Chronic Hepatitis C
Conditions
Keywords
HCV, GT1
Brief summary
Open label phase 2a study of two week treatment with CDI-31244 and sofosbuvir and veltapasvir followed by four week treatment of sofosbuvir and velpatasvir in individuals with chronic hepatitis C (HCV) genotype 1 (GT1) infection
Detailed description
The study is open label and has one treatment group. Eligible HCV GT1 subjects will self administer orally 400 mg of CDI-31244 and fixed dose combination of sofosbuvir and velpatasvir for 14 days. After 14 days the subjects will continue the treatment for another 4 weeks on the fixed dose combination sofosbuvir and velpatasvir. The subjects will be followed up until 24 weeks after the last dose of sofosbuvir and velpatasvir to determine if sustained virologic response at 12 (SVR12) and 24 (SVR24) weeks after treatment have been achieved.
Interventions
DRUGCDI-31244
investigational drug
DRUGSOF/VEL
sofosbuvir and velpatasvir fixed dose combination
Sponsors
Cocrystal Pharma, 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
Key Inclusion Criteria: Documented chronic HCV GT 1 infection; Serum HCV RNA \>1,000 IU/mL during screening; Absence of advanced fibrosis or cirrhosis Key
Exclusion criteria
Nursing or pregnant women; Active hepatitis B infection; Human immunodeficiency virus (HIV) infection; History of use of any HCV direct-acting antiviral therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Treatment Emergent Adverse Events | Day 1 to Day 72 | The safety and the tolerability of CDI-31244 in combination with SOF/VEL through number of AEs observed in participants |
| Number of Participants With Sustained Virologic Response (SVR) 12 Weeks After Treatment | post-treatment Week 12 | SVR12 is defined as HCV RNA \< the lower limit of quantitation (LLOQ) at 12 weeks after treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Sustained Virologic Response (SVR) 24 Weeks After Discontinuation of Therapy | post-treatment Week 24 | SVR (sustained virologic response) 24 is defined as HCV RNA \< the lower limit of quantitation (LLOQ) at 24 weeks after treatment |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Subjects number of subjects in the study | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Subjects |
|---|---|
| Age, Continuous | 44.08 years STANDARD_DEVIATION 11.02 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| HCV load | 6.59 log10 IU/mL STANDARD_DEVIATION 0.62 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 7 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 | 1 Participants |
| Race (NIH/OMB) White | 3 Participants |
| Region of Enrollment United States | 12 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 10 / 12 |
| serious Total, serious adverse events | 1 / 6 |
Outcome results
Primary
Number of Participants With Sustained Virologic Response (SVR) 12 Weeks After Treatment
SVR12 is defined as HCV RNA \< the lower limit of quantitation (LLOQ) at 12 weeks after treatment
Time frame: post-treatment Week 12
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CDI-31244 + SOF/VEL | Number of Participants With Sustained Virologic Response (SVR) 12 Weeks After Treatment | 8 Participants |
Primary
Number of Subjects With Treatment Emergent Adverse Events
The safety and the tolerability of CDI-31244 in combination with SOF/VEL through number of AEs observed in participants
Time frame: Day 1 to Day 72
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CDI-31244 + SOF/VEL | Number of Subjects With Treatment Emergent Adverse Events | 10 Participants |
Secondary
Number of Participants With Sustained Virologic Response (SVR) 24 Weeks After Discontinuation of Therapy
SVR (sustained virologic response) 24 is defined as HCV RNA \< the lower limit of quantitation (LLOQ) at 24 weeks after treatment
Time frame: post-treatment Week 24
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CDI-31244 + SOF/VEL | Number of Participants With Sustained Virologic Response (SVR) 24 Weeks After Discontinuation of Therapy | 8 Participants |