Response-Guided Interferon Therapy for patients with chronic hepatitis C of the Genotype 1 high viral load: Japanese multi-center, randomized controlled study: (ReGIT-J study)

Phase 4

• Conditions: Chronic hepatitis C

• Registration Number: JPRN-UMIN000002748
• Lead Sponsor: Hyogo College Of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-11-11
• Study Completion: 2010-12-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

1.A pregnant woman, the woman who may have become pregnant, or the woman under breastfeeding 2.The patient who has an anamnesis of hypersensitivity to the ingredient or other nucleoside analogs of this agent (acyclovir, ganciclovir, Bidarabin, etc.) 3.A patient with cardiac disease (myocardial infarction, heart failure, abnormal heart rhythm etc.) with difficult control 4.The patient of abnormal hemoglobin diseases (sarasemia, drepanocytic anemia, etc.) 5.The patient to whom the following renal dysfunction has chronic renal failure or a creatinine clearance by 50mL/min 6.A patient with the patient in serious mental disease states, such as serious depression, suicide ideation, or a suicide attempt, or its anamnesis 7.A critical impaired liver function patient 8.The patient of autoimmune hepatitis 9.The patient who is prescribing Syousaikotou 10.The chronic liver disease patient of others, such as autoimmune hepatitis and alcoholic hepatitis 11.The patient who has an anamnesis of hypersensitivity to the ingredient or other interferon tablets of this agent 12.The patient who has an anamnesis of hypersensitivity to biological preparation, such as a vaccine 13.The patient of liver cirrhosis, hepatic insufficiency, and cancer of liver 14.The patient who meets at least one standard of the following clinical laboratory test result / before a medication start before treatment WBC countLess than 3,000/mm3 neutrophil countLess than 1,500/mm3 PLT countLess than 90,000/mm3 Hemoglobin contentLess than 12g/dl 15.In addition, the patient whom the examination doctor in attendance judged that the participation to an exam is unsuitable

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Virological response:SVR HCVRNA negativity of 24 weeks of end of treatment