Hepatitis C
Conditions
Keywords
Hepatitis C, PI treatment failure
Brief summary
This study is to evaluate the overall efficacy, and safety profile of the triple combination therapy of alisporivir (ALV; DEB025) plus peginterferon alfa-2a (PEG) and ribavirin (RBV) patients with chronic hepatitis C (HCV) genotype 1 who failed prior treatment with a protease inhibitor (PI).
Interventions
DRUGAlisporivir
ALV 200 mg soft gel capsules administered orally
DRUGPeginterferon alfa-2a
PEG 180 μg administered via subcutaneous (s.c.) injection once weekly
DRUGRibavirin
RBV 200 mg tablets (weight-based dose: \< 75 mg = 1000 mg/day; ≥ 75 kg = 1200 mg/day) administered orally in a divided daily dose
Sponsors
Debiopharm International SA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with chronic HCV genotype 1 infection with previous PI treatment failure 2. Three months minimum time from the last dose of previous PI treatment to the first dose of study medication
Exclusion criteria
1. Use of other investigational drugs at the time of enrollment 2. History of hypersensitivity to PEG or RBV 3. Any null non-responders to prior PEG/RBV treatment Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved Sustained Viral Response (SVR) 12 Weeks After End of Treatment (SVR12) | 12 weeks posttreatment | SVR12 was defined as hepatitis C (HCV) ribonucleic acid (RNA) laboratory value below level of quantification (LOQ) (i.e., 25 IU/ml) 12 weeks after the end of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved SVR 24 Weeks After the End of Treatment (SVR24) | 24 weeks posttreatment | SVR24 was defined as HCV RNA laboratory value \< LOQ 24 weeks after the end of treatment. |
| Percentage of Participants With HCV RNA Laboratory Value Below Level of Detection 12 Weeks After the End of Treatment (SVR12-LOD) | 12 weeks posttreatment | Level of detection (LOD) was defined as 10 IU/mL |
| Percentage of Participants Who Discontinued Study Drug or Required Dose Reduction or Dose Interruption Due to Treatment-emergent Adverse Events | 48 weeks | — |
Countries
Canada, France, Germany, Italy, Puerto Rico, Spain, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Alisporivir ALV 400 mg BID with PEG and RBV for 48 weeks. | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | Alisporivir |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 5 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
Primary
Percentage of Participants Who Achieved Sustained Viral Response (SVR) 12 Weeks After End of Treatment (SVR12)
SVR12 was defined as hepatitis C (HCV) ribonucleic acid (RNA) laboratory value below level of quantification (LOQ) (i.e., 25 IU/ml) 12 weeks after the end of treatment.
Time frame: 12 weeks posttreatment
Population: The study was terminated before the outcome measure time point.
Secondary
Percentage of Participants Who Achieved SVR 24 Weeks After the End of Treatment (SVR24)
SVR24 was defined as HCV RNA laboratory value \< LOQ 24 weeks after the end of treatment.
Time frame: 24 weeks posttreatment
Population: The study was terminated before the outcome measure time point.
Secondary
Percentage of Participants Who Discontinued Study Drug or Required Dose Reduction or Dose Interruption Due to Treatment-emergent Adverse Events
Time frame: 48 weeks
Population: The study was terminated before the outcome measure time point.
Secondary
Percentage of Participants With HCV RNA Laboratory Value Below Level of Detection 12 Weeks After the End of Treatment (SVR12-LOD)
Level of detection (LOD) was defined as 10 IU/mL
Time frame: 12 weeks posttreatment
Population: The study was terminated before the outcome measure time point.