweden
16EUCTR2005-000384-26-AT
(EUCTR)
10/11/200510/06/2005A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency.A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. growth hormone deficiency in adults
MedDRA version: 8.0;Level: PT;Classification code 10056438
Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)
LG Life Science Ltd.BioPartnersNot RecruitingFemale: yes
Male: yes
138Phase 3Czech Republic;Spain;Austria;Germany;United Kingdom;Sweden
17EUCTR2005-000384-26-SK
(EUCTR)
27/10/200519/09/2005A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency.A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. growth hormone deficiency in adults
MedDRA version: 8.0;Level: PT;Classification code 10056438
Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)
BioPartners GmbHNULLNot RecruitingFemale: yes
Male: yes
138Phase 3Czech Republic;Slovakia;Spain;Austria;Germany;United Kingdom;Sweden
18EUCTR2005-000384-26-GB
(EUCTR)
21/10/200517/08/2005A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency.A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. growth hormone deficiency in adults
MedDRA version: 8.0;Level: PT;Classification code 10056438
Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)
BioPartners GmbHNULLNot Recruiting Female: yes
Male: yes
150 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Czech Republic;Slovakia;Spain;Austria;Germany;United Kingdom;Sweden
19EUCTR2005-000384-26-CZ
(EUCTR)
30/09/200508/08/2005A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency.A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. Growth hormone deficiency in adults
MedDRA version: 8.0;Level: PT;Classification code 10056438
Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)
BioPartners GmbHNULLNot RecruitingFemale: yes
Male: yes
150Phase 3Germany;United Kingdom;Czech Republic;Spain;Sweden
20EUCTR2005-000346-36-FI
(EUCTR)
22/09/200530/05/2005A Phase III, Multi-centre, Randomised, Parallel Group Study of Safety and Efficacy of the LB03002 a New Sustained Release Formulation of Human Recombinant Growth Hormone as Compared to Standard Daily Therapy with Genotropin® in Treatment Naive Children with Growth Failure due to Insufficient Secretion of Endogenous Growth HormoneA Phase III, Multi-centre, Randomised, Parallel Group Study of Safety and Efficacy of the LB03002 a New Sustained Release Formulation of Human Recombinant Growth Hormone as Compared to Standard Daily Therapy with Genotropin® in Treatment Naive Children with Growth Failure due to Insufficient Secretion of Endogenous Growth Hormone pre-pubertal drug naïve growth-deficient children with insufficient endogenous growth hormone secretion
MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)
Trade Name: Genotropin
Product Name: Genotropin
Product Code: Genotropin
INN or Proposed INN: Somatropin
BioPartners GmbHNULLNot RecruitingFemale: yes
Male: yes
144Phase 3Hungary;Finland;Germany;Czech Republic;Estonia;Italy;Latvia;Austria;Lithuania;Sweden
21EUCTR2005-000384-26-SE
(EUCTR)
13/09/200527/06/2005A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency.A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. Growth hormone deficiency in adults
MedDRA version: 8.0;Level: PT;Classification code 10056438
Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)
BioPartners GmbHNULLNot RecruitingFemale: yes
Male: yes
150Phase 3Germany;United Kingdom;Czech Republic;Spain;Sweden
22NCT00271518
(ClinicalTrials.gov)
September 200529/12/2005Treatment of Children With Insufficient Secretion of Growth HormoneA Phase III, Multi-centre, Randomised, Parallel Group Study of Safety and Efficacy of the LB03002 a New Sustained Release Formulation of Human Recombinant Growth Hormone as Compared to Standard Daily Therapy in Treatment Naive Children With Growth Failure Due to Insufficient Secretion of Endogenous Growth HormoneGrowth Hormone Deficiency (GHD)Drug: growth hormone (somatropin)LG Life SciencesBioPartners GmbHActive, not recruiting3 Years11 YearsBoth144Phase 3United States
23EUCTR2005-000384-26-ES
(EUCTR)
22/08/200527/06/2005A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency.Estudio de fase III, en doble ciego, aleatorizado, controlado con placebo, de grupos paralelos y multicéntrico, para evaluar la eficacia y la seguridad de LB03002 administrado una vez a la semana en adultos con deficiencia de hormona del crecimientoA phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency.Estudio de fase III, en doble ciego, aleatorizado, controlado con placebo, de grupos paralelos y multicéntrico, para evaluar la eficacia y la seguridad de LB03002 administrado una vez a la semana en adultos con deficiencia de hormona del crecimiento growth hormone deficiency in adults
MedDRA version: 8.0;Level: PT;Classification code 10056438
Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)
LG Life Science Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
138Phase 3Germany;United Kingdom;Czech Republic;Spain;Sweden
24EUCTR2005-000346-36-SE
(EUCTR)
18/08/200516/06/2005A Phase III, Multi-centre, Randomised, Parallel Group Study of Safety and Efficacy of the LB03002 a New Sustained Release Formulation of Human Recombinant Growth Hormone as Compared to Standard Daily Therapy with Genotropin® in Treatment Naive Children with Growth Failure due to Insufficient Secretion of Endogenous Growth HormoneA Phase III, Multi-centre, Randomised, Parallel Group Study of Safety and Efficacy of the LB03002 a New Sustained Release Formulation of Human Recombinant Growth Hormone as Compared to Standard Daily Therapy with Genotropin® in Treatment Naive Children with Growth Failure due to Insufficient Secretion of Endogenous Growth Hormone pre-pubertal drug naïve growth-deficient children with insufficient endogenous growth hormone secretion
MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)
Trade Name: Genotropin
Product Name: Genotropin
Product Code: Genotropin
INN or Proposed INN: Somatropin
BioPartners GmbHNULLNot RecruitingFemale: yes
Male: yes
144Phase 3Hungary;Finland;Germany;Czech Republic;Estonia;Italy;Latvia;Austria;Lithuania;Sweden
25EUCTR2005-000346-36-DE
(EUCTR)
16/08/200506/06/2006A Phase III, Multi-centre, Randomised, Parallel Group Study of Safety and Efficacy of the LB03002 a New Sustained Release Formulation of Human Recombinant Growth Hormone as Compared to Standard Daily Therapy with Genotropin® in Treatment Naive Children with Growth Failure due to Insufficient Secretion of Endogenous Growth HormoneA Phase III, Multi-centre, Randomised, Parallel Group Study of Safety and Efficacy of the LB03002 a New Sustained Release Formulation of Human Recombinant Growth Hormone as Compared to Standard Daily Therapy with Genotropin® in Treatment Naive Children with Growth Failure due to Insufficient Secretion of Endogenous Growth Hormone pre-pubertal drug naïve growth-deficient children with insufficient endogenous growth hormone secretion
MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)
Trade Name: Genotropin
Product Name: Genotropin
Product Code: Genotropin
INN or Proposed INN: Somatropin
BioPartners GmbHNULLNot RecruitingFemale: yes
Male: yes
180Phase 3Hungary;Finland;Czech Republic;Germany;Estonia;Italy;Latvia;Austria;Lithuania;Sweden
26NCT00600808
(ClinicalTrials.gov)
June 200323/7/2007Sustained Release Formulation of Somatropin (rDNA Origin)for InjectionA Phase II/IIIa, Assessor Blinded (Partially Blinded), Randomised, Active-Controlled, Multicentre, Parallel-Group Study of the Safety, Efficacy and pk/pd of LB03002 Administered Weekly in Children With Growth Failure Due to GH Deficiency.Growth Hormone DeficiencyDrug: BPLG-003BioPartners GmbHLG Life SciencesCompleted4 Years10 YearsBoth51Phase 2/Phase 3NULL