Trial Outcomes & Findings for Treatment of Chronic Delta Hepatitis With Lonafarnib and Ritonavir (NCT NCT02511431)
NCT ID: NCT02511431
Last Updated: 2018-09-25
Results Overview
The number of participants who experienced a \> 2 log IU/mL decline in serum HDV RNA at 12 weeks of treatment
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
22 participants
Primary outcome timeframe
12 weeks
Results posted on
2018-09-25
Participant Flow
Enrollment number in the Protocol Section (22) conflicts with the number of participants started (21). One enrolled patient declined participation prior to randomization.
Participant milestones
| Measure |
50mg/100mg Lonafarnib/Ritonavir
Lonafarnib/Ritonavir at 50 mg/100 mg daily for 24 weeks followed by 24 weeks of off therapy follow-up.
Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.
Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same cytochrome p450 (CYP) system. Will be administered at 100 mg daily.
|
75mg/100mg Lonafarnib/Ritonavir
Lonafarnib/Ritonavir at 75 mg/100 mg daily for 24 weeks followed by 24 weeks of off therapy follow-up.
Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.
Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily.
|
100mg/100mg Lonafarnib/Ritonavir
Lonafarnib/Ritonavir at 100 mg/100 mg daily for 24 weeks followed by 24 weeks of off therapy follow-up.
Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.
Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily.
|
Placebo Then 50 mg/100 mg Lonafarnib/Ritonavir
Placebo for 12 weeks then Lonafarnib/Ritonavir at 50 mg/100 mg daily for 12 weeks followed by 24 weeks of off therapy follow-up.
Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.
Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily.
Placebo: Placebo
|
Placebo Then 75mg/100mg Lonafarnib/Ritonavir
Placebo for 12 weeks then Lonafarnib/Ritonavir at 75 mg/100 mg daily for 12 weeks followed by 24 weeks of off therapy follow-up.
Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.
Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily.
Placebo: Placebo
|
Placebo Then 100mg/100mg Lonafarnib/Ritonavir
Placebo for 12 weeks then Lonafarnib/Ritonavir at 100 mg/100 mg daily for 12 weeks followed by 24 weeks of off therapy follow-up.
Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.
Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily.
Placebo: Placebo
|
|---|---|---|---|---|---|---|
|
Treatment
STARTED
|
4
|
4
|
4
|
3
|
3
|
3
|
|
Treatment
COMPLETED
|
4
|
4
|
3
|
3
|
3
|
2
|
|
Treatment
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
1
|
|
Post-treatment Follow-up
STARTED
|
4
|
4
|
3
|
3
|
3
|
2
|
|
Post-treatment Follow-up
COMPLETED
|
4
|
4
|
3
|
3
|
3
|
2
|
|
Post-treatment Follow-up
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
50mg/100mg Lonafarnib/Ritonavir
Lonafarnib/Ritonavir at 50 mg/100 mg daily for 24 weeks followed by 24 weeks of off therapy follow-up.
Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.
Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same cytochrome p450 (CYP) system. Will be administered at 100 mg daily.
|
75mg/100mg Lonafarnib/Ritonavir
Lonafarnib/Ritonavir at 75 mg/100 mg daily for 24 weeks followed by 24 weeks of off therapy follow-up.
Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.
Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily.
|
100mg/100mg Lonafarnib/Ritonavir
Lonafarnib/Ritonavir at 100 mg/100 mg daily for 24 weeks followed by 24 weeks of off therapy follow-up.
Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.
Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily.
|
Placebo Then 50 mg/100 mg Lonafarnib/Ritonavir
Placebo for 12 weeks then Lonafarnib/Ritonavir at 50 mg/100 mg daily for 12 weeks followed by 24 weeks of off therapy follow-up.
Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.
Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily.
Placebo: Placebo
|
Placebo Then 75mg/100mg Lonafarnib/Ritonavir
Placebo for 12 weeks then Lonafarnib/Ritonavir at 75 mg/100 mg daily for 12 weeks followed by 24 weeks of off therapy follow-up.
Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.
Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily.
Placebo: Placebo
|
Placebo Then 100mg/100mg Lonafarnib/Ritonavir
Placebo for 12 weeks then Lonafarnib/Ritonavir at 100 mg/100 mg daily for 12 weeks followed by 24 weeks of off therapy follow-up.
Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.
Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily.
Placebo: Placebo
|
|---|---|---|---|---|---|---|
|
Treatment
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
1
|
Baseline Characteristics
Treatment of Chronic Delta Hepatitis With Lonafarnib and Ritonavir
Baseline characteristics by cohort
| Measure |
50mg/100mg Lonafarnib/Ritonavir
n=4 Participants
Lonafarnib/Ritonavir at 50 mg/100 mg daily for 24 weeks followed by 24 weeks of off therapy follow-up.
Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.
Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily.
|
75mg/100mg Lonafarnib/Ritonavir
n=4 Participants
Lonafarnib/Ritonavir at 75 mg/100 mg daily for 24 weeks followed by 24 weeks of off therapy follow-up.
Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.
Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily.
|
100mg/100mg Lonafarnib/Ritonavir
n=4 Participants
Lonafarnib/Ritonavir at 100 mg/100 mg daily for 24 weeks followed by 24 weeks of off therapy follow-up.
Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.
Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily.
|
Placebo Then 50 mg/100 mg Lonafarnib/Ritonavir
n=3 Participants
Placebo for 12 weeks then Lonafarnib/Ritonavir at 50 mg/100 mg daily for 12 weeks followed by 24 weeks of off therapy follow-up.
Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.
Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily.
Placebo: Placebo
|
Placebo Then 75mg/100mg Lonafarnib/Ritonavir
n=3 Participants
Placebo for 12 weeks then Lonafarnib/Ritonavir at 75 mg/100 mg daily for 12 weeks followed by 24 weeks of off therapy follow-up.
Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.
Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily.
Placebo: Placebo
|
Placebo Then 100mg/100mg Lonafarnib/Ritonavir
n=3 Participants
Placebo for 12 weeks then Lonafarnib/Ritonavir at 100 mg/100 mg daily for 12 weeks followed by 24 weeks of off therapy follow-up.
Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.
Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily.
Placebo: Placebo
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
48 years
n=5 Participants
|
43.5 years
n=7 Participants
|
40.5 years
n=5 Participants
|
39 years
n=4 Participants
|
52 years
n=21 Participants
|
45 years
n=8 Participants
|
45 years
n=8 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
13 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 12 weeksThe number of participants who experienced a \> 2 log IU/mL decline in serum HDV RNA at 12 weeks of treatment
Outcome measures
| Measure |
50mg/100mg Lonafarnib/Ritonavir
n=4 Participants
Lonafarnib/Ritonavir at 50 mg/100 mg daily for 24 weeks followed by 24 weeks of off therapy follow-up.
Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.
Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily.
|
75mg/100mg Lonafarnib/Ritonavir
n=4 Participants
Lonafarnib/Ritonavir at 75 mg/100 mg daily for 24 weeks followed by 24 weeks of off therapy follow-up.
Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.
Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily.
|
100mg/100mg Lonafarnib/Ritonavir
n=4 Participants
Lonafarnib/Ritonavir at 100 mg/100 mg daily for 24 weeks followed by 24 weeks of off therapy follow-up.
Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.
Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily.
|
Placebo Then 50 mg/100 mg Lonafarnib/Ritonavir
n=3 Participants
Placebo for 12 weeks then Lonafarnib/Ritonavir at 50 mg/100 mg daily for 12 weeks followed by 24 weeks of off therapy follow-up.
Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.
Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily.
Placebo: Placebo
|
Placebo Then 75mg/100mg Lonafarnib/Ritonavir
n=3 Participants
Placebo for 12 weeks then Lonafarnib/Ritonavir at 75 mg/100 mg daily for 12 weeks followed by 24 weeks of off therapy follow-up.
Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.
Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily.
Placebo: Placebo
|
Placebo Then 100mg/100mg Lonafarnib/Ritonavir
n=2 Participants
Placebo for 12 weeks then Lonafarnib/Ritonavir at 100 mg/100 mg daily for 12 weeks followed by 24 weeks of off therapy follow-up.
Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.
Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily.
Placebo: Placebo
|
|---|---|---|---|---|---|---|
|
Number of Participants With Decline of Hepatitis Delta Virus (HDV) RNA Quantitative Measurements of >2 Logs From Baseline at 12 Weeks of Treatment
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: This outcome is for decline in serum HDV RNA levels over 24 weeks of treatment. Arms 4, 5 and 6 had only 12 weeks of treatment and so are not included in this analysis.
The number of participants who experienced a \> 2 log IU/mL decline in serum HDV RNA levels at 24 weeks of treatment
Outcome measures
| Measure |
50mg/100mg Lonafarnib/Ritonavir
n=4 Participants
Lonafarnib/Ritonavir at 50 mg/100 mg daily for 24 weeks followed by 24 weeks of off therapy follow-up.
Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.
Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily.
|
75mg/100mg Lonafarnib/Ritonavir
n=4 Participants
Lonafarnib/Ritonavir at 75 mg/100 mg daily for 24 weeks followed by 24 weeks of off therapy follow-up.
Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.
Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily.
|
100mg/100mg Lonafarnib/Ritonavir
n=3 Participants
Lonafarnib/Ritonavir at 100 mg/100 mg daily for 24 weeks followed by 24 weeks of off therapy follow-up.
Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.
Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily.
|
Placebo Then 50 mg/100 mg Lonafarnib/Ritonavir
Placebo for 12 weeks then Lonafarnib/Ritonavir at 50 mg/100 mg daily for 12 weeks followed by 24 weeks of off therapy follow-up.
Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.
Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily.
Placebo: Placebo
|
Placebo Then 75mg/100mg Lonafarnib/Ritonavir
Placebo for 12 weeks then Lonafarnib/Ritonavir at 75 mg/100 mg daily for 12 weeks followed by 24 weeks of off therapy follow-up.
Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.
Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily.
Placebo: Placebo
|
Placebo Then 100mg/100mg Lonafarnib/Ritonavir
Placebo for 12 weeks then Lonafarnib/Ritonavir at 100 mg/100 mg daily for 12 weeks followed by 24 weeks of off therapy follow-up.
Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.
Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily.
Placebo: Placebo
|
|---|---|---|---|---|---|---|
|
Number of Participants With Decline of HDV RNA Quantitative Measurement of > 2 Logs From Baseline at 24 Weeks of Treatment
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
24 Weeks of 50mg/100mg Lonafarnib/Ritonavir
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
24 Weeks of 75mg/100mg Lonafarnib/Ritonavir
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
24 Weeks of 100mg/100mg Lonafarnib/Ritonavir
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
12 Weeks of Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
12 Weeks of 50 mg/100 mg Lonafarnib/Ritonavir
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
12 Weeks of 75mg/100mg Lonafarnib/Ritonavir
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
12 Weeks of 100mg/100mg Lonafarnib/Ritonavir
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
24 Weeks of 50mg/100mg Lonafarnib/Ritonavir
n=4 participants at risk
Lonafarnib/Ritonavir at 50 mg/100 mg daily for 24 weeks.
|
24 Weeks of 75mg/100mg Lonafarnib/Ritonavir
n=4 participants at risk
Lonafarnib/Ritonavir at 75 mg/100 mg daily for 24 weeks.
|
24 Weeks of 100mg/100mg Lonafarnib/Ritonavir
n=4 participants at risk
Lonafarnib/Ritonavir at 100 mg/100 mg daily for 24 weeks.
|
12 Weeks of Placebo
n=9 participants at risk
Placebo for first 12 weeks.
|
12 Weeks of 50 mg/100 mg Lonafarnib/Ritonavir
n=3 participants at risk
Lonafarnib/Ritonavir at 50 mg/100 mg daily for second 12 weeks.
|
12 Weeks of 75mg/100mg Lonafarnib/Ritonavir
n=3 participants at risk
Lonafarnib/Ritonavir at 75 mg/100 mg daily for second 12 weeks.
|
12 Weeks of 100mg/100mg Lonafarnib/Ritonavir
n=3 participants at risk
Lonafarnib/Ritonavir at 100 mg/100 mg daily for second 12 weeks.
|
|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Syncope
|
25.0%
1/4 • For the 12 patients in arms 1, 2 and 3 (24 weeks of treatment), adverse event data were collected over the 24 weeks of treatment and are reported per arm. For patients in arms 4, 5 and 6 (12 weeks placebo then 12 weeks active treatment), adverse event data for the placebo portion of the study were collected over the 12 weeks of placebo administration (reported in aggregate) and the 12 weeks of active treatment (reported per arm).
|
0.00%
0/4 • For the 12 patients in arms 1, 2 and 3 (24 weeks of treatment), adverse event data were collected over the 24 weeks of treatment and are reported per arm. For patients in arms 4, 5 and 6 (12 weeks placebo then 12 weeks active treatment), adverse event data for the placebo portion of the study were collected over the 12 weeks of placebo administration (reported in aggregate) and the 12 weeks of active treatment (reported per arm).
|
0.00%
0/4 • For the 12 patients in arms 1, 2 and 3 (24 weeks of treatment), adverse event data were collected over the 24 weeks of treatment and are reported per arm. For patients in arms 4, 5 and 6 (12 weeks placebo then 12 weeks active treatment), adverse event data for the placebo portion of the study were collected over the 12 weeks of placebo administration (reported in aggregate) and the 12 weeks of active treatment (reported per arm).
|
0.00%
0/9 • For the 12 patients in arms 1, 2 and 3 (24 weeks of treatment), adverse event data were collected over the 24 weeks of treatment and are reported per arm. For patients in arms 4, 5 and 6 (12 weeks placebo then 12 weeks active treatment), adverse event data for the placebo portion of the study were collected over the 12 weeks of placebo administration (reported in aggregate) and the 12 weeks of active treatment (reported per arm).
|
0.00%
0/3 • For the 12 patients in arms 1, 2 and 3 (24 weeks of treatment), adverse event data were collected over the 24 weeks of treatment and are reported per arm. For patients in arms 4, 5 and 6 (12 weeks placebo then 12 weeks active treatment), adverse event data for the placebo portion of the study were collected over the 12 weeks of placebo administration (reported in aggregate) and the 12 weeks of active treatment (reported per arm).
|
0.00%
0/3 • For the 12 patients in arms 1, 2 and 3 (24 weeks of treatment), adverse event data were collected over the 24 weeks of treatment and are reported per arm. For patients in arms 4, 5 and 6 (12 weeks placebo then 12 weeks active treatment), adverse event data for the placebo portion of the study were collected over the 12 weeks of placebo administration (reported in aggregate) and the 12 weeks of active treatment (reported per arm).
|
0.00%
0/3 • For the 12 patients in arms 1, 2 and 3 (24 weeks of treatment), adverse event data were collected over the 24 weeks of treatment and are reported per arm. For patients in arms 4, 5 and 6 (12 weeks placebo then 12 weeks active treatment), adverse event data for the placebo portion of the study were collected over the 12 weeks of placebo administration (reported in aggregate) and the 12 weeks of active treatment (reported per arm).
|
Other adverse events
| Measure |
24 Weeks of 50mg/100mg Lonafarnib/Ritonavir
n=4 participants at risk
Lonafarnib/Ritonavir at 50 mg/100 mg daily for 24 weeks.
|
24 Weeks of 75mg/100mg Lonafarnib/Ritonavir
n=4 participants at risk
Lonafarnib/Ritonavir at 75 mg/100 mg daily for 24 weeks.
|
24 Weeks of 100mg/100mg Lonafarnib/Ritonavir
n=4 participants at risk
Lonafarnib/Ritonavir at 100 mg/100 mg daily for 24 weeks.
|
12 Weeks of Placebo
n=9 participants at risk
Placebo for first 12 weeks.
|
12 Weeks of 50 mg/100 mg Lonafarnib/Ritonavir
n=3 participants at risk
Lonafarnib/Ritonavir at 50 mg/100 mg daily for second 12 weeks.
|
12 Weeks of 75mg/100mg Lonafarnib/Ritonavir
n=3 participants at risk
Lonafarnib/Ritonavir at 75 mg/100 mg daily for second 12 weeks.
|
12 Weeks of 100mg/100mg Lonafarnib/Ritonavir
n=3 participants at risk
Lonafarnib/Ritonavir at 100 mg/100 mg daily for second 12 weeks.
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • For the 12 patients in arms 1, 2 and 3 (24 weeks of treatment), adverse event data were collected over the 24 weeks of treatment and are reported per arm. For patients in arms 4, 5 and 6 (12 weeks placebo then 12 weeks active treatment), adverse event data for the placebo portion of the study were collected over the 12 weeks of placebo administration (reported in aggregate) and the 12 weeks of active treatment (reported per arm).
|
75.0%
3/4 • For the 12 patients in arms 1, 2 and 3 (24 weeks of treatment), adverse event data were collected over the 24 weeks of treatment and are reported per arm. For patients in arms 4, 5 and 6 (12 weeks placebo then 12 weeks active treatment), adverse event data for the placebo portion of the study were collected over the 12 weeks of placebo administration (reported in aggregate) and the 12 weeks of active treatment (reported per arm).
|
50.0%
2/4 • For the 12 patients in arms 1, 2 and 3 (24 weeks of treatment), adverse event data were collected over the 24 weeks of treatment and are reported per arm. For patients in arms 4, 5 and 6 (12 weeks placebo then 12 weeks active treatment), adverse event data for the placebo portion of the study were collected over the 12 weeks of placebo administration (reported in aggregate) and the 12 weeks of active treatment (reported per arm).
|
33.3%
3/9 • For the 12 patients in arms 1, 2 and 3 (24 weeks of treatment), adverse event data were collected over the 24 weeks of treatment and are reported per arm. For patients in arms 4, 5 and 6 (12 weeks placebo then 12 weeks active treatment), adverse event data for the placebo portion of the study were collected over the 12 weeks of placebo administration (reported in aggregate) and the 12 weeks of active treatment (reported per arm).
|
33.3%
1/3 • For the 12 patients in arms 1, 2 and 3 (24 weeks of treatment), adverse event data were collected over the 24 weeks of treatment and are reported per arm. For patients in arms 4, 5 and 6 (12 weeks placebo then 12 weeks active treatment), adverse event data for the placebo portion of the study were collected over the 12 weeks of placebo administration (reported in aggregate) and the 12 weeks of active treatment (reported per arm).
|
66.7%
2/3 • For the 12 patients in arms 1, 2 and 3 (24 weeks of treatment), adverse event data were collected over the 24 weeks of treatment and are reported per arm. For patients in arms 4, 5 and 6 (12 weeks placebo then 12 weeks active treatment), adverse event data for the placebo portion of the study were collected over the 12 weeks of placebo administration (reported in aggregate) and the 12 weeks of active treatment (reported per arm).
|
0.00%
0/3 • For the 12 patients in arms 1, 2 and 3 (24 weeks of treatment), adverse event data were collected over the 24 weeks of treatment and are reported per arm. For patients in arms 4, 5 and 6 (12 weeks placebo then 12 weeks active treatment), adverse event data for the placebo portion of the study were collected over the 12 weeks of placebo administration (reported in aggregate) and the 12 weeks of active treatment (reported per arm).
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/4 • For the 12 patients in arms 1, 2 and 3 (24 weeks of treatment), adverse event data were collected over the 24 weeks of treatment and are reported per arm. For patients in arms 4, 5 and 6 (12 weeks placebo then 12 weeks active treatment), adverse event data for the placebo portion of the study were collected over the 12 weeks of placebo administration (reported in aggregate) and the 12 weeks of active treatment (reported per arm).
|
75.0%
3/4 • For the 12 patients in arms 1, 2 and 3 (24 weeks of treatment), adverse event data were collected over the 24 weeks of treatment and are reported per arm. For patients in arms 4, 5 and 6 (12 weeks placebo then 12 weeks active treatment), adverse event data for the placebo portion of the study were collected over the 12 weeks of placebo administration (reported in aggregate) and the 12 weeks of active treatment (reported per arm).
|
75.0%
3/4 • For the 12 patients in arms 1, 2 and 3 (24 weeks of treatment), adverse event data were collected over the 24 weeks of treatment and are reported per arm. For patients in arms 4, 5 and 6 (12 weeks placebo then 12 weeks active treatment), adverse event data for the placebo portion of the study were collected over the 12 weeks of placebo administration (reported in aggregate) and the 12 weeks of active treatment (reported per arm).
|
44.4%
4/9 • For the 12 patients in arms 1, 2 and 3 (24 weeks of treatment), adverse event data were collected over the 24 weeks of treatment and are reported per arm. For patients in arms 4, 5 and 6 (12 weeks placebo then 12 weeks active treatment), adverse event data for the placebo portion of the study were collected over the 12 weeks of placebo administration (reported in aggregate) and the 12 weeks of active treatment (reported per arm).
|
66.7%
2/3 • For the 12 patients in arms 1, 2 and 3 (24 weeks of treatment), adverse event data were collected over the 24 weeks of treatment and are reported per arm. For patients in arms 4, 5 and 6 (12 weeks placebo then 12 weeks active treatment), adverse event data for the placebo portion of the study were collected over the 12 weeks of placebo administration (reported in aggregate) and the 12 weeks of active treatment (reported per arm).
|
100.0%
3/3 • For the 12 patients in arms 1, 2 and 3 (24 weeks of treatment), adverse event data were collected over the 24 weeks of treatment and are reported per arm. For patients in arms 4, 5 and 6 (12 weeks placebo then 12 weeks active treatment), adverse event data for the placebo portion of the study were collected over the 12 weeks of placebo administration (reported in aggregate) and the 12 weeks of active treatment (reported per arm).
|
33.3%
1/3 • For the 12 patients in arms 1, 2 and 3 (24 weeks of treatment), adverse event data were collected over the 24 weeks of treatment and are reported per arm. For patients in arms 4, 5 and 6 (12 weeks placebo then 12 weeks active treatment), adverse event data for the placebo portion of the study were collected over the 12 weeks of placebo administration (reported in aggregate) and the 12 weeks of active treatment (reported per arm).
|
|
Metabolism and nutrition disorders
Anorexia
|
25.0%
1/4 • For the 12 patients in arms 1, 2 and 3 (24 weeks of treatment), adverse event data were collected over the 24 weeks of treatment and are reported per arm. For patients in arms 4, 5 and 6 (12 weeks placebo then 12 weeks active treatment), adverse event data for the placebo portion of the study were collected over the 12 weeks of placebo administration (reported in aggregate) and the 12 weeks of active treatment (reported per arm).
|
75.0%
3/4 • For the 12 patients in arms 1, 2 and 3 (24 weeks of treatment), adverse event data were collected over the 24 weeks of treatment and are reported per arm. For patients in arms 4, 5 and 6 (12 weeks placebo then 12 weeks active treatment), adverse event data for the placebo portion of the study were collected over the 12 weeks of placebo administration (reported in aggregate) and the 12 weeks of active treatment (reported per arm).
|
25.0%
1/4 • For the 12 patients in arms 1, 2 and 3 (24 weeks of treatment), adverse event data were collected over the 24 weeks of treatment and are reported per arm. For patients in arms 4, 5 and 6 (12 weeks placebo then 12 weeks active treatment), adverse event data for the placebo portion of the study were collected over the 12 weeks of placebo administration (reported in aggregate) and the 12 weeks of active treatment (reported per arm).
|
55.6%
5/9 • For the 12 patients in arms 1, 2 and 3 (24 weeks of treatment), adverse event data were collected over the 24 weeks of treatment and are reported per arm. For patients in arms 4, 5 and 6 (12 weeks placebo then 12 weeks active treatment), adverse event data for the placebo portion of the study were collected over the 12 weeks of placebo administration (reported in aggregate) and the 12 weeks of active treatment (reported per arm).
|
33.3%
1/3 • For the 12 patients in arms 1, 2 and 3 (24 weeks of treatment), adverse event data were collected over the 24 weeks of treatment and are reported per arm. For patients in arms 4, 5 and 6 (12 weeks placebo then 12 weeks active treatment), adverse event data for the placebo portion of the study were collected over the 12 weeks of placebo administration (reported in aggregate) and the 12 weeks of active treatment (reported per arm).
|
66.7%
2/3 • For the 12 patients in arms 1, 2 and 3 (24 weeks of treatment), adverse event data were collected over the 24 weeks of treatment and are reported per arm. For patients in arms 4, 5 and 6 (12 weeks placebo then 12 weeks active treatment), adverse event data for the placebo portion of the study were collected over the 12 weeks of placebo administration (reported in aggregate) and the 12 weeks of active treatment (reported per arm).
|
33.3%
1/3 • For the 12 patients in arms 1, 2 and 3 (24 weeks of treatment), adverse event data were collected over the 24 weeks of treatment and are reported per arm. For patients in arms 4, 5 and 6 (12 weeks placebo then 12 weeks active treatment), adverse event data for the placebo portion of the study were collected over the 12 weeks of placebo administration (reported in aggregate) and the 12 weeks of active treatment (reported per arm).
|
|
Gastrointestinal disorders
Bloating
|
50.0%
2/4 • For the 12 patients in arms 1, 2 and 3 (24 weeks of treatment), adverse event data were collected over the 24 weeks of treatment and are reported per arm. For patients in arms 4, 5 and 6 (12 weeks placebo then 12 weeks active treatment), adverse event data for the placebo portion of the study were collected over the 12 weeks of placebo administration (reported in aggregate) and the 12 weeks of active treatment (reported per arm).
|
25.0%
1/4 • For the 12 patients in arms 1, 2 and 3 (24 weeks of treatment), adverse event data were collected over the 24 weeks of treatment and are reported per arm. For patients in arms 4, 5 and 6 (12 weeks placebo then 12 weeks active treatment), adverse event data for the placebo portion of the study were collected over the 12 weeks of placebo administration (reported in aggregate) and the 12 weeks of active treatment (reported per arm).
|
50.0%
2/4 • For the 12 patients in arms 1, 2 and 3 (24 weeks of treatment), adverse event data were collected over the 24 weeks of treatment and are reported per arm. For patients in arms 4, 5 and 6 (12 weeks placebo then 12 weeks active treatment), adverse event data for the placebo portion of the study were collected over the 12 weeks of placebo administration (reported in aggregate) and the 12 weeks of active treatment (reported per arm).
|
44.4%
4/9 • For the 12 patients in arms 1, 2 and 3 (24 weeks of treatment), adverse event data were collected over the 24 weeks of treatment and are reported per arm. For patients in arms 4, 5 and 6 (12 weeks placebo then 12 weeks active treatment), adverse event data for the placebo portion of the study were collected over the 12 weeks of placebo administration (reported in aggregate) and the 12 weeks of active treatment (reported per arm).
|
33.3%
1/3 • For the 12 patients in arms 1, 2 and 3 (24 weeks of treatment), adverse event data were collected over the 24 weeks of treatment and are reported per arm. For patients in arms 4, 5 and 6 (12 weeks placebo then 12 weeks active treatment), adverse event data for the placebo portion of the study were collected over the 12 weeks of placebo administration (reported in aggregate) and the 12 weeks of active treatment (reported per arm).
|
100.0%
3/3 • For the 12 patients in arms 1, 2 and 3 (24 weeks of treatment), adverse event data were collected over the 24 weeks of treatment and are reported per arm. For patients in arms 4, 5 and 6 (12 weeks placebo then 12 weeks active treatment), adverse event data for the placebo portion of the study were collected over the 12 weeks of placebo administration (reported in aggregate) and the 12 weeks of active treatment (reported per arm).
|
33.3%
1/3 • For the 12 patients in arms 1, 2 and 3 (24 weeks of treatment), adverse event data were collected over the 24 weeks of treatment and are reported per arm. For patients in arms 4, 5 and 6 (12 weeks placebo then 12 weeks active treatment), adverse event data for the placebo portion of the study were collected over the 12 weeks of placebo administration (reported in aggregate) and the 12 weeks of active treatment (reported per arm).
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • For the 12 patients in arms 1, 2 and 3 (24 weeks of treatment), adverse event data were collected over the 24 weeks of treatment and are reported per arm. For patients in arms 4, 5 and 6 (12 weeks placebo then 12 weeks active treatment), adverse event data for the placebo portion of the study were collected over the 12 weeks of placebo administration (reported in aggregate) and the 12 weeks of active treatment (reported per arm).
|
25.0%
1/4 • For the 12 patients in arms 1, 2 and 3 (24 weeks of treatment), adverse event data were collected over the 24 weeks of treatment and are reported per arm. For patients in arms 4, 5 and 6 (12 weeks placebo then 12 weeks active treatment), adverse event data for the placebo portion of the study were collected over the 12 weeks of placebo administration (reported in aggregate) and the 12 weeks of active treatment (reported per arm).
|
25.0%
1/4 • For the 12 patients in arms 1, 2 and 3 (24 weeks of treatment), adverse event data were collected over the 24 weeks of treatment and are reported per arm. For patients in arms 4, 5 and 6 (12 weeks placebo then 12 weeks active treatment), adverse event data for the placebo portion of the study were collected over the 12 weeks of placebo administration (reported in aggregate) and the 12 weeks of active treatment (reported per arm).
|
11.1%
1/9 • For the 12 patients in arms 1, 2 and 3 (24 weeks of treatment), adverse event data were collected over the 24 weeks of treatment and are reported per arm. For patients in arms 4, 5 and 6 (12 weeks placebo then 12 weeks active treatment), adverse event data for the placebo portion of the study were collected over the 12 weeks of placebo administration (reported in aggregate) and the 12 weeks of active treatment (reported per arm).
|
33.3%
1/3 • For the 12 patients in arms 1, 2 and 3 (24 weeks of treatment), adverse event data were collected over the 24 weeks of treatment and are reported per arm. For patients in arms 4, 5 and 6 (12 weeks placebo then 12 weeks active treatment), adverse event data for the placebo portion of the study were collected over the 12 weeks of placebo administration (reported in aggregate) and the 12 weeks of active treatment (reported per arm).
|
0.00%
0/3 • For the 12 patients in arms 1, 2 and 3 (24 weeks of treatment), adverse event data were collected over the 24 weeks of treatment and are reported per arm. For patients in arms 4, 5 and 6 (12 weeks placebo then 12 weeks active treatment), adverse event data for the placebo portion of the study were collected over the 12 weeks of placebo administration (reported in aggregate) and the 12 weeks of active treatment (reported per arm).
|
0.00%
0/3 • For the 12 patients in arms 1, 2 and 3 (24 weeks of treatment), adverse event data were collected over the 24 weeks of treatment and are reported per arm. For patients in arms 4, 5 and 6 (12 weeks placebo then 12 weeks active treatment), adverse event data for the placebo portion of the study were collected over the 12 weeks of placebo administration (reported in aggregate) and the 12 weeks of active treatment (reported per arm).
|
|
Nervous system disorders
Dizziness
|
25.0%
1/4 • For the 12 patients in arms 1, 2 and 3 (24 weeks of treatment), adverse event data were collected over the 24 weeks of treatment and are reported per arm. For patients in arms 4, 5 and 6 (12 weeks placebo then 12 weeks active treatment), adverse event data for the placebo portion of the study were collected over the 12 weeks of placebo administration (reported in aggregate) and the 12 weeks of active treatment (reported per arm).
|
0.00%
0/4 • For the 12 patients in arms 1, 2 and 3 (24 weeks of treatment), adverse event data were collected over the 24 weeks of treatment and are reported per arm. For patients in arms 4, 5 and 6 (12 weeks placebo then 12 weeks active treatment), adverse event data for the placebo portion of the study were collected over the 12 weeks of placebo administration (reported in aggregate) and the 12 weeks of active treatment (reported per arm).
|
0.00%
0/4 • For the 12 patients in arms 1, 2 and 3 (24 weeks of treatment), adverse event data were collected over the 24 weeks of treatment and are reported per arm. For patients in arms 4, 5 and 6 (12 weeks placebo then 12 weeks active treatment), adverse event data for the placebo portion of the study were collected over the 12 weeks of placebo administration (reported in aggregate) and the 12 weeks of active treatment (reported per arm).
|
0.00%
0/9 • For the 12 patients in arms 1, 2 and 3 (24 weeks of treatment), adverse event data were collected over the 24 weeks of treatment and are reported per arm. For patients in arms 4, 5 and 6 (12 weeks placebo then 12 weeks active treatment), adverse event data for the placebo portion of the study were collected over the 12 weeks of placebo administration (reported in aggregate) and the 12 weeks of active treatment (reported per arm).
|
0.00%
0/3 • For the 12 patients in arms 1, 2 and 3 (24 weeks of treatment), adverse event data were collected over the 24 weeks of treatment and are reported per arm. For patients in arms 4, 5 and 6 (12 weeks placebo then 12 weeks active treatment), adverse event data for the placebo portion of the study were collected over the 12 weeks of placebo administration (reported in aggregate) and the 12 weeks of active treatment (reported per arm).
|
0.00%
0/3 • For the 12 patients in arms 1, 2 and 3 (24 weeks of treatment), adverse event data were collected over the 24 weeks of treatment and are reported per arm. For patients in arms 4, 5 and 6 (12 weeks placebo then 12 weeks active treatment), adverse event data for the placebo portion of the study were collected over the 12 weeks of placebo administration (reported in aggregate) and the 12 weeks of active treatment (reported per arm).
|
0.00%
0/3 • For the 12 patients in arms 1, 2 and 3 (24 weeks of treatment), adverse event data were collected over the 24 weeks of treatment and are reported per arm. For patients in arms 4, 5 and 6 (12 weeks placebo then 12 weeks active treatment), adverse event data for the placebo portion of the study were collected over the 12 weeks of placebo administration (reported in aggregate) and the 12 weeks of active treatment (reported per arm).
|
|
General disorders
Fatigue
|
50.0%
2/4 • For the 12 patients in arms 1, 2 and 3 (24 weeks of treatment), adverse event data were collected over the 24 weeks of treatment and are reported per arm. For patients in arms 4, 5 and 6 (12 weeks placebo then 12 weeks active treatment), adverse event data for the placebo portion of the study were collected over the 12 weeks of placebo administration (reported in aggregate) and the 12 weeks of active treatment (reported per arm).
|
50.0%
2/4 • For the 12 patients in arms 1, 2 and 3 (24 weeks of treatment), adverse event data were collected over the 24 weeks of treatment and are reported per arm. For patients in arms 4, 5 and 6 (12 weeks placebo then 12 weeks active treatment), adverse event data for the placebo portion of the study were collected over the 12 weeks of placebo administration (reported in aggregate) and the 12 weeks of active treatment (reported per arm).
|
75.0%
3/4 • For the 12 patients in arms 1, 2 and 3 (24 weeks of treatment), adverse event data were collected over the 24 weeks of treatment and are reported per arm. For patients in arms 4, 5 and 6 (12 weeks placebo then 12 weeks active treatment), adverse event data for the placebo portion of the study were collected over the 12 weeks of placebo administration (reported in aggregate) and the 12 weeks of active treatment (reported per arm).
|
55.6%
5/9 • For the 12 patients in arms 1, 2 and 3 (24 weeks of treatment), adverse event data were collected over the 24 weeks of treatment and are reported per arm. For patients in arms 4, 5 and 6 (12 weeks placebo then 12 weeks active treatment), adverse event data for the placebo portion of the study were collected over the 12 weeks of placebo administration (reported in aggregate) and the 12 weeks of active treatment (reported per arm).
|
33.3%
1/3 • For the 12 patients in arms 1, 2 and 3 (24 weeks of treatment), adverse event data were collected over the 24 weeks of treatment and are reported per arm. For patients in arms 4, 5 and 6 (12 weeks placebo then 12 weeks active treatment), adverse event data for the placebo portion of the study were collected over the 12 weeks of placebo administration (reported in aggregate) and the 12 weeks of active treatment (reported per arm).
|
66.7%
2/3 • For the 12 patients in arms 1, 2 and 3 (24 weeks of treatment), adverse event data were collected over the 24 weeks of treatment and are reported per arm. For patients in arms 4, 5 and 6 (12 weeks placebo then 12 weeks active treatment), adverse event data for the placebo portion of the study were collected over the 12 weeks of placebo administration (reported in aggregate) and the 12 weeks of active treatment (reported per arm).
|
0.00%
0/3 • For the 12 patients in arms 1, 2 and 3 (24 weeks of treatment), adverse event data were collected over the 24 weeks of treatment and are reported per arm. For patients in arms 4, 5 and 6 (12 weeks placebo then 12 weeks active treatment), adverse event data for the placebo portion of the study were collected over the 12 weeks of placebo administration (reported in aggregate) and the 12 weeks of active treatment (reported per arm).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place