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

JRCT ID: jRCTs051180110

Registered date:11/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: chronic hepatitis C
• Date of first enrollment: 15/09/2016
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Oral intake of Ledipasvir 90mg with sofosbuvir 400mg once a day for 12 weeks.

Outcome(s)

• Primary Outcome: Negativity of HCVRNA at 4 week, 12 week, end of treatment(EOT), and 24 week after EOT.
• Secondary Outcome: (1) any side effects and their frequency, (2) effect on growth rate

Key inclusion & exclusion criteria

• Age minimum: 12age
• Age maximum: 18age
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Tajiri Hitoshi
• Source(s) of Monetary Support: Gilead Sciences Inc