Trial Outcomes & Findings for A Study of TMC435 in Combination With PSI-7977 (GS7977) in Chronic Hepatitis C Genotype 1-Infected Prior Null Responders To Peginterferon/Ribavirin Therapy or HCV Treatment-Naive Patients (NCT NCT01466790)
NCT ID: NCT01466790
Last Updated: 2015-02-09
Results Overview
Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) undetectable at end of treatment and HCV RNA less than (\<) 25 international unit per milliliter (IU/mL) (detectable or undetectable) at 12 weeks after the planned end of treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
168 participants
Primary outcome timeframe
Week 12 and 24 (for the arms treated for 12 weeks) or Week 24 and 36 (for the arms treated for 24 weeks)
Results posted on
2015-02-09
Participant Flow
A total of 168 participants enrolled to study. 1 participant who was randomized to Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks group, but never received treatment.
Participant milestones
| Measure |
Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks
Cohort 1 participants (without advanced hepatic fibrosis, who did not respond to previous pegylated interferon \[PegIFN\]/ribavirin therapy) received TMC435 150 milligram (mg) capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kilogram \[kg\] and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
|
Cohort 1: TMC435 and PSI-7977 for 24 Weeks
Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
|
Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks
Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
|
Cohort 1: TMC435 and PSI-7977 for 12 Weeks
Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
|
Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks
Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
|
Cohort 2: TMC435 and PSI-7977 for 24 Weeks
Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
|
Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks
Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
|
Cohort 2: TMC435 and PSI-7977 for 12 Weeks
Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
24
|
15
|
27
|
14
|
30
|
16
|
27
|
14
|
|
Overall Study
COMPLETED
|
20
|
14
|
27
|
14
|
27
|
16
|
26
|
13
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
0
|
0
|
3
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks
Cohort 1 participants (without advanced hepatic fibrosis, who did not respond to previous pegylated interferon \[PegIFN\]/ribavirin therapy) received TMC435 150 milligram (mg) capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kilogram \[kg\] and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
|
Cohort 1: TMC435 and PSI-7977 for 24 Weeks
Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
|
Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks
Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
|
Cohort 1: TMC435 and PSI-7977 for 12 Weeks
Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
|
Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks
Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
|
Cohort 2: TMC435 and PSI-7977 for 24 Weeks
Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
|
Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks
Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
|
Cohort 2: TMC435 and PSI-7977 for 12 Weeks
Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
0
|
1
|
0
|
1
|
1
|
Baseline Characteristics
A Study of TMC435 in Combination With PSI-7977 (GS7977) in Chronic Hepatitis C Genotype 1-Infected Prior Null Responders To Peginterferon/Ribavirin Therapy or HCV Treatment-Naive Patients
Baseline characteristics by cohort
| Measure |
Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks
n=24 Participants
Cohort 1 participants (without advanced hepatic fibrosis, who did not respond to previous pegylated interferon \[PegIFN\]/ribavirin therapy) received TMC435 150 milligram (mg) capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kilogram \[kg\] and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
|
Cohort 1: TMC435 and PSI-7977 for 24 Weeks
n=15 Participants
Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
|
Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks
n=27 Participants
Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
|
Cohort 1: TMC435 and PSI-7977 for 12 Weeks
n=14 Participants
Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
|
Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks
n=30 Participants
Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
|
Cohort 2: TMC435 and PSI-7977 for 24 Weeks
n=16 Participants
Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
|
Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks
n=27 Participants
Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
|
Cohort 2: TMC435 and PSI-7977 for 12 Weeks
n=14 Participants
Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
|
Total
n=167 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
56 years
n=5 Participants
|
56 years
n=7 Participants
|
55 years
n=5 Participants
|
55.5 years
n=4 Participants
|
58 years
n=21 Participants
|
57.5 years
n=8 Participants
|
57 years
n=8 Participants
|
57.5 years
n=24 Participants
|
57 years
n=42 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
60 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
20 Participants
n=8 Participants
|
10 Participants
n=24 Participants
|
107 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Week 12 and 24 (for the arms treated for 12 weeks) or Week 24 and 36 (for the arms treated for 24 weeks)Population: Intention-to-treat (ITT) population included all randomized participants who took at least one dose of investigational drug.
Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) undetectable at end of treatment and HCV RNA less than (\<) 25 international unit per milliliter (IU/mL) (detectable or undetectable) at 12 weeks after the planned end of treatment.
Outcome measures
| Measure |
Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks
n=24 Participants
Cohort 1 participants (without advanced hepatic fibrosis, who did not respond to previous pegylated interferon \[PegIFN\]/ribavirin therapy) received TMC435 150 milligram (mg) capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kilogram \[kg\] and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
|
Cohort 1: TMC435 and PSI-7977 for 24 Weeks
n=15 Participants
Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
|
Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks
n=27 Participants
Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
|
Cohort 1: TMC435 and PSI-7977 for 12 Weeks
n=14 Participants
Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
|
Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks
n=30 Participants
Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
|
Cohort 2: TMC435 and PSI-7977 for 24 Weeks
n=16 Participants
Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
|
Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks
n=27 Participants
Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
|
Cohort 2: TMC435 and PSI-7977 for 12 Weeks
n=14 Participants
Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With a Sustained Virologic Response (SVR) 12 Weeks After the Planned End of Treatment (EOT)
|
19 Participants
|
14 Participants
|
26 Participants
|
13 Participants
|
28 Participants
|
16 Participants
|
25 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Week 12 and 16 (for the arms treated for 12 weeks) or Week 24 and 28 (for the arms treated for 24 weeks)Population: Intention-to-treat (ITT) population included all randomized participants who took at least one dose of investigational drug.
Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) undetectable at end of treatment and HCV RNA less than (\<) 25 international unit per milliliter (IU/mL) (detectable or undetectable) at 4 weeks after the planned end of treatment.
Outcome measures
| Measure |
Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks
n=24 Participants
Cohort 1 participants (without advanced hepatic fibrosis, who did not respond to previous pegylated interferon \[PegIFN\]/ribavirin therapy) received TMC435 150 milligram (mg) capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kilogram \[kg\] and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
|
Cohort 1: TMC435 and PSI-7977 for 24 Weeks
n=15 Participants
Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
|
Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks
n=27 Participants
Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
|
Cohort 1: TMC435 and PSI-7977 for 12 Weeks
n=14 Participants
Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
|
Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks
n=30 Participants
Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
|
Cohort 2: TMC435 and PSI-7977 for 24 Weeks
n=16 Participants
Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
|
Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks
n=27 Participants
Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
|
Cohort 2: TMC435 and PSI-7977 for 12 Weeks
n=14 Participants
Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With a Sustained Virologic Response (SVR) 4 Weeks After the Planned End of Treatment (EOT)
|
20 Participants
|
14 Participants
|
26 Participants
|
13 Participants
|
28 Participants
|
16 Participants
|
26 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Week 12 and 36 (for the arms treated for 12 weeks) or Week 24 and 48 (for the arms treated for 24 weeks)Population: Intention-to-treat (ITT) population included all randomized participants who took at least one dose of investigational drug.
Participants with HCV RNA undetectable at end of treatment and HCV RNA less than (\<) 25 IU/mL (detectable or undetectable) at 24 weeks after the planned end of treatment.
Outcome measures
| Measure |
Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks
n=24 Participants
Cohort 1 participants (without advanced hepatic fibrosis, who did not respond to previous pegylated interferon \[PegIFN\]/ribavirin therapy) received TMC435 150 milligram (mg) capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kilogram \[kg\] and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
|
Cohort 1: TMC435 and PSI-7977 for 24 Weeks
n=15 Participants
Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
|
Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks
n=27 Participants
Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
|
Cohort 1: TMC435 and PSI-7977 for 12 Weeks
n=14 Participants
Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
|
Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks
n=30 Participants
Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
|
Cohort 2: TMC435 and PSI-7977 for 24 Weeks
n=16 Participants
Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
|
Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks
n=27 Participants
Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
|
Cohort 2: TMC435 and PSI-7977 for 12 Weeks
n=14 Participants
Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With a Sustained Virologic Response (SVR) 24 Weeks After the Planned End of Treatment (EOT)
|
19 Participants
|
14 Participants
|
26 Participants
|
13 Participants
|
28 Participants
|
16 Participants
|
25 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Week 48Population: Intention-to-treat (ITT) population included all randomized participants who took at least one dose of investigational drug.
Participants with HCV RNA undetectable at end of treatment and HCV RNA less than (\<) 25 IU/mL (detectable or undetectable) at week 48.
Outcome measures
| Measure |
Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks
n=24 Participants
Cohort 1 participants (without advanced hepatic fibrosis, who did not respond to previous pegylated interferon \[PegIFN\]/ribavirin therapy) received TMC435 150 milligram (mg) capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kilogram \[kg\] and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
|
Cohort 1: TMC435 and PSI-7977 for 24 Weeks
n=15 Participants
Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
|
Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks
n=27 Participants
Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
|
Cohort 1: TMC435 and PSI-7977 for 12 Weeks
n=14 Participants
Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
|
Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks
n=30 Participants
Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
|
Cohort 2: TMC435 and PSI-7977 for 24 Weeks
n=16 Participants
Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
|
Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks
n=27 Participants
Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
|
Cohort 2: TMC435 and PSI-7977 for 12 Weeks
n=14 Participants
Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With a Sustained Virologic Response (SVR) at Week 48
|
19 Participants
|
14 Participants
|
26 Participants
|
13 Participants
|
27 Participants
|
16 Participants
|
24 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Up to End of Treatment [Week 12 (for the arms treated for 12 weeks) or Week 24 (for the arms treated for 24 weeks)]Population: Intention-to-treat (ITT) population included all randomized participants who took at least one dose of investigational drug.
Viral breakthrough was defined as confirmed quantifiable HCV RNA after becoming less than (\<) lower limit of quantification (LLOQ) or confirmed greater than (\>) 1 log10 HCV RNA increase from the lowest level reached on 2 consecutive occasions.
Outcome measures
| Measure |
Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks
n=24 Participants
Cohort 1 participants (without advanced hepatic fibrosis, who did not respond to previous pegylated interferon \[PegIFN\]/ribavirin therapy) received TMC435 150 milligram (mg) capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kilogram \[kg\] and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
|
Cohort 1: TMC435 and PSI-7977 for 24 Weeks
n=15 Participants
Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
|
Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks
n=27 Participants
Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
|
Cohort 1: TMC435 and PSI-7977 for 12 Weeks
n=14 Participants
Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
|
Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks
n=30 Participants
Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
|
Cohort 2: TMC435 and PSI-7977 for 24 Weeks
n=16 Participants
Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
|
Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks
n=27 Participants
Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
|
Cohort 2: TMC435 and PSI-7977 for 12 Weeks
n=14 Participants
Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Viral Breakthrough
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 8 and End of Treatment [Week 12 (for the arms treated for 12 weeks) or Week 24 (for the arms treated for 24 weeks)]Population: Intention-to-treat (ITT) population included all randomized participants who took at least one dose of investigational drug.
Inadequate Virologic Response was defined as confirmed detectable HCV RNA at or after Week 8 and not meeting the viral breakthrough definition.
Outcome measures
| Measure |
Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks
n=24 Participants
Cohort 1 participants (without advanced hepatic fibrosis, who did not respond to previous pegylated interferon \[PegIFN\]/ribavirin therapy) received TMC435 150 milligram (mg) capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kilogram \[kg\] and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
|
Cohort 1: TMC435 and PSI-7977 for 24 Weeks
n=15 Participants
Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
|
Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks
n=27 Participants
Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
|
Cohort 1: TMC435 and PSI-7977 for 12 Weeks
n=14 Participants
Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
|
Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks
n=30 Participants
Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
|
Cohort 2: TMC435 and PSI-7977 for 24 Weeks
n=16 Participants
Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
|
Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks
n=27 Participants
Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
|
Cohort 2: TMC435 and PSI-7977 for 12 Weeks
n=14 Participants
Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Inadequate Virologic Response
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During the Follow-up [Week 36 (for the arms treated for 12 weeks) or Week 24 (for the arms treated for 24 weeks)]Population: Intention-to-treat (ITT) population included all randomized participants who took at least one dose of investigational drug.
Viral relapse was defined as undetectable HCV RNA at the actual EOT and confirmed quantifiable HCV RNA (\>= 25 IU/mL) during follow-up period.
Outcome measures
| Measure |
Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks
n=24 Participants
Cohort 1 participants (without advanced hepatic fibrosis, who did not respond to previous pegylated interferon \[PegIFN\]/ribavirin therapy) received TMC435 150 milligram (mg) capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kilogram \[kg\] and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
|
Cohort 1: TMC435 and PSI-7977 for 24 Weeks
n=15 Participants
Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
|
Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks
n=27 Participants
Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
|
Cohort 1: TMC435 and PSI-7977 for 12 Weeks
n=14 Participants
Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
|
Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks
n=30 Participants
Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
|
Cohort 2: TMC435 and PSI-7977 for 24 Weeks
n=16 Participants
Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
|
Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks
n=27 Participants
Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
|
Cohort 2: TMC435 and PSI-7977 for 12 Weeks
n=14 Participants
Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Viral Relapse
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
Adverse Events
Cohort 1 and 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks
Serious events: 3 serious events
Other events: 48 other events
Deaths: 0 deaths
Cohort 1 and 2: TMC435 and PSI-7977 for 24 Weeks
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
Cohort 1 and 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks
Serious events: 0 serious events
Other events: 42 other events
Deaths: 0 deaths
Cohort 1 and 2: TMC435 and PSI-7977 for 12 Weeks
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1 and 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks
n=54 participants at risk
Cohorts 1 and 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
|
Cohort 1 and 2: TMC435 and PSI-7977 for 24 Weeks
n=31 participants at risk
Cohorts 1 and 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
|
Cohort 1 and 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks
n=54 participants at risk
Cohorts 1 and 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
|
Cohort 1 and 2: TMC435 and PSI-7977 for 12 Weeks
n=28 participants at risk
Cohorts 1 and 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/54 • Up to Week 48
|
3.2%
1/31 • Up to Week 48
|
0.00%
0/54 • Up to Week 48
|
0.00%
0/28 • Up to Week 48
|
|
Eye disorders
Retinal tear
|
1.9%
1/54 • Up to Week 48
|
0.00%
0/31 • Up to Week 48
|
0.00%
0/54 • Up to Week 48
|
0.00%
0/28 • Up to Week 48
|
|
Eye disorders
Visual impairment
|
1.9%
1/54 • Up to Week 48
|
0.00%
0/31 • Up to Week 48
|
0.00%
0/54 • Up to Week 48
|
0.00%
0/28 • Up to Week 48
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.9%
1/54 • Up to Week 48
|
0.00%
0/31 • Up to Week 48
|
0.00%
0/54 • Up to Week 48
|
0.00%
0/28 • Up to Week 48
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
1.9%
1/54 • Up to Week 48
|
0.00%
0/31 • Up to Week 48
|
0.00%
0/54 • Up to Week 48
|
0.00%
0/28 • Up to Week 48
|
Other adverse events
| Measure |
Cohort 1 and 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks
n=54 participants at risk
Cohorts 1 and 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
|
Cohort 1 and 2: TMC435 and PSI-7977 for 24 Weeks
n=31 participants at risk
Cohorts 1 and 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
|
Cohort 1 and 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks
n=54 participants at risk
Cohorts 1 and 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
|
Cohort 1 and 2: TMC435 and PSI-7977 for 12 Weeks
n=28 participants at risk
Cohorts 1 and 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
24.1%
13/54 • Up to Week 48
|
0.00%
0/31 • Up to Week 48
|
11.1%
6/54 • Up to Week 48
|
0.00%
0/28 • Up to Week 48
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/54 • Up to Week 48
|
6.5%
2/31 • Up to Week 48
|
0.00%
0/54 • Up to Week 48
|
0.00%
0/28 • Up to Week 48
|
|
Gastrointestinal disorders
Abdominal pain
|
3.7%
2/54 • Up to Week 48
|
9.7%
3/31 • Up to Week 48
|
0.00%
0/54 • Up to Week 48
|
0.00%
0/28 • Up to Week 48
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.3%
5/54 • Up to Week 48
|
0.00%
0/31 • Up to Week 48
|
3.7%
2/54 • Up to Week 48
|
0.00%
0/28 • Up to Week 48
|
|
Gastrointestinal disorders
Constipation
|
7.4%
4/54 • Up to Week 48
|
3.2%
1/31 • Up to Week 48
|
7.4%
4/54 • Up to Week 48
|
3.6%
1/28 • Up to Week 48
|
|
Gastrointestinal disorders
Diarrhoea
|
1.9%
1/54 • Up to Week 48
|
16.1%
5/31 • Up to Week 48
|
5.6%
3/54 • Up to Week 48
|
7.1%
2/28 • Up to Week 48
|
|
Gastrointestinal disorders
Dry mouth
|
5.6%
3/54 • Up to Week 48
|
0.00%
0/31 • Up to Week 48
|
3.7%
2/54 • Up to Week 48
|
0.00%
0/28 • Up to Week 48
|
|
Gastrointestinal disorders
Dyspepsia
|
5.6%
3/54 • Up to Week 48
|
3.2%
1/31 • Up to Week 48
|
3.7%
2/54 • Up to Week 48
|
0.00%
0/28 • Up to Week 48
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
9.3%
5/54 • Up to Week 48
|
0.00%
0/31 • Up to Week 48
|
0.00%
0/54 • Up to Week 48
|
7.1%
2/28 • Up to Week 48
|
|
Gastrointestinal disorders
Nausea
|
13.0%
7/54 • Up to Week 48
|
12.9%
4/31 • Up to Week 48
|
16.7%
9/54 • Up to Week 48
|
21.4%
6/28 • Up to Week 48
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/54 • Up to Week 48
|
6.5%
2/31 • Up to Week 48
|
1.9%
1/54 • Up to Week 48
|
0.00%
0/28 • Up to Week 48
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
3/54 • Up to Week 48
|
3.2%
1/31 • Up to Week 48
|
1.9%
1/54 • Up to Week 48
|
0.00%
0/28 • Up to Week 48
|
|
General disorders
Chills
|
5.6%
3/54 • Up to Week 48
|
0.00%
0/31 • Up to Week 48
|
1.9%
1/54 • Up to Week 48
|
0.00%
0/28 • Up to Week 48
|
|
General disorders
Fatigue
|
38.9%
21/54 • Up to Week 48
|
32.3%
10/31 • Up to Week 48
|
25.9%
14/54 • Up to Week 48
|
25.0%
7/28 • Up to Week 48
|
|
General disorders
Influenza like illness
|
1.9%
1/54 • Up to Week 48
|
6.5%
2/31 • Up to Week 48
|
0.00%
0/54 • Up to Week 48
|
0.00%
0/28 • Up to Week 48
|
|
General disorders
Oedema peripheral
|
7.4%
4/54 • Up to Week 48
|
0.00%
0/31 • Up to Week 48
|
0.00%
0/54 • Up to Week 48
|
0.00%
0/28 • Up to Week 48
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
3.7%
2/54 • Up to Week 48
|
3.2%
1/31 • Up to Week 48
|
7.4%
4/54 • Up to Week 48
|
0.00%
0/28 • Up to Week 48
|
|
Immune system disorders
Seasonal allergy
|
5.6%
3/54 • Up to Week 48
|
0.00%
0/31 • Up to Week 48
|
0.00%
0/54 • Up to Week 48
|
3.6%
1/28 • Up to Week 48
|
|
Infections and infestations
Bronchitis
|
3.7%
2/54 • Up to Week 48
|
6.5%
2/31 • Up to Week 48
|
0.00%
0/54 • Up to Week 48
|
0.00%
0/28 • Up to Week 48
|
|
Infections and infestations
Oral herpes
|
7.4%
4/54 • Up to Week 48
|
0.00%
0/31 • Up to Week 48
|
0.00%
0/54 • Up to Week 48
|
0.00%
0/28 • Up to Week 48
|
|
Infections and infestations
Sinusitis
|
1.9%
1/54 • Up to Week 48
|
6.5%
2/31 • Up to Week 48
|
5.6%
3/54 • Up to Week 48
|
0.00%
0/28 • Up to Week 48
|
|
Infections and infestations
Upper respiratory tract infection
|
5.6%
3/54 • Up to Week 48
|
6.5%
2/31 • Up to Week 48
|
11.1%
6/54 • Up to Week 48
|
3.6%
1/28 • Up to Week 48
|
|
Infections and infestations
Urinary tract infection
|
5.6%
3/54 • Up to Week 48
|
6.5%
2/31 • Up to Week 48
|
1.9%
1/54 • Up to Week 48
|
0.00%
0/28 • Up to Week 48
|
|
Injury, poisoning and procedural complications
Sunburn
|
1.9%
1/54 • Up to Week 48
|
0.00%
0/31 • Up to Week 48
|
3.7%
2/54 • Up to Week 48
|
7.1%
2/28 • Up to Week 48
|
|
Investigations
Blood amylase increased
|
3.7%
2/54 • Up to Week 48
|
6.5%
2/31 • Up to Week 48
|
7.4%
4/54 • Up to Week 48
|
0.00%
0/28 • Up to Week 48
|
|
Investigations
Blood creatine phosphokinase increased
|
7.4%
4/54 • Up to Week 48
|
6.5%
2/31 • Up to Week 48
|
11.1%
6/54 • Up to Week 48
|
3.6%
1/28 • Up to Week 48
|
|
Investigations
Lipase increased
|
3.7%
2/54 • Up to Week 48
|
3.2%
1/31 • Up to Week 48
|
5.6%
3/54 • Up to Week 48
|
0.00%
0/28 • Up to Week 48
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.9%
1/54 • Up to Week 48
|
3.2%
1/31 • Up to Week 48
|
3.7%
2/54 • Up to Week 48
|
7.1%
2/28 • Up to Week 48
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.7%
2/54 • Up to Week 48
|
3.2%
1/31 • Up to Week 48
|
1.9%
1/54 • Up to Week 48
|
7.1%
2/28 • Up to Week 48
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.6%
3/54 • Up to Week 48
|
9.7%
3/31 • Up to Week 48
|
5.6%
3/54 • Up to Week 48
|
3.6%
1/28 • Up to Week 48
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.6%
3/54 • Up to Week 48
|
0.00%
0/31 • Up to Week 48
|
3.7%
2/54 • Up to Week 48
|
3.6%
1/28 • Up to Week 48
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.4%
4/54 • Up to Week 48
|
6.5%
2/31 • Up to Week 48
|
3.7%
2/54 • Up to Week 48
|
0.00%
0/28 • Up to Week 48
|
|
Nervous system disorders
Dizziness
|
13.0%
7/54 • Up to Week 48
|
16.1%
5/31 • Up to Week 48
|
5.6%
3/54 • Up to Week 48
|
3.6%
1/28 • Up to Week 48
|
|
Nervous system disorders
Headache
|
20.4%
11/54 • Up to Week 48
|
22.6%
7/31 • Up to Week 48
|
16.7%
9/54 • Up to Week 48
|
21.4%
6/28 • Up to Week 48
|
|
Nervous system disorders
Memory impairment
|
1.9%
1/54 • Up to Week 48
|
6.5%
2/31 • Up to Week 48
|
1.9%
1/54 • Up to Week 48
|
0.00%
0/28 • Up to Week 48
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/54 • Up to Week 48
|
0.00%
0/31 • Up to Week 48
|
5.6%
3/54 • Up to Week 48
|
3.6%
1/28 • Up to Week 48
|
|
Psychiatric disorders
Insomnia
|
16.7%
9/54 • Up to Week 48
|
6.5%
2/31 • Up to Week 48
|
9.3%
5/54 • Up to Week 48
|
14.3%
4/28 • Up to Week 48
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.8%
8/54 • Up to Week 48
|
6.5%
2/31 • Up to Week 48
|
5.6%
3/54 • Up to Week 48
|
3.6%
1/28 • Up to Week 48
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
5.6%
3/54 • Up to Week 48
|
0.00%
0/31 • Up to Week 48
|
5.6%
3/54 • Up to Week 48
|
0.00%
0/28 • Up to Week 48
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/54 • Up to Week 48
|
6.5%
2/31 • Up to Week 48
|
3.7%
2/54 • Up to Week 48
|
3.6%
1/28 • Up to Week 48
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.9%
1/54 • Up to Week 48
|
9.7%
3/31 • Up to Week 48
|
5.6%
3/54 • Up to Week 48
|
3.6%
1/28 • Up to Week 48
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
1.9%
1/54 • Up to Week 48
|
0.00%
0/31 • Up to Week 48
|
5.6%
3/54 • Up to Week 48
|
0.00%
0/28 • Up to Week 48
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.4%
4/54 • Up to Week 48
|
3.2%
1/31 • Up to Week 48
|
3.7%
2/54 • Up to Week 48
|
7.1%
2/28 • Up to Week 48
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
1.9%
1/54 • Up to Week 48
|
6.5%
2/31 • Up to Week 48
|
1.9%
1/54 • Up to Week 48
|
0.00%
0/28 • Up to Week 48
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
9/54 • Up to Week 48
|
3.2%
1/31 • Up to Week 48
|
9.3%
5/54 • Up to Week 48
|
10.7%
3/28 • Up to Week 48
|
|
Skin and subcutaneous tissue disorders
Rash
|
13.0%
7/54 • Up to Week 48
|
9.7%
3/31 • Up to Week 48
|
14.8%
8/54 • Up to Week 48
|
3.6%
1/28 • Up to Week 48
|
|
Vascular disorders
Hypertension
|
3.7%
2/54 • Up to Week 48
|
6.5%
2/31 • Up to Week 48
|
9.3%
5/54 • Up to Week 48
|
0.00%
0/28 • Up to Week 48
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60