Macrophages, Portal Hypertension, and Liver Function Duri... | NCT02526641

Studies
Macrophages, Portal Hypertension, and Liver Function During AbbVie Treatment of Chronic Hepatitis C

NCT02526641

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

Nov 4, 2020Actual

Enrollment

16Actual

Phase

Not provided

Conditions

Hepatitis C

Interventions

Functional Hepatic Nitrogen Clearance (FHNC)
Galactose Elimination Capacity (GEC)
Liver vein catheterization

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2015Actual

Primary Completion Date

Mar 2019Actual

Completion Date

Nov 2020Actual

First Submitted Date

Aug 13, 2015

First Submission Date that Met QC Criteria

Aug 14, 2015

First Posted Date

Aug 18, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 3, 2020

Last Update Posted Date

Nov 4, 2020Actual

Name	Class
Aarhus University Hospital	OTHER
AbbVie	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Investigation of the effects of the new Abbvie direct acting anti-viral (DAA) treatment of chronic viral hepatitis C infection on the macrophage specific activation marker soluble CD163, portal hypertension determined by the hepatic venous pressure gradient (HVPG), and metabolic liver function determined by the galactose elimination capacity (GEC) test and the functional hepatic nitrogen clearance (FHNC).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AbbVie			Procedure: Functional Hepatic Nitrogen Clearance (FHNC) Procedure: Galactose Elimination Capacity (GEC) Procedure: Liver vein catheterization

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Functional Hepatic Nitrogen Clearance (FHNC)	Procedure		AbbVie
Galactose Elimination Capacity (GEC)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in the hepatic venous pressure gradient determined by liver vein catheterization from baseline to 12 weeks		12 weeks
Change in the hepatic venous pressure gradient determined by liver vein catheterization from baseline to 1 year		1 year

Secondary Outcomes

Measure	Description	Time Frame
Changes in the levels of the macrophage specific activation marker sCD163		Before, during and after treatment - 60 weeks
Changes in metabolic liver function determined by the galactose elimination capacity (GEC) test		After 12 weeks treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Chronic hepatitis C genotype 1 or 4 patients initiating the new AbbVie treatment (paritaprevir, ritonavir, ombitasvir og dasabuvir sammen med ribavirin)
Child-Pugh A liver cirrhosis

Exclusion Criteria:

Severe liver dysfunction - Child-Pugh klasse B-C
Life expectancy less than 6 months
planned liver transplantation or TIPS procedure within 6 months
non-compliance to treatment or study procedures
allergy to the DAA drugs used (paritaprevir, ritonavir, ombitasvir, dasabuvir, and ribavirin)
pregnancy or expected pregnancy during the study (anti-conception has to be used)
breast feeding
portal vein thrombosis
liver cancer or other malignancies
alcohol consumption

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Chronic hepatitis C patients initiating direct-acting anti-viral therapy.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Henning Grønbæk, Professor	Aarhus University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Hepatology and Gastroenterology, Aarhus University Hospital		Aarhus		8000	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D006526	Hepatitis C
D006975	Hypertension, Portal
D005355	Fibrosis

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D006525	Hepatitis, Viral, Human

Browse Leaves

Not provided

Browse Branches

Not provided