Trial Outcomes & Findings for Study of CTS-1027 in Combination With Pegylated Interferon and Ribavirin in Hepatitis C Virus (HCV) Null-Responders (NCT NCT01051921)
NCT ID: NCT01051921
Last Updated: 2012-04-16
Results Overview
Early Virologic Response (EVR) is defined as the percent of patients who experienced a drop in HCV-RNA (Hepatitis C Ribonucleic acid, also known as "viral load") levels of more that 2 log from before treatment (baseline) through 12 Weeks of treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
67 participants
Primary outcome timeframe
Baseline and Study week 12
Results posted on
2012-04-16
Participant Flow
Participant milestones
| Measure |
CTS-1027, Pegylated Interferon, Ribavirin
CTS-1027 plus Pegylated Interferon plus ribavirin
|
|---|---|
|
Overall Study
STARTED
|
67
|
|
Overall Study
COMPLETED
|
37
|
|
Overall Study
NOT COMPLETED
|
30
|
Reasons for withdrawal
| Measure |
CTS-1027, Pegylated Interferon, Ribavirin
CTS-1027 plus Pegylated Interferon plus ribavirin
|
|---|---|
|
Overall Study
Physician Decision
|
9
|
|
Overall Study
Adverse Event
|
8
|
|
Overall Study
Withdrawal by Subject
|
7
|
|
Overall Study
Lost to Follow-up
|
4
|
|
Overall Study
virological failure
|
1
|
|
Overall Study
patient moved
|
1
|
Baseline Characteristics
Study of CTS-1027 in Combination With Pegylated Interferon and Ribavirin in Hepatitis C Virus (HCV) Null-Responders
Baseline characteristics by cohort
| Measure |
CTS-1027, Pegylated Interferon, Ribavirin
n=67 Participants
CTS-1027 plus Pegylated Interferon plus ribavirin
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
65 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Age Continuous
|
52.1 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
67 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Study week 12Population: Although this study was completed, the entire CTS-1027 program was discontinued prior to database lock. Therefore, efficacy analysis was not completed for this study.
Early Virologic Response (EVR) is defined as the percent of patients who experienced a drop in HCV-RNA (Hepatitis C Ribonucleic acid, also known as "viral load") levels of more that 2 log from before treatment (baseline) through 12 Weeks of treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Study week 24Population: Although this study was completed, the entire CTS-1027 program was discontinued prior to database lock. Therefore, efficacy analysis was not completed for this study.
Percent of patients experiencing a drop in HCV-RNA Hepatitis C virus ribonucleic acid, also known as "viral load") levels in the blood equal to, or greater than, 2 log from before treatment (baseline) through 24 weeks of treatment.
Outcome measures
Outcome data not reported
Adverse Events
CTS-1027, Pegylated Interferon, Ribavirin
Serious events: 7 serious events
Other events: 63 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CTS-1027, Pegylated Interferon, Ribavirin
n=67 participants at risk
CTS-1027 plus Pegylated Interferon plus ribavirin
|
|---|---|
|
Infections and infestations
Appendicitis
|
1.5%
1/67 • Number of events 1 • Day 1 of dosing through 12 week follow-up visit (up to 60 weeks).
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) by the Investigator. All serious adverse events are reported regardless of causality.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Oncocytoma
|
1.5%
1/67 • Number of events 1 • Day 1 of dosing through 12 week follow-up visit (up to 60 weeks).
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) by the Investigator. All serious adverse events are reported regardless of causality.
|
|
Infections and infestations
Pyelonephritis
|
1.5%
1/67 • Number of events 1 • Day 1 of dosing through 12 week follow-up visit (up to 60 weeks).
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) by the Investigator. All serious adverse events are reported regardless of causality.
|
|
Gastrointestinal disorders
Inguinal hernia, obstructive
|
1.5%
1/67 • Number of events 1 • Day 1 of dosing through 12 week follow-up visit (up to 60 weeks).
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) by the Investigator. All serious adverse events are reported regardless of causality.
|
|
General disorders
Chest Pain
|
1.5%
1/67 • Number of events 1 • Day 1 of dosing through 12 week follow-up visit (up to 60 weeks).
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) by the Investigator. All serious adverse events are reported regardless of causality.
|
|
Gastrointestinal disorders
Vomiting
|
1.5%
1/67 • Number of events 1 • Day 1 of dosing through 12 week follow-up visit (up to 60 weeks).
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) by the Investigator. All serious adverse events are reported regardless of causality.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
1.5%
1/67 • Number of events 1 • Day 1 of dosing through 12 week follow-up visit (up to 60 weeks).
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) by the Investigator. All serious adverse events are reported regardless of causality.
|
|
Hepatobiliary disorders
Cholecystitis
|
1.5%
1/67 • Number of events 1 • Day 1 of dosing through 12 week follow-up visit (up to 60 weeks).
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) by the Investigator. All serious adverse events are reported regardless of causality.
|
Other adverse events
| Measure |
CTS-1027, Pegylated Interferon, Ribavirin
n=67 participants at risk
CTS-1027 plus Pegylated Interferon plus ribavirin
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
26.9%
18/67 • Number of events 31 • Day 1 of dosing through 12 week follow-up visit (up to 60 weeks).
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) by the Investigator. All serious adverse events are reported regardless of causality.
|
|
Blood and lymphatic system disorders
Neutropenia
|
16.4%
11/67 • Number of events 15 • Day 1 of dosing through 12 week follow-up visit (up to 60 weeks).
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) by the Investigator. All serious adverse events are reported regardless of causality.
|
|
Gastrointestinal disorders
Diarrhea
|
11.9%
8/67 • Number of events 11 • Day 1 of dosing through 12 week follow-up visit (up to 60 weeks).
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) by the Investigator. All serious adverse events are reported regardless of causality.
|
|
Gastrointestinal disorders
Dry mouth
|
9.0%
6/67 • Number of events 6 • Day 1 of dosing through 12 week follow-up visit (up to 60 weeks).
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) by the Investigator. All serious adverse events are reported regardless of causality.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.5%
5/67 • Number of events 7 • Day 1 of dosing through 12 week follow-up visit (up to 60 weeks).
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) by the Investigator. All serious adverse events are reported regardless of causality.
|
|
Gastrointestinal disorders
Vomiting
|
6.0%
4/67 • Number of events 4 • Day 1 of dosing through 12 week follow-up visit (up to 60 weeks).
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) by the Investigator. All serious adverse events are reported regardless of causality.
|
|
General disorders
Chills
|
13.4%
9/67 • Number of events 9 • Day 1 of dosing through 12 week follow-up visit (up to 60 weeks).
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) by the Investigator. All serious adverse events are reported regardless of causality.
|
|
General disorders
Fatigue
|
56.7%
38/67 • Number of events 62 • Day 1 of dosing through 12 week follow-up visit (up to 60 weeks).
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) by the Investigator. All serious adverse events are reported regardless of causality.
|
|
General disorders
Influenza like illness
|
11.9%
8/67 • Number of events 10 • Day 1 of dosing through 12 week follow-up visit (up to 60 weeks).
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) by the Investigator. All serious adverse events are reported regardless of causality.
|
|
General disorders
Injection site reaction
|
6.0%
4/67 • Number of events 4 • Day 1 of dosing through 12 week follow-up visit (up to 60 weeks).
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) by the Investigator. All serious adverse events are reported regardless of causality.
|
|
General disorders
Irritability
|
16.4%
11/67 • Number of events 17 • Day 1 of dosing through 12 week follow-up visit (up to 60 weeks).
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) by the Investigator. All serious adverse events are reported regardless of causality.
|
|
General disorders
Pain
|
6.0%
4/67 • Number of events 4 • Day 1 of dosing through 12 week follow-up visit (up to 60 weeks).
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) by the Investigator. All serious adverse events are reported regardless of causality.
|
|
General disorders
Pyrexia
|
11.9%
8/67 • Number of events 11 • Day 1 of dosing through 12 week follow-up visit (up to 60 weeks).
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) by the Investigator. All serious adverse events are reported regardless of causality.
|
|
Infections and infestations
Sinusitis
|
6.0%
4/67 • Number of events 4 • Day 1 of dosing through 12 week follow-up visit (up to 60 weeks).
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) by the Investigator. All serious adverse events are reported regardless of causality.
|
|
Investigations
Wieght decreased
|
6.0%
4/67 • Number of events 6 • Day 1 of dosing through 12 week follow-up visit (up to 60 weeks).
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) by the Investigator. All serious adverse events are reported regardless of causality.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
13.4%
9/67 • Number of events 9 • Day 1 of dosing through 12 week follow-up visit (up to 60 weeks).
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) by the Investigator. All serious adverse events are reported regardless of causality.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
38.8%
26/67 • Number of events 58 • Day 1 of dosing through 12 week follow-up visit (up to 60 weeks).
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) by the Investigator. All serious adverse events are reported regardless of causality.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.0%
4/67 • Number of events 7 • Day 1 of dosing through 12 week follow-up visit (up to 60 weeks).
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) by the Investigator. All serious adverse events are reported regardless of causality.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
6.0%
4/67 • Number of events 7 • Day 1 of dosing through 12 week follow-up visit (up to 60 weeks).
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) by the Investigator. All serious adverse events are reported regardless of causality.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.0%
4/67 • Number of events 4 • Day 1 of dosing through 12 week follow-up visit (up to 60 weeks).
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) by the Investigator. All serious adverse events are reported regardless of causality.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.0%
4/67 • Number of events 9 • Day 1 of dosing through 12 week follow-up visit (up to 60 weeks).
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) by the Investigator. All serious adverse events are reported regardless of causality.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
6.0%
4/67 • Number of events 7 • Day 1 of dosing through 12 week follow-up visit (up to 60 weeks).
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) by the Investigator. All serious adverse events are reported regardless of causality.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
19.4%
13/67 • Number of events 30 • Day 1 of dosing through 12 week follow-up visit (up to 60 weeks).
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) by the Investigator. All serious adverse events are reported regardless of causality.
|
|
Nervous system disorders
Disturbance in attention
|
9.0%
6/67 • Number of events 6 • Day 1 of dosing through 12 week follow-up visit (up to 60 weeks).
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) by the Investigator. All serious adverse events are reported regardless of causality.
|
|
Nervous system disorders
Dizziness
|
11.9%
8/67 • Number of events 9 • Day 1 of dosing through 12 week follow-up visit (up to 60 weeks).
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) by the Investigator. All serious adverse events are reported regardless of causality.
|
|
Nervous system disorders
Dysgeusia
|
7.5%
5/67 • Number of events 5 • Day 1 of dosing through 12 week follow-up visit (up to 60 weeks).
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) by the Investigator. All serious adverse events are reported regardless of causality.
|
|
Nervous system disorders
Headache
|
35.8%
24/67 • Number of events 38 • Day 1 of dosing through 12 week follow-up visit (up to 60 weeks).
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) by the Investigator. All serious adverse events are reported regardless of causality.
|
|
Psychiatric disorders
Anxiety
|
7.5%
5/67 • Number of events 5 • Day 1 of dosing through 12 week follow-up visit (up to 60 weeks).
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) by the Investigator. All serious adverse events are reported regardless of causality.
|
|
Psychiatric disorders
Depression
|
25.4%
17/67 • Number of events 25 • Day 1 of dosing through 12 week follow-up visit (up to 60 weeks).
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) by the Investigator. All serious adverse events are reported regardless of causality.
|
|
Psychiatric disorders
Insomnia
|
22.4%
15/67 • Number of events 24 • Day 1 of dosing through 12 week follow-up visit (up to 60 weeks).
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) by the Investigator. All serious adverse events are reported regardless of causality.
|
|
Psychiatric disorders
Mood swings
|
6.0%
4/67 • Number of events 6 • Day 1 of dosing through 12 week follow-up visit (up to 60 weeks).
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) by the Investigator. All serious adverse events are reported regardless of causality.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.9%
8/67 • Number of events 8 • Day 1 of dosing through 12 week follow-up visit (up to 60 weeks).
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) by the Investigator. All serious adverse events are reported regardless of causality.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.5%
5/67 • Number of events 7 • Day 1 of dosing through 12 week follow-up visit (up to 60 weeks).
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) by the Investigator. All serious adverse events are reported regardless of causality.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea exertional
|
6.0%
4/67 • Number of events 9 • Day 1 of dosing through 12 week follow-up visit (up to 60 weeks).
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) by the Investigator. All serious adverse events are reported regardless of causality.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
9.0%
6/67 • Number of events 6 • Day 1 of dosing through 12 week follow-up visit (up to 60 weeks).
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) by the Investigator. All serious adverse events are reported regardless of causality.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.9%
10/67 • Number of events 18 • Day 1 of dosing through 12 week follow-up visit (up to 60 weeks).
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) by the Investigator. All serious adverse events are reported regardless of causality.
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.9%
10/67 • Number of events 16 • Day 1 of dosing through 12 week follow-up visit (up to 60 weeks).
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) by the Investigator. All serious adverse events are reported regardless of causality.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
7.5%
5/67 • Number of events 8 • Day 1 of dosing through 12 week follow-up visit (up to 60 weeks).
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) by the Investigator. All serious adverse events are reported regardless of causality.
|
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