Randomized controlled trial of 72-week Peg-IFN alpha-2b/ribavirin therapy with or without EPL (polyenephosphatidylcholine) for chronic hepatitis C patients with genotype 1b and high viral load

Randomized controlled trial of 72-week Peg-IFN alpha-2b/ribavirin therapy with or without EPL (polyenephosphatidylcholine) for chronic hepatitis C patients with genotype 1b and high viral load - GLSG,2007,PEG-Riba

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000000646

Enrollment

200

Registered

2014-03-01

Start date

2007-03-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Chronic hepatitis C with serotype 1 and high viral load

Interventions

The group of Peg-IFN alpha/rivavirin with EPL therapy The group of Peg-IFN alpha/rivavirin without EPL therapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. The cases of HCV-RNA-positive with serogroup 1 and high viral load 2. The cases without regard to the history of IFN therapy 3. The cases diagnosed as chronic hepatitis by liver biopsy within 12 months

Exclusion criteria

Exclusion criteria: 1.The complication of the other liver diseases 2.Liver cirrhosis 3.Prick test-positive 4.IFN,rivavirin or EPL sensitivity 5.During pregnancy, the possibility of pregnancy or during lactation 6.Depression 7.The possibility of autoimmune diseases 8.Uncontrolled diabetes 9.Uncontrolled hypertension 10.While taking Sho-saiko-to 11.Febrile condition 12.Hematopenia 13.Poor function of bone marrow, kidney, heart or lung

Design outcomes

Primary

Measure	Time frame
1.The improvement of sustained viral response 2.The frequency of dose reduction of ribavirin due to anemia	—

Countries

Japan

Contacts

Public ContactKen Sato

Gunma University Graduate School of Medicine Department of Medicine and Molecular Science

satoken@showa.gunma-u.ac.jp027-220-8127

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026