Prediction of efficacy to simeprevir-based triple therapy in patients with genotype 1b and high viral load

Prediction of efficacy to simeprevir-based triple therapy in patients with genotype 1b and high viral load - Prediction of efficacy to simeprevir-based triple therapy in patients with genotype 1b and high viral load

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000022491

Enrollment

100

Registered

2016-05-27

Start date

2014-01-15

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

Patients with genotype 1b hepatitis C virus and high virus load

Interventions

To evaluate virus variant and virus dynamics within 2 weeks, 5ml/time of blood sample are collected 3 times.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adult patients with genotype 1 high viral load

Exclusion criteria

Exclusion criteria: 1) pregnant women, women who may have been pregnant, lactating women, men whose partners were pregnant, or men whose partners hoped to become pregnant; 2) patients who used shosaikoto (a Kampo medicine); 3) intractable heart disease; 4) renal failure or renal dysfunction with creatinine clearance <50 mL/min; 5) patients with uncontrollable psychoneurotic disorders; 6) hemoglobin (Hb) level <11 g/dL; 7) platelet count <70,000/mm3; 8) white blood cell count <1500/mm3 (or granulocyte count <1000/mm3); and 9) hepatic failure or all types of cancer.

Design outcomes

Primary

Measure	Time frame
Sustained virological response at 24 weeks after the end of therapy	—

Countries

Japan

Contacts

Public ContactHideyuki Tamai

Wakayama Medical University Second department of internal medicine

tamahide@wakayama-med.ac.jp073-447-2300

Outcome results

None listed

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