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CTS-1027 in Interferon-Naive Hepatitis C Patients

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ClinicalTrials.gov Identifier: NCT00925990
Recruitment Status : Completed
First Posted : June 23, 2009
Results First Posted : March 27, 2012
Last Update Posted : March 27, 2012
Sponsor:
Information provided by (Responsible Party):
Conatus Pharmaceuticals Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Hepatitis C
Interventions Drug: ribavirin
Drug: CTS-1027
Drug: Placebo for ribavirin
Enrollment 70
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CTS-1027 + Ribavirin CTS-1027 + Placebo
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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, 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.

Period Title: Overall Study
Started 35 35
Completed 30 24
Not Completed 5 11
Reason Not Completed
Adverse Event             1             3
Withdrawal by Subject             2             2
Lost to Follow-up             1             3
Physician Decision             1             1
moved out of state, missed medication             0             2
Arm/Group Title CTS-1027 + Ribavirin CTS-1027 + Placebo Total
Hide Arm/Group Description

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, 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 of all reporting groups
Overall Number of Baseline Participants 35 35 70
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 35 participants 70 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
33
  94.3%
35
 100.0%
68
  97.1%
>=65 years
2
   5.7%
0
   0.0%
2
   2.9%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 35 participants 35 participants 70 participants
52.6  (6.8) 49.7  (9.1) 51.2  (8.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 35 participants 70 participants
Female
12
  34.3%
9
  25.7%
21
  30.0%
Male
23
  65.7%
26
  74.3%
49
  70.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 35 participants 35 participants 70 participants
United States 34 31 65
Puerto Rico 1 4 5
1.Primary Outcome
Title Mean Change in HCV-RNA (Hepatitis C Virus Ribonucleic Acid) Levels From Baseline Through 24 Weeks of Treatment
Hide Description

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)

Time Frame Baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients receiving at least one dose of study drug were analyzed for safety.
Arm/Group Title CTS-1027 + Ribavirin CTS-1027 + Placebo
Hide Arm/Group Description:

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, 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 Number of Participants Analyzed 35 35
Mean (Standard Deviation)
Unit of Measure: log (IU/mL)
-0.48  (0.50) -0.12  (0.76)
2.Secondary Outcome
Title Mean Change in Aminotransferases From Baseline to 24 Weeks of Treatment
Hide Description

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)

Time Frame Baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients dosed with at least one dose of study drug were analyzed.
Arm/Group Title CTS-1027 + Ribavirin CTS-1027 + Placebo
Hide Arm/Group Description:

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, 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 Number of Participants Analyzed 35 35
Mean (Standard Deviation)
Unit of Measure: IU/mL
-15.6  (42.9) -16.5  (65.5)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CTS-1027 + Ribavirin CTS-1027 + Placebo
Hide Arm/Group Description

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, 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.

All-Cause Mortality
CTS-1027 + Ribavirin CTS-1027 + Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
CTS-1027 + Ribavirin CTS-1027 + Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/35 (8.57%)      6/35 (17.14%)    
Blood and lymphatic system disorders     
anemia  1  0/35 (0.00%)  0 1/35 (2.86%)  1
Gastrointestinal disorders     
colitis ulcerative  1  1/35 (2.86%)  2 0/35 (0.00%)  0
hematemesis  1  0/35 (0.00%)  0 1/35 (2.86%)  1
upper GI hemorrhage  1  0/35 (0.00%)  0 1/35 (2.86%)  1
General disorders     
chest pain  1  0/35 (0.00%)  0 1/35 (2.86%)  1
Infections and infestations     
lobar pneumonia  1  1/35 (2.86%)  2 0/35 (0.00%)  0
staphylococcal abscess  1  0/35 (0.00%)  0 1/35 (2.86%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
prostate cancer  1  0/35 (0.00%)  0 1/35 (2.86%)  1
Nervous system disorders     
spondylitic myelopathy  1  1/35 (2.86%)  1 0/35 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
chronic obstructive pulmonary disease  1  0/35 (0.00%)  0 1/35 (2.86%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
CTS-1027 + Ribavirin CTS-1027 + Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   31/35 (88.57%)      29/35 (82.86%)    
Blood and lymphatic system disorders     
anemia  1  6/35 (17.14%)  6 0/35 (0.00%)  0
Gastrointestinal disorders     
abdominal discomfort  1  2/35 (5.71%)  2 0/35 (0.00%)  0
dyspepsia  1  2/35 (5.71%)  2 2/35 (5.71%)  2
nausea  1  2/35 (5.71%)  2 3/35 (8.57%)  3
vomiting  1  3/35 (8.57%)  5 1/35 (2.86%)  1
diarrhea  1  3/35 (8.57%)  4 1/35 (2.86%)  2
constipation  1  2/35 (5.71%)  3 1/35 (2.86%)  1
General disorders     
fatigue  1  11/35 (31.43%)  12 8/35 (22.86%)  8
edema peripheral  1  2/35 (5.71%)  2 0/35 (0.00%)  0
Metabolism and nutrition disorders     
decreased appetite  1  3/35 (8.57%)  3 2/35 (5.71%)  2
Musculoskeletal and connective tissue disorders     
back pain  1  2/35 (5.71%)  2 2/35 (5.71%)  3
joint range of motion decreased  1  3/35 (8.57%)  3 1/35 (2.86%)  1
joint stiffness  1  1/35 (2.86%)  1 5/35 (14.29%)  6
joint swelling  1  2/35 (5.71%)  2 0/35 (0.00%)  0
muscle spasms  1  2/35 (5.71%)  2 0/35 (0.00%)  0
muscular weakness  1  1/35 (2.86%)  1 2/35 (5.71%)  2
musculoskeletal pain  1  5/35 (14.29%)  6 3/35 (8.57%)  3
musculoskeletal stiffness  1  2/35 (5.71%)  3 2/35 (5.71%)  3
myalgia  1  4/35 (11.43%)  6 4/35 (11.43%)  4
pain in extremity  1  1/35 (2.86%)  2 3/35 (8.57%)  3
arthralgia   7/35 (20.00%)  9 12/35 (34.29%)  23
Nervous system disorders     
dizziness  1  2/35 (5.71%)  2 2/35 (5.71%)  2
headache  1  5/35 (14.29%)  6 5/35 (14.29%)  5
Psychiatric disorders     
insomnia  1  5/35 (14.29%)  6 0/35 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
cough  1  3/35 (8.57%)  3 2/35 (5.71%)  2
dyspnea  1  2/35 (5.71%)  2 0/35 (0.00%)  0
Skin and subcutaneous tissue disorders     
alopecia  1  2/35 (5.71%)  2 1/35 (2.86%)  1
pruritus  1  3/35 (8.57%)  5 1/35 (2.86%)  1
rash  1  0/35 (0.00%)  0 2/35 (5.71%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Vice President, Clinical Development
Organization: Conatus Pharmaceuticals Inc.
Phone: 858-457-7227
EMail: mhuyghe@conatuspharma.com
Layout table for additonal information
Responsible Party: Conatus Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00925990     History of Changes
Other Study ID Numbers: CTS-1027-03
First Submitted: June 19, 2009
First Posted: June 23, 2009
Results First Submitted: February 9, 2012
Results First Posted: March 27, 2012
Last Update Posted: March 27, 2012