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The effect and safety in Telaprevir with combined peginterferon alpha-2b plus ribavirin for chronic hepatitis C patients

The effect and safety in Telaprevir with combined peginterferon alpha-2b plus ribavirin for chronic hepatitis C patients - Drug adjustment on adverse effect of telaprevir combined therapy (TPR-dose trial)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000007071
Enrollment
100
Registered
2015-12-31
Start date
2012-01-01
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

Interventions

Telaprevir reduction Peginterferon alpha 2b Ribavirin Telaprevir Peginterferon alpha 2b Ribavirin reduction

Sponsors

Department of Hepatology, Osaka City University , Graduate School of Medicine
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 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 Presence of liver biopsy is not asked Presence 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 analogues 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 allergy against interferon

Design outcomes

Primary

MeasureTime frame
Sustained Virological Response ( SVR ) at week 24

Secondary

MeasureTime frame
ALT normalization Safety

Countries

Japan

Contacts

Public ContactAkihiro Tamori

Osaka City University, Graduate School of Medicine Department of Hepatology

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

Outcome results

None listed

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