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The beneficial effect and safety Eldecalcitol with combined peginterferon alpha-2a plus ribavirin for hepatitis C virus-related compensated cirrhosis with osteoporosis

The beneficial effect and safety Eldecalcitol with combined peginterferon alpha-2a plus ribavirin for hepatitis C virus-related compensated cirrhosis with osteoporosis - CHALLENGE D trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000006283
Enrollment
50
Registered
2016-12-31
Start date
2014-03-31
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

Hepatitis C virus-related compensated cirrhosis with osteoporosis

Interventions

Sponsors

Department of Hepatology, Osaka City University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The following hepatitis C virus-related compensated cirrhosis patients were eligible to enter the trial Osteoporosis patients to whom it was confirmed that there was no hepatocellular carcinoma by imaging test (CT or MRI) WBC counts>=3,000/microL Neutrophil counts>=1,500/microL Hemoglobin concentration>=12g/dL Platelet counts>=75,000/microL patients who provided written informed consent to participate the study prior to enrollment

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Sustained Virological Response ( SVR )

Secondary

MeasureTime frame
ALT normalization Safety

Countries

Japan

Contacts

Public ContactAkihiro Tamori

Osaka City University, Graduate School of Medicine Department of Hepatology

kantansuinaika@med.osaka-cu.ac.jp06-6645-3811

Outcome results

None listed

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