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A randomized, double-blind, placebo-controlled trial on the efficacy of 12 months of treatment with Realsil in subjects with hipertransaminasemia and steatosis or non-alcoholic steatohepatitis with or without HCV infection.

A randomized, double-blind, placebo-controlled trial on the efficacy of 12 months of treatment with Realsil in subjects with hipertransaminasemia and steatosis or non-alcoholic steatohepatitis with or without HCV infection.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-000860-24-IT
Enrollment
200
Registered
2005-08-25
Start date
2005-11-15
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

Subjects with hipertransaminasemia and steatosis or non-alcoholic steatohepatitis with or without HCV infection. MedDRA version: 6.1 Level: SOC Classification code 10019805

Interventions

Product Name: REALSIL ® Product Code: NA Pharmaceutical Form: Granules CAS Number: NA Current Sponsor code: NA Concentration unit: g gram(s) Concentration type: equal Concentration number: 6-

Sponsors

IBI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Main Objective: ;Secondary Objective: ;Primary end point(s):—

Countries

Italy

Outcome results

None listed

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