Trial Outcomes & Findings for CTS-1027 in Interferon-Naive Hepatitis C Patients (NCT NCT00925990)
NCT ID: NCT00925990
Last Updated: 2012-03-27
Results Overview
Measure the mean absolute changes in HCV-RNA (Hepatitis C virus ribonucleic acid, also known as "viral load") levels in the blood from before treatment (baseline) through 24 weeks of treatment. Mean Absolute Change in HCV-RNA (log) = log10(HCV-RNA Week 24) - log10(HCV-RNA Baseline)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
70 participants
Primary outcome timeframe
Baseline and 24 weeks
Results posted on
2012-03-27
Participant Flow
Participant milestones
| Measure |
CTS-1027 + Ribavirin
CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.
Ribavirin, 200 mg capsules, taken in two divided daily doses totaling 1000 mg daily for patients weighing 75kg or less, and 1200 mg daily for patients weighing more than 75 kg
|
CTS-1027 + Placebo
CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.
Placebo, incactive capsules identical in appearance to ribavirin capusules. Five (for patients weighing 75 kg or less) or six (for patients weighing more than 75 kg) capsules taken in two divided daily doses.
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
35
|
|
Overall Study
COMPLETED
|
30
|
24
|
|
Overall Study
NOT COMPLETED
|
5
|
11
|
Reasons for withdrawal
| Measure |
CTS-1027 + Ribavirin
CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.
Ribavirin, 200 mg capsules, taken in two divided daily doses totaling 1000 mg daily for patients weighing 75kg or less, and 1200 mg daily for patients weighing more than 75 kg
|
CTS-1027 + Placebo
CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.
Placebo, incactive capsules identical in appearance to ribavirin capusules. Five (for patients weighing 75 kg or less) or six (for patients weighing more than 75 kg) capsules taken in two divided daily doses.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
moved out of state, missed medication
|
0
|
2
|
Baseline Characteristics
CTS-1027 in Interferon-Naive Hepatitis C Patients
Baseline characteristics by cohort
| Measure |
CTS-1027 + Ribavirin
n=35 Participants
CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.
Ribavirin, 200 mg capsules, taken in two divided daily doses totaling 1000 mg daily for patients weighing 75kg or less, and 1200 mg daily for patients weighing more than 75 kg
|
CTS-1027 + Placebo
n=35 Participants
CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.
Placebo, incactive capsules identical in appearance to ribavirin capusules. Five (for patients weighing 75 kg or less) or six (for patients weighing more than 75 kg) capsules taken in two divided daily doses.
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
33 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age Continuous
|
52.6 years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
49.7 years
STANDARD_DEVIATION 9.1 • n=7 Participants
|
51.2 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=5 Participants
|
31 participants
n=7 Participants
|
65 participants
n=5 Participants
|
|
Region of Enrollment
Puerto Rico
|
1 participants
n=5 Participants
|
4 participants
n=7 Participants
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 24 weeksPopulation: All patients receiving at least one dose of study drug were analyzed for safety.
Measure the mean absolute changes in HCV-RNA (Hepatitis C virus ribonucleic acid, also known as "viral load") levels in the blood from before treatment (baseline) through 24 weeks of treatment. Mean Absolute Change in HCV-RNA (log) = log10(HCV-RNA Week 24) - log10(HCV-RNA Baseline)
Outcome measures
| Measure |
CTS-1027 + Ribavirin
n=35 Participants
CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.
Ribavirin, 200 mg capsules, taken in two divided daily doses totaling 1000 mg (5 capsules) daily for patients weighing 75kg or less, and 1200 mg (6 capsules) daily for patients weighing more than 75 kg
|
CTS-1027 + Placebo
n=35 Participants
CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.
Placebo, incactive capsules identical in appearance to ribavirin capusules. Five (for patients weighing 75 kg or less) or six (for patients weighing more than 75 kg) capsules taken in two divided daily doses.
|
|---|---|---|
|
Mean Change in HCV-RNA (Hepatitis C Virus Ribonucleic Acid) Levels From Baseline Through 24 Weeks of Treatment
|
-0.48 log (IU/mL)
Standard Deviation 0.50
|
-0.12 log (IU/mL)
Standard Deviation 0.76
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksPopulation: All patients dosed with at least one dose of study drug were analyzed.
Mean absolute changes in ALT (alanine aminotransferase)in the blood from before treatment (baseline)through 24 weeks of treatment are presented. Mean absolute change in ALT (IU/ml)= ALT(Week 24) - ALT(baseline)
Outcome measures
| Measure |
CTS-1027 + Ribavirin
n=35 Participants
CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.
Ribavirin, 200 mg capsules, taken in two divided daily doses totaling 1000 mg (5 capsules) daily for patients weighing 75kg or less, and 1200 mg (6 capsules) daily for patients weighing more than 75 kg
|
CTS-1027 + Placebo
n=35 Participants
CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.
Placebo, incactive capsules identical in appearance to ribavirin capusules. Five (for patients weighing 75 kg or less) or six (for patients weighing more than 75 kg) capsules taken in two divided daily doses.
|
|---|---|---|
|
Mean Change in Aminotransferases From Baseline to 24 Weeks of Treatment
|
-15.6 IU/mL
Standard Deviation 42.9
|
-16.5 IU/mL
Standard Deviation 65.5
|
Adverse Events
CTS-1027 + Ribavirin
Serious events: 3 serious events
Other events: 31 other events
Deaths: 0 deaths
CTS-1027 + Placebo
Serious events: 6 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CTS-1027 + Ribavirin
n=35 participants at risk
CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.
Ribavirin, 200 mg capsules, taken in two divided daily doses totaling 1000 mg daily for patients weighing 75kg or less, and 1200 mg daily for patients weighing more than 75 kg
|
CTS-1027 + Placebo
n=35 participants at risk
CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.
Placebo, incactive capsules identical in appearance to ribavirin capusules. Five (for patients weighing 75 kg or less) or six (for patients weighing more than 75 kg) capsules taken in two divided daily doses.
|
|---|---|---|
|
Gastrointestinal disorders
colitis ulcerative
|
2.9%
1/35 • Number of events 2
|
0.00%
0/35
|
|
Infections and infestations
lobar pneumonia
|
2.9%
1/35 • Number of events 2
|
0.00%
0/35
|
|
Nervous system disorders
spondylitic myelopathy
|
2.9%
1/35 • Number of events 1
|
0.00%
0/35
|
|
Respiratory, thoracic and mediastinal disorders
chronic obstructive pulmonary disease
|
0.00%
0/35
|
2.9%
1/35 • Number of events 1
|
|
Infections and infestations
staphylococcal abscess
|
0.00%
0/35
|
2.9%
1/35 • Number of events 1
|
|
General disorders
chest pain
|
0.00%
0/35
|
2.9%
1/35 • Number of events 1
|
|
Blood and lymphatic system disorders
anemia
|
0.00%
0/35
|
2.9%
1/35 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
prostate cancer
|
0.00%
0/35
|
2.9%
1/35 • Number of events 1
|
|
Gastrointestinal disorders
hematemesis
|
0.00%
0/35
|
2.9%
1/35 • Number of events 1
|
|
Gastrointestinal disorders
upper GI hemorrhage
|
0.00%
0/35
|
2.9%
1/35 • Number of events 1
|
Other adverse events
| Measure |
CTS-1027 + Ribavirin
n=35 participants at risk
CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.
Ribavirin, 200 mg capsules, taken in two divided daily doses totaling 1000 mg daily for patients weighing 75kg or less, and 1200 mg daily for patients weighing more than 75 kg
|
CTS-1027 + Placebo
n=35 participants at risk
CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.
Placebo, incactive capsules identical in appearance to ribavirin capusules. Five (for patients weighing 75 kg or less) or six (for patients weighing more than 75 kg) capsules taken in two divided daily doses.
|
|---|---|---|
|
Blood and lymphatic system disorders
anemia
|
17.1%
6/35 • Number of events 6
|
0.00%
0/35
|
|
Gastrointestinal disorders
abdominal discomfort
|
5.7%
2/35 • Number of events 2
|
0.00%
0/35
|
|
Gastrointestinal disorders
dyspepsia
|
5.7%
2/35 • Number of events 2
|
5.7%
2/35 • Number of events 2
|
|
Gastrointestinal disorders
nausea
|
5.7%
2/35 • Number of events 2
|
8.6%
3/35 • Number of events 3
|
|
Gastrointestinal disorders
vomiting
|
8.6%
3/35 • Number of events 5
|
2.9%
1/35 • Number of events 1
|
|
Gastrointestinal disorders
diarrhea
|
8.6%
3/35 • Number of events 4
|
2.9%
1/35 • Number of events 2
|
|
Gastrointestinal disorders
constipation
|
5.7%
2/35 • Number of events 3
|
2.9%
1/35 • Number of events 1
|
|
General disorders
fatigue
|
31.4%
11/35 • Number of events 12
|
22.9%
8/35 • Number of events 8
|
|
General disorders
edema peripheral
|
5.7%
2/35 • Number of events 2
|
0.00%
0/35
|
|
Metabolism and nutrition disorders
decreased appetite
|
8.6%
3/35 • Number of events 3
|
5.7%
2/35 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
back pain
|
5.7%
2/35 • Number of events 2
|
5.7%
2/35 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
joint range of motion decreased
|
8.6%
3/35 • Number of events 3
|
2.9%
1/35 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
joint stiffness
|
2.9%
1/35 • Number of events 1
|
14.3%
5/35 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
joint swelling
|
5.7%
2/35 • Number of events 2
|
0.00%
0/35
|
|
Musculoskeletal and connective tissue disorders
muscle spasms
|
5.7%
2/35 • Number of events 2
|
0.00%
0/35
|
|
Musculoskeletal and connective tissue disorders
muscular weakness
|
2.9%
1/35 • Number of events 1
|
5.7%
2/35 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal pain
|
14.3%
5/35 • Number of events 6
|
8.6%
3/35 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal stiffness
|
5.7%
2/35 • Number of events 3
|
5.7%
2/35 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
11.4%
4/35 • Number of events 6
|
11.4%
4/35 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
pain in extremity
|
2.9%
1/35 • Number of events 2
|
8.6%
3/35 • Number of events 3
|
|
Nervous system disorders
dizziness
|
5.7%
2/35 • Number of events 2
|
5.7%
2/35 • Number of events 2
|
|
Psychiatric disorders
insomnia
|
14.3%
5/35 • Number of events 6
|
0.00%
0/35
|
|
Nervous system disorders
headache
|
14.3%
5/35 • Number of events 6
|
14.3%
5/35 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
8.6%
3/35 • Number of events 3
|
5.7%
2/35 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
5.7%
2/35 • Number of events 2
|
0.00%
0/35
|
|
Skin and subcutaneous tissue disorders
alopecia
|
5.7%
2/35 • Number of events 2
|
2.9%
1/35 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
pruritus
|
8.6%
3/35 • Number of events 5
|
2.9%
1/35 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
rash
|
0.00%
0/35
|
5.7%
2/35 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
20.0%
7/35 • Number of events 9
|
34.3%
12/35 • Number of events 23
|
Additional Information
Vice President, Clinical Development
Conatus Pharmaceuticals Inc.
Phone: 858-457-7227
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60