NCT01935817

Brief Summary

Chronic hepatitis C is both a virologic and a fibrotic disease, with mortality resulting mainly from the complications of cirrhosis and HCC. The investigators' aim will be to evaluate the impact on of supplementation with a new pharmaceutical complex of silybin-vitamin E-phospholipids in patients with chronic hepatitis C treated with Pegylated-Interferon-α2b plus Ribavirin.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 5, 2013

Completed
Last Updated

September 5, 2013

Status Verified

September 1, 2013

Enrollment Period

2.5 years

First QC Date

September 1, 2013

Last Update Submit

September 4, 2013

Conditions

Liver Fibrosis

Outcome Measures

Primary Outcomes (1)

  • transforming growth factor beta

    serum marker of liver fibrosis

    12 months

Secondary Outcomes (1)

  • hyaluronic acid

    12 months

Other Outcomes (3)

  • metalloproteinase 2

    12 months

  • amino-terminal pro-peptide of type III procollagen

    12 months

  • tissue inhibitor of matrix metalloproteinase type I

    12 months

Study Arms (2)

Silybin + vitamin E + phospholipids complex

ACTIVE COMPARATOR

Silybin 94 mg + vitamin E 90 mg + phospholipids 194 mg in one pill per day for 12 months

Drug: Silybin 94 mg + vitamin E 90 mg + phospholipids 194 mg complex

sugar pill

PLACEBO COMPARATOR

one placebo pill per day for 12 months

Drug: Placebo

Interventions

Silybin 94 mg + vitamin E 90 mg + phospholipids 194 mg complexDRUG
Silybin + vitamin E + phospholipids complex
PlaceboDRUG
sugar pill

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older,
  • infection by HCV
  • under treatment with pegylated interferon 2 alpha and ribavirin

You may not qualify if:

  • other liver diseases
  • cancer
  • severe jaundice
  • pulmonary and renal chronic diseases
  • prostatic diseases
  • autoimmune diseases
  • diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cannizzaro Hospital

Catania, Sicily, 95125, Italy

Location

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

SilybinVitamin EPhospholipids

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SilymarinFlavonolignansFlavonoidsChromonesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingMembrane LipidsLipids

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
A.P.

Study Record Dates

First Submitted

September 1, 2013

First Posted

September 5, 2013

Study Start

June 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

September 5, 2013

Record last verified: 2013-09

Locations

IT(1)