ID

38915

Beschrijving

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 This phase I trial primarily studies the safety and tolerability of ascending single intravenous doses of the selective TNFR1 antagonist GSK1995057 in healthy volunteers, and secondly explores the drug's pharmacodynamics, pharmacokinetics, concentration in lung epithelial lining fluid as well as its effect on immune system markers. The drug is hypothesized to be useful for Acute Lung Injury. 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 is to be filled in if Liver Imaging was performed as a result of an Adverse Liver Event. There are seperate forms for general information on the Adverse Liver Event and the Liver Biopsy (if performed).

Link

https://clinicaltrials.gov/ct2/show/NCT01476046

Trefwoorden

D008107

Diagnostik, bildgebende

Clinical Trial

Klinische Studie, Phase I [Dokumenttyp]

Adverse event

Rezeptoren, Tumor-Nekrose-Faktor-, Typ I

Leber

26-10-19 26-10-19 -
12-11-19 12-11-19 - Sarah Riepenhausen

Houder van rechten

GlaxoSmithKline

Geüploaded op

12 november 2019

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0

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Phase I Trial of Intravenous TNFR1 Antagonist GSK1995057 in Healthy Subjects - NCT01476046

model
Details

Liver Imaging

1 Formulieren

StudyEvent: ODM
1. Liver Imaging

Name

Type

Description | Question | Decode (Coded Value)

Datatype

Alias

Administrative Data

Item Group

Administrative Data

C1320722 (UMLS CUI-1)

Subject Number

Item

Subject Number

integer

C2348585 (UMLS CUI [1])

Liver Imaging Number

Item

Liver Imaging Number

integer

C2711860 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])

Date of liver imaging

Item

Date of hepatic or liver imaging test

date

C2711860 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])

Liver imaging - General

Item Group

Liver imaging - General

C2711860 (UMLS CUI-1)

Liver imaging method

Item

What method was used for this imaging test?

text

C2711860 (UMLS CUI [1,1])
C1275506 (UMLS CUI [1,2])

What method was used for this imaging test?

Code List

What method was used for this imaging test?

CL Item

Ultrasound - transabdominal (1)

CL Item

Ultrasound - endoscopic (2)

CL Item

Magnetic Resonance Imaging (MRI) (3)

CL Item

Computerised Tomography (CT) (4)

CL Item

Endoscopic Retrograde Cholangiopancreatography (ERCP) (5)

CL Item

Positron Emission Tomography (PET) (6)

CL Item

Positron Emission Tomography/Computerised Tomography (PET/CT) (7)

CL Item

Other (OT)

Specify other liver imaging method

Item

Specify other method used for this imaging test

text

C2711860 (UMLS CUI [1,1])
C1275506 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])

Image quality

Item

Are images technically adequate?

text

C0806487 (UMLS CUI [1])

Are images technically adequate?

Code List

Are images technically adequate?

CL Item

Optimal (1)

CL Item

Readable, but not optimal (2)

CL Item

Not readable (3)

CL Item

Other (OT)

Specify other image quality

Item

Other, specify

text

C0806487 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])

Liver size

Item

Indicate the liver size

text

C0426688 (UMLS CUI [1])

Indicate the liver size

Code List

Indicate the liver size

CL Item

Normal size (A1)

CL Item

Hypertrophy (or enlarged) (A2)

CL Item

Atrophy (or smaller than normal) (A3)

CL Item

Segmental hypertrophy (A4)

CL Item

Other (A99)

Specify other liver size

Item

Other liver size, specify

text

C0426688 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])

Liver texture

Item

Indicate the liver texture

text

C1285481 (UMLS CUI [1])

Indicate the liver texture

Code List

Indicate the liver texture

CL Item

Normal (B1)

CL Item

Heterogenous (B2)

CL Item

Suggestive of fibrosis (B3)

CL Item

Nodular or suggestive of cirrhosis (B4)

CL Item

Other (B99)

Specify other liver texture

Item

Other liver texture, specify

text

C1285481 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])

Diffuse and/or geographic fatty infiltrate of the liver

Item

Grade the diffuse and/or geographic fatty infiltrate of the liver

text

C0015695 (UMLS CUI [1,1])
C0205219 (UMLS CUI [1,2])
C0015695 (UMLS CUI [2,1])
C1517526 (UMLS CUI [2,2])

Grade the diffuse and/or geographic fatty infiltrate of the liver

Code List

Grade the diffuse and/or geographic fatty infiltrate of the liver

CL Item

Not applicable - no fatty infiltration (C1)

CL Item

Mild (<=25%) (C2)

CL Item

Moderate (>25% to <75%) (C3)

CL Item

Severe (>=75%) (C4)

CL Item

Other, specify (C99)

Specify other diffuse and/or geographic fatty infiltrate of the liver

Item

Other diffuse and/or geographic fatty infiltrate of the liver, specify

text

C0015695 (UMLS CUI [1,1])
C0205219 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0015695 (UMLS CUI [2,1])
C1517526 (UMLS CUI [2,2])
C0205394 (UMLS CUI [2,3])
C2348235 (UMLS CUI [2,4])

Ascites

Item

Ascites present

text

C0003962 (UMLS CUI [1])

Ascites present

Code List

Ascites present

CL Item

None present (D1)

CL Item

Yes - small amount (D2)

CL Item

Yes - moderate or severe amount (D3)

CL Item

Other, specify (D99)

Specify other ascites

Item

Other ascites, specify

text

C0003962 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])

Focal Hepatic Lesions

Item Group

Are Focal Hepatic Lesions characterisable?

C0577053 (UMLS CUI-1)
C0205234 (UMLS CUI-2)

Focal Hepatic Lesions

Item

Are Focal Hepatic Lesions characterisable?

text

C0577053 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])

Focal Hepatic Lesions

Code List

Are Focal Hepatic Lesions characterisable?

CL Item

Not applicable - no hepatic lesions (E0)

CL Item

Check all that apply (E)

Solid Focal Hepatic Lesion

Item

Solid

boolean

C0577053 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
C0205208 (UMLS CUI [1,3])

Cystic Focal Hepatic Lesion

Item

Cystic

boolean

C0577053 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
C0205207 (UMLS CUI [1,3])

Focal Hepatic Lesion: Hemangioma

Item

Hemangioma

boolean

C0577053 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
C0018916 (UMLS CUI [1,3])

Focal Hepatic Lesion: Focal Nodular Hyperplasia

Item

Focal Nodular Hyperplasia

boolean

C0577053 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
C0020510 (UMLS CUI [1,3])

Other Focal Hepatic Lesions

Item

Other Focal Hepatic Lesions, specify

boolean

C0577053 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])

Specify other Focal Hepatic Lesions

Item

Other Focal Hepatic Lesions, specify

text

C0577053 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])

Gallstones or gallbladder lesions

Item Group

Gallstones or gallbladder lesions?

C0008350 (UMLS CUI-1)
C0016976 (UMLS CUI-3)
C0221198 (UMLS CUI-4)

Gallstones or gallbladder lesions

Item

Gallstones or gallbladder lesions?

text

C0008350 (UMLS CUI [1])
C0016976 (UMLS CUI [2,1])
C0221198 (UMLS CUI [2,2])

Gallstones or gallbladder lesions

Code List

Gallstones or gallbladder lesions?

CL Item

None (F0)

CL Item

Check all that apply (F)

Gallstones

Item

Gallstones

boolean

C0008350 (UMLS CUI [1])

Gallbladder polyps

Item

Gallbladder polyp(s)

boolean

C0262493 (UMLS CUI [1])

Sludge

Item

Sludge

boolean

C0860209 (UMLS CUI [1])

Gallbladder wall thickening/oedema

Item

Gallbladder wall thickening/oedema

boolean

C0744257 (UMLS CUI [1])
C0734014 (UMLS CUI [2,1])
C0013604 (UMLS CUI [2,2])

Gallbladder wall gas

Item

Gallbladder wall gas

boolean

C0734014 (UMLS CUI [1,1])
C0333139 (UMLS CUI [1,2])

Cholecystitis

Item

Cholecystitis

boolean

C0008325 (UMLS CUI [1])

Gallbladder wall calcification

Item

Gallbladder wall calcification

boolean

C0734014 (UMLS CUI [1,1])
C1533591 (UMLS CUI [1,2])

Gallbladder mass

Item

Gallbladder mass

boolean

C3874422 (UMLS CUI [1])

Other gallstones or gallbladder lesion

Item

Other gallstones or gallbladder lesions, specify

boolean

C0205394 (UMLS CUI [1,1])
C0008350 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2,1])
C0016976 (UMLS CUI [2,2])
C0221198 (UMLS CUI [2,3])

Specify other gallstones or gallbladder lesions

Item

Other gallstones or gallbladder lesions, specify

text

C0205394 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C0008350 (UMLS CUI [1,3])
C0205394 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
C0016976 (UMLS CUI [2,3])
C0221198 (UMLS CUI [2,4])

Biliary ductal lesions

Item Group

Biliary ductal lesions?

C0005423 (UMLS CUI-1)
C0221198 (UMLS CUI-2)

Biliary ductal lesions

Item

Biliary ductal lesions?

text

C0005423 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])

Biliary ductal lesions

Code List

Biliary ductal lesions?

CL Item

None (G0)

CL Item

Check all that apply (G)

Intrahepatic ductal dilation (right hepatic lobe)

Item

Intrahepatic ductal dilation (focal involving the right hepatic lobe)

boolean

C0005401 (UMLS CUI [1,1])
C0700124 (UMLS CUI [1,2])
C0227481 (UMLS CUI [1,3])

Intrahepatic ductal dilation (left hepatic lobe)

Item

Intrahepatic ductal dilation (focal involving the left hepatic lobe)

boolean

C0005401 (UMLS CUI [1,1])
C0700124 (UMLS CUI [1,2])
C0227486 (UMLS CUI [1,3])

Intrahepatic ductal dilation (right and left hepatic lobes)

Item

Intrahepatic ductal dilation (involving both right and left hepatic lobes)

boolean

C0005401 (UMLS CUI [1,1])
C0700124 (UMLS CUI [1,2])
C0227486 (UMLS CUI [1,3])
C0005401 (UMLS CUI [2,1])
C0700124 (UMLS CUI [2,2])
C0227481 (UMLS CUI [2,3])

Extrahepatic ductal dilation

Item

Extrahepatic ductal dilation

boolean

C0700124 (UMLS CUI [1,1])
C0206187 (UMLS CUI [1,2])

Diffuse ductal dilation (intrahepatic and extrahepatic ducts)

Item

Diffuse ductal dilation (involving both intrahepatic and extrahepatic ducts)

boolean

C0005401 (UMLS CUI [1,1])
C0700124 (UMLS CUI [1,2])
C0700124 (UMLS CUI [2,1])
C0206187 (UMLS CUI [2,2])

Acute Cholangitis

Item

Acute Cholangitis

boolean

C0267917 (UMLS CUI [1])

Primary sclerosing cholangitis

Item

Primary sclerosing cholangitis

boolean

C0566602 (UMLS CUI [1])

Choledocholithiasis

Item

Choledocholithiasis (gallstone in duct)

boolean

C0701818 (UMLS CUI [1])

Ductal filling defect other than gallstone

Item

Ductal filling defect(s), other than gallstone

boolean

C1512083 (UMLS CUI [1,1])
C0332555 (UMLS CUI [1,2])
C1705847 (UMLS CUI [1,3])
C0242216 (UMLS CUI [1,4])

Ductal wall thickening or oedema

Item

Ductal wall thickening or oedema

boolean

C0005423 (UMLS CUI [1,1])
C0442069 (UMLS CUI [1,2])
C0205400 (UMLS CUI [1,3])
C0005423 (UMLS CUI [2,1])
C0442069 (UMLS CUI [2,2])
C0013604 (UMLS CUI [2,3])

Choledochal cyst

Item

Choledochal cyst

boolean

C0008340 (UMLS CUI [1])

Ductal mass

Item

Ductal mass

boolean

C0005423 (UMLS CUI [1,1])
C0577559 (UMLS CUI [1,2])

Extrinsic mass compressing bile duct

Item

Extrinsic mass compressing bile duct(s)

boolean

C0205101 (UMLS CUI [1,1])
C0577559 (UMLS CUI [1,2])
C0332260 (UMLS CUI [1,3])
C0005400 (UMLS CUI [1,4])

Other Biliary ductal lesions

Item

Other Biliary ductal lesions, specify

boolean

C0005423 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])

Specify other biliary ductal lesions

Item

Other biliary ductal lesions, specify

text

C0005423 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])

Portal/Hepatic vein abnormalities

Item Group

Portal/Hepatic vein abnormalities?

C0019155 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
C0032718 (UMLS CUI-3)

Portal/Hepatic vein abnormalities

Item

Portal/Hepatic vein abnormalities?

text

C0019155 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0032718 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])

Portal/Hepatic vein abnormalities

Code List

Portal/Hepatic vein abnormalities?

CL Item

None (H0)

CL Item

Check all that apply (H)

Portal vein enlargement

Item

Portal vein enlargement

boolean

C0032718 (UMLS CUI [1,1])
C0700124 (UMLS CUI [1,2])

Hepatic vein enlargement

Item

Hepatic vein enlargement

boolean

C0019155 (UMLS CUI [1,1])
C0700124 (UMLS CUI [1,2])

Nonocclusive portal vein thrombosis

Item

Nonocclusive portal vein thrombosis

boolean

C0155773 (UMLS CUI [1,1])
C0333204 (UMLS CUI [1,2])

Occlusive portal vein thrombosis - bland

Item

Occlusive portal vein thrombosis - bland

boolean

C0155773 (UMLS CUI [1,1])
C1265798 (UMLS CUI [1,2])

Hepatic vein thrombosis - bland

Item

Hepatic vein thrombosis - bland

boolean

C0019154 (UMLS CUI [1,1])
C1265798 (UMLS CUI [1,2])

Occlusive portal vein thrombosis - malignant

Item

Occlusive portal vein thrombosis - malignant

boolean

C0155773 (UMLS CUI [1,1])
C0205282 (UMLS CUI [1,2])

Hepatic vein thrombosis - malignant

Item

Hepatic vein thrombosis - malignant

boolean

C0019154 (UMLS CUI [1,1])
C0205282 (UMLS CUI [1,2])

Involvement of the main portal vein

Item

Involvement of the main portal vein

boolean

C0392760 (UMLS CUI [1,1])
C1183135 (UMLS CUI [1,2])

Involvement of the right portal vein

Item

Involvement of the right portal vein

boolean

C0392760 (UMLS CUI [1,1])
C0205090 (UMLS CUI [1,2])
C0032718 (UMLS CUI [1,3])

Involvement of the left portal vein

Item

Involvement of the left portal vein

boolean

C0392760 (UMLS CUI [1,1])
C0205091 (UMLS CUI [1,2])
C0032718 (UMLS CUI [1,3])

Budd-Chiari syndrome

Item

Budd-Chiari syndrome

boolean

C0856761 (UMLS CUI [1])

Other portal/hepatic vein abnormalities

Item

Other portal/hepatic vein abnormalities, specify

boolean

C0205394 (UMLS CUI [1,1])
C0019155 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C0205394 (UMLS CUI [2,1])
C0032718 (UMLS CUI [2,2])
C1704258 (UMLS CUI [2,3])

Specify other portal/hepatic vein abnormalities

Item

Other portal/hepatic vein abnormalities, specify

text

C0019155 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0032718 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
C0205394 (UMLS CUI [2,3])
C2348235 (UMLS CUI [2,4])

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Model Commentaren :

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Item Commentaren voor :

Phase I Trial of Intravenous TNFR1 Antagonist GSK1995057 in Healthy Subjects - NCT01476046

Liver Imaging

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