Trial Outcomes & Findings for Study of SCY-635, Pegasys and Copegus in Hepatitis C (NCT NCT01265511)
NCT ID: NCT01265511
Last Updated: 2017-08-18
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
Week 4
Results posted on
2017-08-18
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo + PegIFN + RBV for 4 weeks followed by PegIFN + RBV for 20 weeks
Placebo: Oral tablets given bid for 28 days
peginterferon alfa 2a: 180 ug prefilled syringe given once per week for up to 48 weeks
Ribavirin: tablets given bid for up to 48 weeks
|
SCY-635 600 mg
SCY-635 600 mg + PegIFN + RBV for 4 weeks followed by PegIFN + RBV for 20 weeks
SCY-635: SCY-635 tablets, 300 mg bid for 28 days
peginterferon alfa 2a: 180 ug prefilled syringe given once per week for up to 48 weeks
Ribavirin: tablets given bid for up to 48 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
8
|
|
Overall Study
COMPLETED
|
0
|
5
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
Placebo
Placebo + PegIFN + RBV for 4 weeks followed by PegIFN + RBV for 20 weeks
Placebo: Oral tablets given bid for 28 days
peginterferon alfa 2a: 180 ug prefilled syringe given once per week for up to 48 weeks
Ribavirin: tablets given bid for up to 48 weeks
|
SCY-635 600 mg
SCY-635 600 mg + PegIFN + RBV for 4 weeks followed by PegIFN + RBV for 20 weeks
SCY-635: SCY-635 tablets, 300 mg bid for 28 days
peginterferon alfa 2a: 180 ug prefilled syringe given once per week for up to 48 weeks
Ribavirin: tablets given bid for up to 48 weeks
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
2
|
1
|
|
Overall Study
Met stopping rules
|
0
|
2
|
Baseline Characteristics
Study of SCY-635, Pegasys and Copegus in Hepatitis C
Baseline characteristics by cohort
| Measure |
Placebo
n=2 Participants
Placebo + PegIFN + RBV for 4 weeks followed by PegIFN + RBV for 20 weeks
Placebo: Oral tablets given bid for 28 days
peginterferon alfa 2a: 180 ug prefilled syringe given once per week for up to 48 weeks
Ribavirin: tablets given bid for up to 48 weeks
|
SCY-635 600 mg
n=8 Participants
SCY-635 600 mg + PegIFN + RBV for 4 weeks followed by PegIFN + RBV for 20 weeks
SCY-635: SCY-635 tablets, 300 mg bid for 28 days
peginterferon alfa 2a: 180 ug prefilled syringe given once per week for up to 48 weeks
Ribavirin: tablets given bid for up to 48 weeks
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.0 years
STANDARD_DEVIATION 15.56 • n=5 Participants
|
44.6 years
STANDARD_DEVIATION 8.67 • n=7 Participants
|
45.1 years
STANDARD_DEVIATION 9.29 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 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
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
4 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Region of Enrollment
Puerto Rico
|
1 participants
n=5 Participants
|
4 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
IL28B genotype
IL28B_CT
|
2 participants
n=5 Participants
|
6 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
IL28B genotype
IL28B_TT
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
HCV genotype
HCV_1a
|
1 participants
n=5 Participants
|
7 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
HCV genotype
HCV_1b
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
HCV RNA
|
7.21 log10 IU/mL
STANDARD_DEVIATION 0.05 • n=5 Participants
|
6.3 log10 IU/mL
STANDARD_DEVIATION 0.49 • n=7 Participants
|
6.48 log10 IU/mL
STANDARD_DEVIATION 0.58 • n=5 Participants
|
PRIMARY outcome
Timeframe: Week 4Outcome measures
| Measure |
Placebo
n=2 Participants
Placebo + PegIFN + RBV for 4 weeks followed by PegIFN + RBV for 20 weeks
Placebo: Oral tablets given bid for 28 days
peginterferon alfa 2a: 180 ug prefilled syringe given once per week for up to 48 weeks
Ribavirin: tablets given bid for up to 48 weeks
|
SCY-635 600 mg
n=8 Participants
SCY-635 600 mg + PegIFN + RBV for 4 weeks followed by PegIFN + RBV for 20 weeks
SCY-635: SCY-635 tablets, 300 mg bid for 28 days
peginterferon alfa 2a: 180 ug prefilled syringe given once per week for up to 48 weeks
Ribavirin: tablets given bid for up to 48 weeks
|
|---|---|---|
|
Undetectable HCV RNA
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Week 12Outcome measures
| Measure |
Placebo
n=2 Participants
Placebo + PegIFN + RBV for 4 weeks followed by PegIFN + RBV for 20 weeks
Placebo: Oral tablets given bid for 28 days
peginterferon alfa 2a: 180 ug prefilled syringe given once per week for up to 48 weeks
Ribavirin: tablets given bid for up to 48 weeks
|
SCY-635 600 mg
n=8 Participants
SCY-635 600 mg + PegIFN + RBV for 4 weeks followed by PegIFN + RBV for 20 weeks
SCY-635: SCY-635 tablets, 300 mg bid for 28 days
peginterferon alfa 2a: 180 ug prefilled syringe given once per week for up to 48 weeks
Ribavirin: tablets given bid for up to 48 weeks
|
|---|---|---|
|
Undetectable HCV RNA
|
0 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Week 12Proportion of subjects with detectable HCV RNA that achieve a \> or = 2 log reduction in HCV RNA from baseline to Week 12
Outcome measures
| Measure |
Placebo
n=2 Participants
Placebo + PegIFN + RBV for 4 weeks followed by PegIFN + RBV for 20 weeks
Placebo: Oral tablets given bid for 28 days
peginterferon alfa 2a: 180 ug prefilled syringe given once per week for up to 48 weeks
Ribavirin: tablets given bid for up to 48 weeks
|
SCY-635 600 mg
n=8 Participants
SCY-635 600 mg + PegIFN + RBV for 4 weeks followed by PegIFN + RBV for 20 weeks
SCY-635: SCY-635 tablets, 300 mg bid for 28 days
peginterferon alfa 2a: 180 ug prefilled syringe given once per week for up to 48 weeks
Ribavirin: tablets given bid for up to 48 weeks
|
|---|---|---|
|
Partial Early Virologic Response
|
0 participants
|
4 participants
|
SECONDARY outcome
Timeframe: Week 24Population: Week 24 analysis does not include the 2 placebo subjects because they were discontinued for lack of efficacy before week 24.
Outcome measures
| Measure |
Placebo
Placebo + PegIFN + RBV for 4 weeks followed by PegIFN + RBV for 20 weeks
Placebo: Oral tablets given bid for 28 days
peginterferon alfa 2a: 180 ug prefilled syringe given once per week for up to 48 weeks
Ribavirin: tablets given bid for up to 48 weeks
|
SCY-635 600 mg
n=8 Participants
SCY-635 600 mg + PegIFN + RBV for 4 weeks followed by PegIFN + RBV for 20 weeks
SCY-635: SCY-635 tablets, 300 mg bid for 28 days
peginterferon alfa 2a: 180 ug prefilled syringe given once per week for up to 48 weeks
Ribavirin: tablets given bid for up to 48 weeks
|
|---|---|---|
|
Undetectable HCV RNA
|
—
|
5 participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
SCY-635 600 mg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=2 participants at risk
Placebo + PegIFN + RBV for 4 weeks followed by PegIFN + RBV for 20 weeks
Placebo: Oral tablets given bid for 28 days
peginterferon alfa 2a: 180 ug prefilled syringe given once per week for up to 48 weeks
Ribavirin: tablets given bid for up to 48 weeks
|
SCY-635 600 mg
n=8 participants at risk
SCY-635 600 mg + PegIFN + RBV for 4 weeks followed by PegIFN + RBV for 20 weeks
SCY-635: SCY-635 tablets, 300 mg bid for 28 days
peginterferon alfa 2a: 180 ug prefilled syringe given once per week for up to 48 weeks
Ribavirin: tablets given bid for up to 48 weeks
|
|---|---|---|
|
Blood and lymphatic system disorders
neutropenia
|
0.00%
0/2 • 24 weeks
|
37.5%
3/8 • 24 weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
50.0%
1/2 • 24 weeks
|
25.0%
2/8 • 24 weeks
|
|
General disorders
Fatigue
|
50.0%
1/2 • 24 weeks
|
25.0%
2/8 • 24 weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/2 • 24 weeks
|
37.5%
3/8 • 24 weeks
|
|
Psychiatric disorders
Insomnia
|
50.0%
1/2 • 24 weeks
|
12.5%
1/8 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/2 • 24 weeks
|
25.0%
2/8 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/2 • 24 weeks
|
25.0%
2/8 • 24 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place