The beneficial effect and safety Eldecalcitol with combined peginterferon alpha-2a plus ribavirin for chronic hepatitis C patients with osteoporosis

The beneficial effect and safety Eldecalcitol with combined peginterferon alpha-2a plus ribavirin for chronic hepatitis C patients with osteoporosis - CHALLENGE A plus trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007070

Enrollment

Registered

2015-03-31

Start date

2011-09-01

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 osteoporosis

Interventions

Peginterferon alpha 2a Ribavirin Eldecalcitol

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The following chronic hepatitis C patients with Genotype 1 and high viral lord were eligible to enter the trial 1. Osteoporosis 2. HCV-RNA>=5.0 LogIU/mL 3. WBC counts>=3,000/microL 4. Neutrophil counts>=1,500/microL 5. Hemoglobin concentration>=12g/dL 6. Platelet counts>=90,000/microL 7. the presense of liver biopsy is not asked 8. the presense of the IFN treatment history is not asked patients who provided written informed consent to participate the study prior to enrollment

Exclusion criteria

Exclusion criteria: The following patients were excluded 1. women of childbearing potential and pregnancy, lactating women 2. allergic to ribavirin or other nucleoside analoges 3. an uncontrollable heart trouble( myocardial infarction, heart failure, or arrhythmia) 4. hemoglobibopathy ( thalassemia, sickle cell disease) 5. severe renal disease or Ccr<50mL/min 6. severe depression or psychosomatic disorders 7. severe liver diseases 8. autoimmune hepatitis or HBV 9. drug allegy against interferon 10. allergic to vaccine or biological preperations 11. concomitant herbal medication of Sho-saiko-to 13. history of interstitial pneumonia 14. patients who take active vitamin D3 other than Eldecalcitol 15. other conditions considerd inappropriate by attending physician

Design outcomes

Primary

Measure	Time frame
Sustained Virological Response ( SVR )	—

Secondary

Measure	Time frame
ALT normalization Safety	—

Countries

Japan

Contacts

Public ContactAkihiro Tamori

Osaka City University, Graduate School of Medicine, Dept. of Hepatology

webmaster@med.osaka-cu.ac.jp06-6645-3435

Outcome results

None listed

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