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Non-randomized clinical trial of the efficacy of Sofosbuvir and Ribavirin in children with genotype 2 hepatitis C virus infection

Evaluation of the efficacy of Sofosbuvir and Ribavirin in children with genotype 2 hepatitis C virus infection

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs051180111
Enrollment
5
Registered
2019-03-11
Start date
2017-03-15
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 chronic hepatitis C

Interventions

Oral intake of Sovaldi 400mg once a day with Rebetol twice a day
600mg for those with body weight below 60kg, 800mg for those between 60 and 80kg, or 100mg for those over 80kg.

Sponsors

Tajiri Hitoshi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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-2 infection. 4. Written informed consent after adequate explanation and acceptance.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Negativity of HCVRNA at 4 week, 12 week, end of treatment(EOT), and 24 week after EOT.

Secondary

MeasureTime frame
(1) any side effects and their frequency, (2) effect on growth rate

Contacts

Public ContactHitoshi Tajiri

Osaka General Medical Center

tajiriji@gh.opho.jp+81-6-6692-1201

Outcome results

None listed

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