Hepatitis C
Conditions
Keywords
Chronic hepatitis C, Cyclophilin inhibitor
Brief summary
This study will assess the safety and efficacy of alisporivir (ALV) and boceprevir (BOC), each in combination with Peginterferon alfa-2a (PEG) and Ribavirin (RBV), in African American participants who have never received treatment for their chronic hepatitis C (HCV) genotype 1 infection.
Interventions
DRUGAlisporivir
ALV 200 mg soft gel capsules administered orally
DRUGBoceprevir
BOC 800 mg (4 x 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
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Chronic HCV genotype 1 infection * No previous treatment for HCV infection * African American ethnicity * Serum HCV RNA ≥ 1000 IU/ml, assessed by quantitative polymerase chain reaction or equivalent at screening visit, no upper limit * A liver biopsy within 3 years prior to baseline
Exclusion criteria
* HCV genotype different from genotype 1 or co-infection with other HCV genotype * Co-infection with Hepatitis B or HIV * Any other cause of relevant liver disease other than HCV * Presence or history of hepatic decompensation * Alanine aminotransferase (ALT) ≥ 10 times ULN, more than 1 episode of elevated bilirubin (\> ULN) in past 6 months Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants That Discontinued Study Drug or Required Dose Reduction or Dose Interruption Due to Treatment-emergent Adverse Events | within 48 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Emergence of Resistant Mutations | within 48 weeks | — |
| Percentage of Participants Who Achieved Sustained Virologic Response (SVR) 24 Weeks After the End of Treatment (SVR24) | 24 weeks post-treatment | SVR24 was defined as hepatitis C virus (HCV) RNA undetectable (by limit of detection) 24 weeks after end of treatment. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Enrolled Participants Analysis was performed on all enrolled participants. | 8 |
| Total | 8 |
Baseline characteristics
| Characteristic | All Enrolled Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Gender Female | 5 Participants |
| Gender Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 5 / 5 | 8 / 8 | 4 / 8 | 1 / 6 |
| serious Total, serious adverse events | 0 / 5 | 1 / 8 | 0 / 8 | 0 / 6 |
Outcome results
Primary
Percentage of Participants That Discontinued Study Drug or Required Dose Reduction or Dose Interruption Due to Treatment-emergent Adverse Events
Time frame: within 48 weeks
Population: No data has been reported because planned data analyses were not performed as the study was terminated before the outcome measure time point.
Secondary
Percentage of Participants Who Achieved Sustained Virologic Response (SVR) 24 Weeks After the End of Treatment (SVR24)
SVR24 was defined as hepatitis C virus (HCV) RNA undetectable (by limit of detection) 24 weeks after end of treatment.
Time frame: 24 weeks post-treatment
Population: No data has been reported because planned data analyses were not performed as the study was terminated before the outcome measure time point.
Secondary
Percentage of Participants With Emergence of Resistant Mutations
Time frame: within 48 weeks
Population: No data has been reported because planned data analyses were not performed as the study was terminated before the outcome measure time point.