The comparative study of the efficacy and safety of Simeprevir sodium at investigational stage and after marketing authorization

The comparative study of the efficacy and safety of Simeprevir sodium at investigational stage and after marketing authorization - The comparative study of the efficacy and safety of Simeprevir sodium at investigational stage and after marketing authorization

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000045086

Enrollment

Registered

2021-08-06

Start date

2021-08-10

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

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subjects who were administered simeprevir sodium from December 2013 to September 2014 in Shimane Prefecture, Japan

Exclusion criteria

Exclusion criteria: Subjects who declined use of their medical records for the study

Design outcomes

Primary

Measure	Time frame
1. The proportion of subjects who meet the inclusion/exclusion criteria of clinical trials 2. The proportion of unavailable data on the case report form 3. Differences in baseline demographic characteristics 4. The proportion of subjects who achieved Sustained Virological Response (SVR) for 12 weeks and for 24 weeks 5. The proportion of subjects who completed 24-week treatment regimen 6. Frequency of ordering laboratory tests and other to monitor the subjects 7. Frequency and severity of adverse drug events 8. Exploratory sub-group analyses of efficacy and safety of the drug	—

Measure

Time frame

1. The proportion of subjects who meet the inclusion/exclusion criteria of clinical trials 2. The proportion of unavailable data on the case report form 3. Differences in baseline demographic characteristics 4. The proportion of subjects who achieved Sustained Virological Response (SVR) for 12 weeks and for 24 weeks 5. The proportion of subjects who completed 24-week treatment regimen 6. Frequency of ordering laboratory tests and other to monitor the subjects 7. Frequency and severity of adverse drug events 8. Exploratory sub-group analyses of efficacy and safety of the drug

—

Countries

Japan

Contacts

Public ContactMami Seki

Shimane University Faculty of Medicine, Department of Medical Informatics

sekim@med.shimane-u.ac.jp0853-20-2171

Outcome results