Trial Outcomes & Findings for A Phase 1/2 Study of CF102 in Patients With Chronic Hepatitis C Genotype 1 (NCT NCT00790673)
NCT ID: NCT00790673
Last Updated: 2015-04-15
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
32 participants
Primary outcome timeframe
16 weeks
Results posted on
2015-04-15
Participant Flow
Participant milestones
| Measure |
Cohort 1 CF102 1 mg qd
CF102 1 mg qd
CF 102: Oral capsules
|
Cohort 2 CF102 1 mg Bid
CF102 1 mg bid
CF 102: Oral capsules
|
Cohort 3 CF102 1 mg Bid
CF102 1 mg bid; 16 weeks
CF 102: Oral capsules
|
Placebo
Placebo: Matching placebo capsules
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
12
|
8
|
|
Overall Study
COMPLETED
|
6
|
6
|
12
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase 1/2 Study of CF102 in Patients With Chronic Hepatitis C Genotype 1
Baseline characteristics by cohort
| Measure |
Cohort 1 CF102 1 mg qd
n=6 Participants
CF102 1 mg qd
CF 102: Oral capsules
|
Cohort 2 CF102 1 mg Bid
n=6 Participants
CF102 1 mg bid
CF 102: Oral capsules
|
Cohort 3 CF102 1 mg Bid
n=12 Participants
CF102 1 mg bid; 16 weeks
CF 102: Oral capsules
|
Placebo
n=8 Participants
Placebo: Matching placebo capsules
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
45.3 years
STANDARD_DEVIATION 12.7 • n=99 Participants
|
54.5 years
STANDARD_DEVIATION 8.43 • n=107 Participants
|
48.3 years
STANDARD_DEVIATION 12.4 • n=206 Participants
|
42.1 years
STANDARD_DEVIATION 11.2 • n=7 Participants
|
47.3 years
STANDARD_DEVIATION 11.8 • n=31 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
16 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
16 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 16 weeksOutcome measures
| Measure |
Cohort 1 CF102 1 mg qd
n=6 Participants
CF102 1 mg qd
CF 102: Oral capsules
|
Cohort 2 CF102 1 mg Bid
n=6 Participants
CF102 1 mg bid
CF 102: Oral capsules
|
Cohort 3 CF102 1 mg Bid
n=12 Participants
CF102 1 mg bid; 16 weeks
CF 102: Oral capsules
|
Placebo
n=8 Participants
Placebo: Matching placebo capsules
|
|---|---|---|---|---|
|
Adverse Event Profile of Repeated Dosing of CF102
|
6 participants
|
2 participants
|
2 participants
|
4 participants
|
PRIMARY outcome
Timeframe: 16 weeksOutcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 16 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 16 weeksOutcome measures
Outcome data not reported
Adverse Events
Cohort 1 CF102 1 mg qd
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 2 CF102 1 mg Bid
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 3 CF102 1 mg Bid
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1 CF102 1 mg qd
n=6 participants at risk
CF102 1 mg qd
CF 102: Oral capsules
|
Cohort 2 CF102 1 mg Bid
n=6 participants at risk
CF102 1 mg bid
CF 102: Oral capsules
|
Cohort 3 CF102 1 mg Bid
n=12 participants at risk
CF102 1 mg bid; 16 weeks
CF 102: Oral capsules
|
Placebo
n=8 participants at risk
Placebo: Matching placebo capsules
|
|---|---|---|---|---|
|
General disorders
Fatigue
|
33.3%
2/6 • Number of events 6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/8
|
|
Nervous system disorders
HEADACHE
|
66.7%
4/6 • Number of events 6
|
33.3%
2/6 • Number of events 6
|
16.7%
2/12 • Number of events 12
|
50.0%
4/8 • Number of events 8
|
|
Cardiac disorders
Palpitations
|
33.3%
2/6 • Number of events 6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/8
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place