Efficacy and safety of simeprevir/pegylated-interferon/ribavirin combination therapy with Vitamin D3 in chronic hepatitis C patients: multi-center, open label, randomized, controlled study

Efficacy and safety of simeprevir/pegylated-interferon/ribavirin combination therapy with Vitamin D3 in chronic hepatitis C patients: multi-center, open label, randomized, controlled study - Simeprevir/peg-interferon/ribavirin combination therapy with or without Vitamin D3

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000013017

Enrollment

150

Registered

2014-01-30

Start date

2013-12-09

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

Simeprevir/pegylated-interferon/ribavirin combination therapy with Vitamin D3 for 24weeks Simeprevir/pegylated-interferon/ribavirin combination therapy without Vitamin D3 for 24weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patient with HCV RNA high viral load (>5.0 log IU/mL) as determined by quantitative analysis with real-time polymerase chain reaction (PCR), infection with HCV genotype 1b, IL28B (rs8099917) minor genotype (TG or GG), white blood cell (WBC) count > 2,000/mm3, neutrophil count > 1,500/mm3, platelet count > 80,000/mm3, and hemoglobin concentration > 11.0 g/dl.

Exclusion criteria

Exclusion criteria: 1. other liver diseases, including autoimmune hepatitis, primary biliary cirrhosis, and alcoholic disease 2. positive result for hepatitis B surface antigen and antibody to human immunodeficiency virus type-1 3. decompensated liver cirrhosis 4. severe renal disorder 5. pregnant woman or lactating mother 6. allergy to IFN, ribavirin, protease inhibitor or biological preparations such as vaccines. 7. poorly controlled diabetes; poorly controlled heart failure;poorly controlled hypertension 8. medication with Chinese herbal medicine 9. medical history of interstitial pneumonia 10. severe depression 11. hyperparathyroidism 12. hypercarcemia 13. medication with other vitamin D preparations

Design outcomes

Primary

Measure	Time frame
Sustained virological response rate	—

Secondary

Measure	Time frame
Safety and HCV-RNA dynamics	—

Countries

Japan

Contacts

Public ContactMasanori Atsukawa

Nippon Medical School Chiba Hokusoh Hospital Division of Gastroenterology

atsukawa-nms@umin.ac.jp0476-99-1111

Outcome results

None listed

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