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

Evaluation of the efficacy of Ledipasvir and Sofosbuvir in children with genotype 1 hepatitis C virus infection

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs051180110

Enrollment

Registered

2019-03-11

Start date

2016-09-15

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 Ledipasvir 90mg with sofosbuvir 400mg once a day for 12 weeks.

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-1 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

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

Secondary

Measure	Time 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