on-randomized clinical trial of the efficacy of Ledipasvir and Sofosbuvir in children with genotype 1 hepatitis C virus infectio

Phase 2

• Conditions: chronic hepatitis C; B182

• Registration Number: JPRN-jRCTs051180110
• Lead Sponsor: Tajiri Hitoshi

Brief Summary

Combination therapy of ledipasvir and sofosbuvir was safe and effective in the two cases.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-11
• Study Completion: 2020-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

1. Patients who are visiting the department of Pediatrics or being admitted in our institute.
2. Patients with age 12 and 18 years at the agreement acquisition.
3. HCV genotype-1 infection.
4. Written informed consent after adequate explanation and acceptance.

Exclusion Criteria

1. Patients with a suspicion of cirrhosis by blood examination or imaging studies.
2. Patients who is diagnosed as liver cirrhosis by pathological examination.
3. Patients with hepatocellular carcinoma.
4. Patients with poor adherence of medicine.
5. Patients who have any underlying disorders which can be affected by the treatment.
6. Patients who are assessed to be ineligible for this study by the principle investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified