Effects of oral and intravenous lipid load on Hepatitis C virus concentrations in serum and lipoprotein subfractions

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-002351-34-AT

Enrollment

Unknown

Registered

2012-10-10

Start date

2013-02-21

Completion date

Unknown

Last updated

2017-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic hepatitis C

Interventions

Trade Name: Intralipid 20%-Emulsion zur Infusion Product Name: Intralipid 20%-Emulsion zur Infusion Pharmaceutical Form: Emulsion for infusion INN or Proposed INN: Intralipid 20% Emulsion zu Infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 30 adult patients with chronic hepatitis C, either untreated or nonresponders who have not received antiviral therapy within the last 6 months. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patients with lipoprotein disorders Patients with portocaval shunts (spontaneous or TIPS) Patients on lipid lowering therapy Known soy bean and nuts allergy

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of the study is the quantification of serum HCV RNA and HCVVLDF after dietary and intravenous fat intake in .30 chronically infected patients with different genotypes (GT1, 3). ;Secondary Objective: ;Primary end point(s): Changes in serum HCV-RNA and HCVVLDF after oral or intravenous fat load;Timepoint(s) of evaluation of this end point: pre-dose, 60 and 180 minutes post fat intake.	—

Measure

Time frame

Main Objective: The aim of the study is the quantification of serum HCV RNA and HCVVLDF after dietary and intravenous fat intake in .30 chronically infected patients with different genotypes (GT1, 3). ;Secondary Objective: ;Primary end point(s): Changes in serum HCV-RNA and HCVVLDF after oral or intravenous fat load;Timepoint(s) of evaluation of this end point: pre-dose, 60 and 180 minutes post fat intake.

—

Secondary

Measure	Time frame
Secondary end point(s): Age, Sex, BMI, total serum HCV RNA, cholesterol level, triglyceride level, HDL, LDL, VLDL, ApoB level, Apo E level, Insulin, HOMA-IR, fibrosis stage (Metavir, fibroscan, FIB-4 score);Timepoint(s) of evaluation of this end point: pre-dose, 60 and 180 minutes post fat intake.	—

Countries

Austria

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026