peginterferon alfa-2b and ribavirin plus Vitamin D for chronic hepatitis C : An open-label randomized controlled trial.

peginterferon alfa-2b and ribavirin plus Vitamin D for chronic hepatitis C : An open-label randomized controlled trial. - Trial D

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003721

Enrollment

Registered

2010-06-07

Start date

2010-06-01

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

Interventions

peginterferon alfa-2b and ribavirin plus vitamin D peginterferon alfa-2b and ribavirin

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: genotype 1 and high virus load

Exclusion criteria

Exclusion criteria: 1) Patients receiving shosaiko-to 2) Autoimmune hepatitis 3) History of hypersensitivity to PEG-IFN alpha-2b 4) History of hypersensitivity to biological products such as vaccine 5) Decompenstated liver cirrhosis 6) HCC, malignat tumor 7) With or with a history of severe psychosis such as severe depression, suicidal ideation or attempt, etc. 8) Pregnant or lactating women and women who may be pregnant 9) Judged by investigator not to be appropriate for inclusion in this study

Design outcomes

Primary

Measure	Time frame
virologic response at 24weeks	—

Secondary

Measure	Time frame
virologic response at 4,8,12,16,20,24,48,72weeks and sustend virologic response Safety ( moniterd clinical and laboratory evaluation)	—

Countries

Japan

Contacts

Public ContactYoshiiku Kawakami

graduate school of biomedical science, Hiroshima university Department and medicine and molecular science

082-257-5190

Outcome results

None listed

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