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An open-label randomized controlled trial to assess the efficacy and safety of chronic hepatitis C patients with vitaminD plus peginterferon alpha-2a /ribavirin.versus alfacalcidol plus peginterferon alpha-2a /ribavirin.

An open-label randomized controlled trial to assess the efficacy and safety of chronic hepatitis C patients with vitaminD plus peginterferon alpha-2a /ribavirin.versus alfacalcidol plus peginterferon alpha-2a /ribavirin. - Vitamin D or Alfacalcidol with peginterferon alfa-2a plus ribavirin for treatment of chronic hepatitis C patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000004210
Enrollment
40
Registered
2010-09-17
Start date
2010-11-01
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 patients with genotype 1 and high viral load (&gt

Interventions

Sponsors

Saitama Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The following chronic hepatitis C patients with serogroup 1 and high viral load were eligible to enter the trial 1) From 18 years old or over 2)Chronic hepatitis C 3)The presence of the liver biopsy is not asked 4)HCV RNA>=5LogIU/mL 5)Platelet count >=90,000/micro L 6)WBC count>=3,000/micro L. Neutrophil count >=1,500/micro L. Hemoglobin concentration >=12g/dL. 7)The presence of the IFN treatment history is not asked 8)Patients who provided written informed consents to participate the study prior to enrollment

Exclusion criteria

Exclusion criteria: The following patients were excluded 1)Women of childbearing potential and pregnancy, lactating woman 2) allergic to ribavirin or nucleoside analogues 3)an uncontrollable heart trouble (myocardial infarction, heart failure, or arrhythmia) 4)hemoglobinopathy(thalassemia, sickle cell disease) 5) severe renal disease, Ccr <50ml/min 6) severe depression or psychosomatic disorders 7)severe liver disease 8) autoimmune hepatitis or HBV 9) drug allergy against interferon 10) Allergic to vaccine or biological preparations 11) Concomitant herbal medication of Sho-saikoto 12) history of interstitial pneumonia 13)Other conditions considered inappropriate by attending physician

Design outcomes

Primary

MeasureTime frame
Negative result of HCV RNA test at 24 weeks after terminating therapy

Countries

Japan

Contacts

Public ContactNobuaki Nakayama

Saitama Medical University Division of Gastroenterology and Hepatology,internal Medicine

Outcome results

None listed

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