Hepatitis C
Conditions
Keywords
Chronic Hepatitis C, Protease Inhibitor
Brief summary
The purpose of this study is to assess the efficacy and safety after administration of MP-424 to patients with chronic hepatitis C.
Interventions
Three tablets of MP-424 250mg tablet at a time, every 8 hours, 24 weeks administration (dose in a day: 2250 mg)
Sponsors
Vertex Pharmaceuticals Incorporated
Tanabe Pharma Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients diagnosed with genotype 1b chronic hepatitis C * Patients naive to the concomitant medications with interferon
Exclusion criteria
* Patients diagnosed with decompensated cirrhosis * Patients diagnosed with positive HBs antigen in the test
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Undetectable HCV RNA at 24 Weeks After Completion of Drug Administration | 24 Weeks After Completion of Drug Administration (dosing period is 24 Weeks) or drug withdrawal. The subjects were assessed at 24 weeks following the last dose of study drug. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MP-424 Drug: MP-424 750 mg every 8 hours for 24 weeks Other Name: Telaprevir | 15 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | Physician Decision | 7 |
| Overall Study | Stopping Criteria | 3 |
| Overall Study | Unmatch Criteria | 1 |
Baseline characteristics
| Characteristic | MP-424 |
|---|---|
| Age, Continuous | 56.9 years STANDARD_DEVIATION 6.7 |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 14 / 15 |
| serious Total, serious adverse events | 1 / 15 |
Outcome results
Primary
Undetectable HCV RNA at 24 Weeks After Completion of Drug Administration
Time frame: 24 Weeks After Completion of Drug Administration (dosing period is 24 Weeks) or drug withdrawal. The subjects were assessed at 24 weeks following the last dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MP-424 | Undetectable HCV RNA at 24 Weeks After Completion of Drug Administration | 1 participants |