Trial Outcomes & Findings for Evaluation of Safety, Tolerability, and Antiviral Activity of Chlorcyclizine HCl in Patients With Chronic Hepatitis C (NCT NCT02118012)
NCT ID: NCT02118012
Last Updated: 2020-06-09
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
24 participants
Primary outcome timeframe
Baseline and 28 days
Results posted on
2020-06-09
Participant Flow
Participant milestones
| Measure |
Chlorcyclizine and RBV
Chlorcyclizine HCl and Ribavirin
Chlorcyclizine HCL plus Ribavirin: RBV+ chlorcyclizine HCl (75 mg twice daily)
|
Chlorcyclizine HCl Only
chlorcyclizine HCl (75 mg twice daily)
Chlorcyclizine HCL Only: chlorcyclizine HCl (75 mg twice daily)
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
Day 5
|
12
|
11
|
|
Overall Study
Day 14
|
12
|
10
|
|
Overall Study
COMPLETED
|
12
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Chlorcyclizine and RBV
Chlorcyclizine HCl and Ribavirin
Chlorcyclizine HCL plus Ribavirin: RBV+ chlorcyclizine HCl (75 mg twice daily)
|
Chlorcyclizine HCl Only
chlorcyclizine HCl (75 mg twice daily)
Chlorcyclizine HCL Only: chlorcyclizine HCl (75 mg twice daily)
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
Evaluation of Safety, Tolerability, and Antiviral Activity of Chlorcyclizine HCl in Patients With Chronic Hepatitis C
Baseline characteristics by cohort
| Measure |
Chlorcyclizine and RBV
n=12 Participants
Chlorcyclizine HCl and Ribavirin
Chlorcyclizine HCL plus Ribavirin: RBV+ chlorcyclizine HCl (75 mg twice daily)
|
Chlorcyclizine HCl Only
n=12 Participants
chlorcyclizine HCl (75 mg twice daily)
Chlorcyclizine HCL Only: chlorcyclizine HCl (75 mg twice daily)
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56 years
n=5 Participants
|
57 years
n=7 Participants
|
56 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
HCV Genotype
1A
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
HCV Genotype
1B
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
HCV Genotype
2
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
HCV Genotype
3
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
HCV Genotype
4
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
HCV Genotype
6
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 28 daysOutcome measures
| Measure |
Chlorcyclizine and RBV
n=12 Participants
Chlorcyclizine HCl and Ribavirin
Chlorcyclizine HCL plus Ribavirin: RBV+ chlorcyclizine HCl (75 mg twice daily)
|
Chlorcyclizine HCl Only
n=10 Participants
chlorcyclizine HCl (75 mg twice daily)
Chlorcyclizine HCL Only: chlorcyclizine HCl (75 mg twice daily)
|
|---|---|---|
|
Change in Serum HCV RNA Viral Titer From Baseline to 28 Days
|
-0.46 log IU/ml
Interval -0.83 to -0.04
|
-0.11 log IU/ml
Interval -0.21 to 0.21
|
PRIMARY outcome
Timeframe: 28 daysOutcome measures
| Measure |
Chlorcyclizine and RBV
n=12 Participants
Chlorcyclizine HCl and Ribavirin
Chlorcyclizine HCL plus Ribavirin: RBV+ chlorcyclizine HCl (75 mg twice daily)
|
Chlorcyclizine HCl Only
n=12 Participants
chlorcyclizine HCl (75 mg twice daily)
Chlorcyclizine HCL Only: chlorcyclizine HCl (75 mg twice daily)
|
|---|---|---|
|
Number of Participants Who Tolerated the Drug at the Prescribed Dose for the Duration of Therapy
|
12 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Baseline and 28 daysOutcome measures
| Measure |
Chlorcyclizine and RBV
n=12 Participants
Chlorcyclizine HCl and Ribavirin
Chlorcyclizine HCL plus Ribavirin: RBV+ chlorcyclizine HCl (75 mg twice daily)
|
Chlorcyclizine HCl Only
n=10 Participants
chlorcyclizine HCl (75 mg twice daily)
Chlorcyclizine HCL Only: chlorcyclizine HCl (75 mg twice daily)
|
|---|---|---|
|
Change in Alanine Aminotransferase (ALT) Levels From Baseline to 28 Days
|
26 U/L
Interval 5.75 to 45.25
|
6 U/L
Interval 0.5 to 15.0
|
SECONDARY outcome
Timeframe: Weeks 1-4Population: Concentration measurements were not available for 1 Chlorcyclizine and RBV participant and for the 2 Chlorcyclizine HCl only participants who withdrew from the study
Chlorcyclizine HCL concentration was measured once a week in the morning. This outcome is the maximum over the four weeks.
Outcome measures
| Measure |
Chlorcyclizine and RBV
n=11 Participants
Chlorcyclizine HCl and Ribavirin
Chlorcyclizine HCL plus Ribavirin: RBV+ chlorcyclizine HCl (75 mg twice daily)
|
Chlorcyclizine HCl Only
n=10 Participants
chlorcyclizine HCl (75 mg twice daily)
Chlorcyclizine HCL Only: chlorcyclizine HCl (75 mg twice daily)
|
|---|---|---|
|
Maximum Chlorcyclizine HCL Weeks 1-4
|
211 ng/ml
Interval 125.0 to 240.0
|
251 ng/ml
Interval 153.0 to 285.0
|
Adverse Events
Chlorcyclizine and RBV
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Chlorcyclizine HCl Only
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Chlorcyclizine and RBV
n=12 participants at risk
Chlorcyclizine HCl and Ribavirin
Chlorcyclizine HCL plus Ribavirin: RBV+ chlorcyclizine HCl (75 mg twice daily)
|
Chlorcyclizine HCl Only
n=12 participants at risk
chlorcyclizine HCl (75 mg twice daily)
Chlorcyclizine HCL Only: chlorcyclizine HCl (75 mg twice daily)
|
|---|---|---|
|
General disorders
Drowsiness
|
50.0%
6/12 • 28 days
Monitoring of adverse events was performed from the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 with modification for patients with liver disease.
|
41.7%
5/12 • 28 days
Monitoring of adverse events was performed from the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 with modification for patients with liver disease.
|
|
Gastrointestinal disorders
Dry Mouth
|
75.0%
9/12 • 28 days
Monitoring of adverse events was performed from the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 with modification for patients with liver disease.
|
83.3%
10/12 • 28 days
Monitoring of adverse events was performed from the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 with modification for patients with liver disease.
|
|
General disorders
Light Headedness
|
16.7%
2/12 • 28 days
Monitoring of adverse events was performed from the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 with modification for patients with liver disease.
|
33.3%
4/12 • 28 days
Monitoring of adverse events was performed from the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 with modification for patients with liver disease.
|
|
Nervous system disorders
Nervousness
|
50.0%
6/12 • 28 days
Monitoring of adverse events was performed from the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 with modification for patients with liver disease.
|
16.7%
2/12 • 28 days
Monitoring of adverse events was performed from the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 with modification for patients with liver disease.
|
|
Psychiatric disorders
Inability to concentrate
|
33.3%
4/12 • 28 days
Monitoring of adverse events was performed from the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 with modification for patients with liver disease.
|
25.0%
3/12 • 28 days
Monitoring of adverse events was performed from the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 with modification for patients with liver disease.
|
|
Gastrointestinal disorders
Nausea
|
8.3%
1/12 • 28 days
Monitoring of adverse events was performed from the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 with modification for patients with liver disease.
|
0.00%
0/12 • 28 days
Monitoring of adverse events was performed from the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 with modification for patients with liver disease.
|
|
Nervous system disorders
Headaches
|
16.7%
2/12 • 28 days
Monitoring of adverse events was performed from the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 with modification for patients with liver disease.
|
16.7%
2/12 • 28 days
Monitoring of adverse events was performed from the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 with modification for patients with liver disease.
|
|
Nervous system disorders
Numbness or Tingling
|
16.7%
2/12 • 28 days
Monitoring of adverse events was performed from the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 with modification for patients with liver disease.
|
25.0%
3/12 • 28 days
Monitoring of adverse events was performed from the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 with modification for patients with liver disease.
|
|
Renal and urinary disorders
Difficulty Urinating
|
16.7%
2/12 • 28 days
Monitoring of adverse events was performed from the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 with modification for patients with liver disease.
|
8.3%
1/12 • 28 days
Monitoring of adverse events was performed from the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 with modification for patients with liver disease.
|
|
General disorders
Fatigue
|
25.0%
3/12 • 28 days
Monitoring of adverse events was performed from the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 with modification for patients with liver disease.
|
16.7%
2/12 • 28 days
Monitoring of adverse events was performed from the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 with modification for patients with liver disease.
|
Additional Information
Christopher Koh, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Phone: (301) 443-9402
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place