Chronic Hepatitis C Infection
Conditions
Brief summary
The purpose of this study was to evaluate the safety, tolerability, and efficacy of 12 weeks of treatment with ACH-0143102 and ribavirin in genotype 1b (GT1b), treatment-naive, hepatitis C virus (HCV) participants.
Detailed description
A Phase 1b, pilot study that evaluated the safety, tolerability, and antiviral activity of oral ACH-0143102 administered in combination with ribavirin for 12 weeks in treatment-naive participants with chronic HCV GT1b.
Interventions
DRUGACH-0143102
DRUGRibavirin
Sponsors
Achillion, a wholly owned subsidiary of Alexion
Alexion Pharmaceuticals, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males and females aged 18 years and older. * Clinical diagnosis of hepatitis C with GT1b. * Chronic hepatitis C treatment-naive participants. * Interleukin 28B genotype CC. * HCV ribonucleic acid \> 10,000 international units/milliliter at screening. * Female participants must be willing to use 2 effective methods of contraception during the dosing period and for 6 months after the last dose of ribavirin. * Male participants must be willing to use an effective barrier method of contraception throughout the dosing period and for 6 months after the last dose of ribavirin. Male participants must agree not to donate sperm while enrolled in the study and for 6 months after the last dose of ribavirin. * Willing to participate in all study activities and all study requirements.
Exclusion criteria
* Body mass index \> 36 kilograms/meter squared. * Pregnant or nursing females. * Clinically significant laboratory abnormalities at screening. * Previous participation in a clinical trial with protease inhibitor and/or non-structural protein 5A inhibitor. * Human immunodeficiency virus infection or other liver diseases. * Positive hepatitis B surface antigen. * Liver cirrhosis. * Uncontrolled psychiatric disease. * Clinical evidence of chronic cardiac disease. * History of malignancy of any organ system within 5 years.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sustained Virologic Response At 12 Weeks (SVR12) | 12 weeks following the last dose | To determine the incidence of the SVR12 after the completion of dosing with ACH-0143102 plus ribavirin, reported as hepatitis C virus ribonucleic acid less than the limit of quantification at that time point. |
Participant flow
Recruitment details
Participants were recruited from 6 sites in the United States between 05 September 2012 and 11 December, 2012.
Pre-assignment details
Participants were screened within 4 weeks (-28 to -1 days) before administration of the study drug. Participants who meet all eligibility criteria were instructed to arrive at the study center on the baseline day.
Participants by arm
| Arm | Count |
|---|---|
| ACH-0143102 Plus Ribavirin ACH-0143102 (225 mg) loading dose on Day 1, followed by maintenance doses (75 mg) on Days 2-84, plus weight-based ribavirin as per label on Days 1-84. | 8 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 2 |
Baseline characteristics
| Characteristic | ACH-0143102 Plus Ribavirin |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Age, Continuous | 50.07 years STANDARD_DEVIATION 11.34 |
| Body Mass Index | 28.13 kilograms/meter squared STANDARD_DEVIATION 4.183 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Sex: Female, Male Female | 2 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 | 6 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
Primary
Sustained Virologic Response At 12 Weeks (SVR12)
To determine the incidence of the SVR12 after the completion of dosing with ACH-0143102 plus ribavirin, reported as hepatitis C virus ribonucleic acid less than the limit of quantification at that time point.
Time frame: 12 weeks following the last dose
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ACH-0143102 Plus Ribavirin | Sustained Virologic Response At 12 Weeks (SVR12) | 50 percentage of participants |