NCT01018615 is a Phase 1 clinical trial of silymarin in Chronic Hepatitis C, sponsored by University of North Carolina, Chapel Hill.

Who is sponsoring NCT01018615?

NCT01018615 is sponsored by University of North Carolina, Chapel Hill.

What drugs are being tested in NCT01018615?

Interventions in NCT01018615: silymarin, green tea extract (EGCG).

What condition does NCT01018615 study?

NCT01018615 studies Chronic Hepatitis C, Oxidative Stress.

Is NCT01018615 still recruiting?

NCT01018615 is currently completed. Last updated 15 April 2017.

Last reviewed 2017-04-15 · How we verify

NCT01018615

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Steady-State Pharmacokinetic Interactions of Green Tea Catechins and Silymarin Flavonolignans in Treatment Naïve Patients With Chronic Hepatitis C Infection

Completed Phase 1 Last updated 15 April 2017

What this trial tests

Phase 1 trial testing silymarin in Chronic Hepatitis C in 28 participants. Completed in 1 July 2013.

Timeline

1 November 2009

Primary endpoint
1 April 2013

1 July 2013

Quick facts

Lead sponsor	University of North Carolina, Chapel Hill
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	28
Start date	1 November 2009
Primary completion	1 April 2013
Estimated completion	1 July 2013
Sites	1 location across United States

Drugs / interventions tested

silymarin — full drug profile →
green tea extract (EGCG)

Conditions studied

Chronic Hepatitis C — all drugs for Chronic Hepatitis C →
Oxidative Stress — all drugs for Oxidative Stress →

Sponsor

University of North Carolina, Chapel Hill

Who can join

18 and older, any sex, with Chronic Hepatitis C or Oxidative Stress. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

To assess the safety and tolerability of coadministered silymarin and green tea extract at different doses in patients with chronic hepatitis C.
Time frame: November 2009 to September 2012

Sponsor's own description

The purpose of this study is to determine if the safety, metabolism, and antioxidant activity of silymarin and green tea extract are changed when they are given in combination to patients with chronic hepatitis C infection.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

The Potential and Action Mechanism of Polyphenols in the Treatment of Liver Diseases.
Li S, Tan HY, Wang N, Cheung F, et al · · 2018 · cited 98× · PMID 29507653 · DOI 10.1155/2018/8394818
Hepatoprotective and antiviral functions of silymarin components in hepatitis C virus infection.
Polyak SJ, Ferenci P, Pawlotsky JM. · · 2013 · cited 78× · PMID 23213025 · DOI 10.1002/hep.26179
Targeting cell entry of enveloped viruses as an antiviral strategy.
Teissier E, Penin F, Pécheur EI. · · 2010 · cited 70× · PMID 21193846 · DOI 10.3390/molecules16010221
The Immune System in Duchenne Muscular Dystrophy Pathogenesis.
Tripodi L, Villa C, Molinaro D, Torrente Y, et al · · 2021 · cited 37× · PMID 34680564 · DOI 10.3390/biomedicines9101447

Verify or expand the search:

Other recruiting trials for Chronic Hepatitis C

Currently open trials in the same condition.

NCT06180590 — The Efficacy of Vosevi in Treating DAA-experienced Patients · recruiting
NCT03993925 — Enhancing Access to Care for Chronic Hepatitis C Infected Populations in Hong Kong · active not recruiting

Other University of North Carolina, Chapel Hill trials

Trials by the same sponsor.

NCT06841913 — Woodsmoke Exposure, Influenza Infection, and Nasal Immunity · Phase 4 · suspended
NCT07383428 — The INICIO-Guatemala Study · NA · not yet recruiting
NCT07528443 — Ultraprocessed Foods in Colombia · NA · not yet recruiting
NCT07507370 — CARED : A Novel Rapid Treatment Paradigm for Depression · NA · not yet recruiting
NCT07534254 — Piloting a Generative Artificial Intelligence Chatbot in a Mobile Weight Loss Program · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01018615 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of North Carolina, Chapel Hill
Last refreshed: 15 April 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01018615.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing