ID
38601
Beschreibung
Study ID: 110951 Clinical Study ID: 110951 Study Title: A two-part, randomised, placebo-controlled study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single doses of intravenously infused GSK1995057 in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01476046 See https://clinicaltrials.gov/ct2/show/NCT01476046 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: N/A, Placebo Trade Name: N/A Study Indication: Respiratory Disorders The single-centre study consists of two parts A and B with seven cohorts/ten subcohorts in total. Part A includes ascending doses of the investigational product given to subjects negative or positive for pre-existing human anti-heavy chain variable domain (HAVH) antibodies (Cohorts 1 to 3 with Subcohorts 1a, 2a and 3a negative for HAVH and 1b, 2b, 3b positive for HAVH). Part B includes only subjects negative for HAVH, with ascending doses given to Cohorts 4 to 6. Cohort 7 receives the same dose as Cohort 6, but whereas the other Cohorts are single-blinded, Cohort 7 is open-label and additionally receives a bronchoalveolar lavage (BAL). The study consists of a Screening Visit (up to 56 days before Day 1, the day of the drug administration), Visits on Day -1, 1, 2, 3, 5, 7, 14, 28 and Follow-Up Visits on Day 57 and 85. This form contains general information on any Liver Event happening during the study, including whether and when a pharmacokinetic sample has been obtained as well as information on the subject's general and liver-related medical conditions and alcohol intake. There are seperate forms for Imaging and Biopsy in case of a Liver Event.
Link
https://clinicaltrials.gov/ct2/show/NCT01476046
Stichworte
Versionen (1)
- 26.10.19 26.10.19 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
26. Oktober 2019
DOI
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Lizenz
Creative Commons BY-NC 3.0
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Phase I Trial of Intravenous TNFR1 Antagonist GSK1995057 in Healthy Subjects - NCT01476046
Liver Events incl. Pharmacokinetics, Medical Conditions, Alcohol
- StudyEvent: ODM
Beschreibung
Liver Event Seriousness
Alias
- UMLS CUI-1
- C1710056
- UMLS CUI-2
- C0023884
Beschreibung
Notification Sent
Alias
- UMLS CUI-1
- C0422202
- UMLS CUI-2
- C0023884
Beschreibung
[read-only]
Datentyp
partialDatetime
Alias
- UMLS CUI [1,1]
- C1264639
- UMLS CUI [1,2]
- C0013849
- UMLS CUI [1,3]
- C1517741
- UMLS CUI [1,4]
- C1708968
Beschreibung
[read-only]
Datentyp
partialDatetime
Alias
- UMLS CUI [1,1]
- C1264639
- UMLS CUI [1,2]
- C0205435
- UMLS CUI [1,3]
- C0013849
- UMLS CUI [1,4]
- C1708968
Beschreibung
[read-only]
Datentyp
partialDatetime
Alias
- UMLS CUI [1,1]
- C1264639
- UMLS CUI [1,2]
- C0013849
- UMLS CUI [1,3]
- C1517741
- UMLS CUI [1,4]
- C3899555
Beschreibung
[read-only]
Datentyp
partialDatetime
Alias
- UMLS CUI [1,1]
- C1264639
- UMLS CUI [1,2]
- C0013849
- UMLS CUI [1,3]
- C0205435
- UMLS CUI [1,4]
- C3899555
Beschreibung
[read-only]
Datentyp
partialDatetime
Alias
- UMLS CUI [1,1]
- C1264639
- UMLS CUI [1,2]
- C1710056
- UMLS CUI [1,3]
- C0023884
- UMLS CUI [1,4]
- C0443172
- UMLS CUI [1,5]
- C1518404
Beschreibung
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping/interruption criteria?
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0008000
- UMLS CUI-3
- C0304229
- UMLS CUI-4
- C2746065
- UMLS CUI-5
- C0243161
Beschreibung
It is particularly important to record any significant hypotension immediately prior to or concomitant with ALT elevation.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0201836
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0243161
Beschreibung
AST reached stopping criteria
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0201899
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0243161
Beschreibung
Total bilirubin reached stopping criteria
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0201913
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0243161
Beschreibung
Alkaline phosphatase reached stopping criteria
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0201850
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0243161
Beschreibung
This item is conditional. Interruption may be removed if stopping/monitoring study only.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0202148
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0243161
Beschreibung
This item is conditional. Interruption may be removed if stopping/monitoring study only.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0202035
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0243161
Beschreibung
Other liver chemistry result reached stopping criteria
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0023884
- UMLS CUI [1,3]
- C0008000
- UMLS CUI [1,4]
- C0304229
- UMLS CUI [1,5]
- C2746065
- UMLS CUI [1,6]
- C0243161
Beschreibung
Liver Events - Clinical
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
- UMLS CUI-3
- C0205210
Beschreibung
Age
Datentyp
text
Alias
- UMLS CUI [1]
- C0001779
Beschreibung
If yes, ensure Pregnancy Notification Form has been completed.
Datentyp
text
Alias
- UMLS CUI [1]
- C0032961
Beschreibung
If Yes, answer whether the results were normal
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0011923
- UMLS CUI [1,2]
- C1711359
- UMLS CUI [2,1]
- C0011923
- UMLS CUI [2,2]
- C0023884
- UMLS CUI [3]
- C0412534
- UMLS CUI [4]
- C0412620
- UMLS CUI [5]
- C0412693
- UMLS CUI [6]
- C0008310
Beschreibung
If applicable If No, record the details on the Imaging form. Please ensure the overall diagnosis indicated by imaging is captured on the Non-serious Adverse Event form or Serious Adverse Event form.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0011923
- UMLS CUI [1,2]
- C1711359
- UMLS CUI [1,3]
- C0456984
- UMLS CUI [2,1]
- C0011923
- UMLS CUI [2,2]
- C0456984
- UMLS CUI [2,3]
- C0023884
Beschreibung
If yes, complete Liver Biopsy form.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0193388
- UMLS CUI [1,2]
- C1272695
Beschreibung
If yes, record on the appropriate Concomitant Medication form.
Datentyp
text
Alias
- UMLS CUI [1]
- C2347852
- UMLS CUI [2]
- C0025125
- UMLS CUI [3]
- C0242295
- UMLS CUI [4]
- C0086190
Beschreibung
Recent fasting or significant dietary change
Datentyp
text
Alias
- UMLS CUI [1,1]
- C3671772
- UMLS CUI [1,2]
- C0332185
- UMLS CUI [2,1]
- C0332185
- UMLS CUI [2,2]
- C0015663
Beschreibung
[hidden] Item will be calculated by InForm.
Datentyp
text
Alias
- UMLS CUI [1]
- C2826267
Beschreibung
Investigational Product (Liver)
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0023884
Beschreibung
If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period. If the liver event occurred after treatment period record start and stop date of investigational product for the most recent period prior to the liver event.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0023884
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C2745955
- UMLS CUI [1,4]
- C0439564
- UMLS CUI [1,5]
- C2347804
Beschreibung
If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period. If the liver event occurred after treatment period record start and stop date of investigational product for the most recent period prior to the liver event.
Datentyp
partialDate
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0808070
Beschreibung
If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period. If the liver event occurred after treatment period record start and stop date of investigational product for the most recent period prior to the liver event.
Datentyp
partialDate
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0806020
Beschreibung
Pharmacokinetics (Liver PK)
Alias
- UMLS CUI-1
- C0005834
- UMLS CUI-2
- C0031328
- UMLS CUI-3
- C0023884
Beschreibung
An unscheduled PK sample must be obtained within obtained within 7 days of last dose. If yes, record date and time sample taken and date and time of last investigational product dose prior to PK sample
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0031328
Beschreibung
if applicable
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0031328
- UMLS CUI [1,3]
- C1264639
Beschreibung
if applicable
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C0945778
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0332152
- UMLS CUI [1,4]
- C0005834
- UMLS CUI [1,5]
- C0031328
Beschreibung
Liver disease medical conditions
Alias
- UMLS CUI-1
- C0023895
Beschreibung
Acute type A viral hepatitis
Datentyp
integer
Alias
- UMLS CUI [1]
- C0276434
Beschreibung
Hepatitis B, Chronic
Datentyp
integer
Alias
- UMLS CUI [1]
- C0524909
Beschreibung
Hepatitis C, Chronic
Datentyp
integer
Alias
- UMLS CUI [1]
- C0524910
Beschreibung
Cytomegalovirus Hepatitis
Datentyp
integer
Alias
- UMLS CUI [1]
- C0276252
Beschreibung
Infectious Mononucleosis
Datentyp
integer
Alias
- UMLS CUI [1]
- C0021345
Beschreibung
Herpes Simplex Hepatitis
Datentyp
integer
Alias
- UMLS CUI [1]
- C1963747
Beschreibung
Alcoholic Liver Diseases
Datentyp
integer
Alias
- UMLS CUI [1]
- C0023896
Beschreibung
Non-alcoholic Steatohepatitis
Datentyp
integer
Alias
- UMLS CUI [1]
- C3241937
Beschreibung
Fatty Liver
Datentyp
integer
Alias
- UMLS CUI [1]
- C0015695
Beschreibung
Hepatic Cirrhosis
Datentyp
integer
Alias
- UMLS CUI [1]
- C0023890
Beschreibung
Hemochromatosis
Datentyp
integer
Alias
- UMLS CUI [1]
- C0018995
Beschreibung
Autoimmune Hepatitis
Datentyp
integer
Alias
- UMLS CUI [1]
- C0241910
Beschreibung
It is particularly important to record any gallbladder or biliary disease, or pancreatitis, that occurred during the study.
Datentyp
integer
Alias
- UMLS CUI [1]
- C0016977
Beschreibung
Drug related liver disease conditions
Alias
- UMLS CUI-1
- C0023895
- UMLS CUI-2
- C0041755
Beschreibung
Other Liver Disease
Alias
- UMLS CUI-1
- C0023895
- UMLS CUI-2
- C0205394
Beschreibung
[hidden]
Datentyp
text
Alias
- UMLS CUI [1]
- C2348184
Beschreibung
Other liver disease
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0205394
Beschreibung
[hidden]
Datentyp
text
Alias
- UMLS CUI [1]
- C2826302
Beschreibung
[hidden]
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1140263
- UMLS CUI [1,2]
- C0871468
Beschreibung
[hidden]
Datentyp
text
Alias
- UMLS CUI [1]
- C3898442
Beschreibung
[hidden]
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Beschreibung
Other Liver Disease Conditions - Status
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0449438
Beschreibung
Other medical conditions
Alias
- UMLS CUI-1
- C0012634
- UMLS CUI-2
- C0205394
Beschreibung
Drug Allergies
Datentyp
integer
Alias
- UMLS CUI [1]
- C0013182
Beschreibung
Rheumatoid Arthritis
Datentyp
integer
Alias
- UMLS CUI [1]
- C0003873
Beschreibung
Psoriasis
Datentyp
integer
Alias
- UMLS CUI [1]
- C0033860
Beschreibung
Thyroid Disease
Datentyp
integer
Alias
- UMLS CUI [1]
- C0040128
Beschreibung
Inflammatory Bowel Disease
Datentyp
integer
Alias
- UMLS CUI [1]
- C0021390
Beschreibung
Lupus
Datentyp
integer
Alias
- UMLS CUI [1]
- C0409974
Beschreibung
Sjogren's Syndrome
Datentyp
integer
Alias
- UMLS CUI [1]
- C1527336
Beschreibung
Vitiligo
Datentyp
integer
Alias
- UMLS CUI [1]
- C0042900
Beschreibung
Alcohol Intake at Onset of Liver Event
Alias
- UMLS CUI-1
- C0001948
- UMLS CUI-2
- C0023884
- UMLS CUI-3
- C0332162
- UMLS CUI-4
- C0877248
Beschreibung
If Yes, record the average number of units of alcohol consumed per week
Datentyp
text
Alias
- UMLS CUI [1]
- C0001948
Beschreibung
if applicable
Datentyp
float
Alias
- UMLS CUI [1,1]
- C0001948
- UMLS CUI [1,2]
- C0560579
- UMLS CUI [1,3]
- C1510992
Beschreibung
[hidden] This item will be calculated by InForm.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0038586
- UMLS CUI [1,2]
- C0332307
Ähnliche Modelle
Liver Events incl. Pharmacokinetics, Medical Conditions, Alcohol
- StudyEvent: ODM
C1264639 (UMLS CUI [1,2])
C0023884 (UMLS CUI-2)
C0877248 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C0013849 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1708968 (UMLS CUI [1,4])
C0205435 (UMLS CUI [1,2])
C0013849 (UMLS CUI [1,3])
C1708968 (UMLS CUI [1,4])
C0013849 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C3899555 (UMLS CUI [1,4])
C0013849 (UMLS CUI [1,2])
C0205435 (UMLS CUI [1,3])
C3899555 (UMLS CUI [1,4])
C1710056 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])
C0443172 (UMLS CUI [1,4])
C1518404 (UMLS CUI [1,5])
C0008000 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
C2746065 (UMLS CUI-4)
C0243161 (UMLS CUI-5)
C0304229 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])
C0023884 (UMLS CUI [1,2])
C0008000 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C2746065 (UMLS CUI [1,5])
C0243161 (UMLS CUI [1,6])
C0877248 (UMLS CUI-2)
C0205210 (UMLS CUI-3)
C1711359 (UMLS CUI [1,2])
C0011923 (UMLS CUI [2,1])
C0023884 (UMLS CUI [2,2])
C0412534 (UMLS CUI [3])
C0412620 (UMLS CUI [4])
C0412693 (UMLS CUI [5])
C0008310 (UMLS CUI [6])
C1711359 (UMLS CUI [1,2])
C0456984 (UMLS CUI [1,3])
C0011923 (UMLS CUI [2,1])
C0456984 (UMLS CUI [2,2])
C0023884 (UMLS CUI [2,3])
C1272695 (UMLS CUI [1,2])
C0025125 (UMLS CUI [2])
C0242295 (UMLS CUI [3])
C0086190 (UMLS CUI [4])
C0332185 (UMLS CUI [1,2])
C0332185 (UMLS CUI [2,1])
C0015663 (UMLS CUI [2,2])
C0023884 (UMLS CUI-2)
C0877248 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
C0439564 (UMLS CUI [1,4])
C2347804 (UMLS CUI [1,5])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0031328 (UMLS CUI-2)
C0023884 (UMLS CUI-3)
C0031328 (UMLS CUI [1,2])
C0031328 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0005834 (UMLS CUI [1,4])
C0031328 (UMLS CUI [1,5])
C0041755 (UMLS CUI-2)
C0041755 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0871468 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
C0205394 (UMLS CUI-2)
C0023884 (UMLS CUI-2)
C0332162 (UMLS CUI-3)
C0877248 (UMLS CUI-4)
C0560579 (UMLS CUI [1,2])
C1510992 (UMLS CUI [1,3])
C0332307 (UMLS CUI [1,2])