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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-UMIN000006285
Enrollment
50
Registered
2016-12-31
Start date
2011-07-01
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

Sponsors

Department of Hepatology, Osaka City University
Lead Sponsor

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 Osteoporosis HCV-RNA>=5.0 LogIU/mL WBC counts>=3,000/microL Neutrophil counts>=1,500/microL Hemoglobin concentration>=12g/dL Platelet counts>=90,000/microL the presense of liver biopsy is not asked 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 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

Outcome results

None listed

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