Trial Outcomes & Findings for Lonafarnib With and Without Ritonavir in HDV (LOWR-1) (NCT NCT02430181)
NCT ID: NCT02430181
Last Updated: 2022-11-29
Results Overview
log HDV RNA decline from baseline to end of treatment (4-12 weeks of lonafarnib-based therapy)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
21 participants
Primary outcome timeframe
4-12 weeks
Results posted on
2022-11-29
Participant Flow
Participant milestones
| Measure |
Lonafarnib - I
lonafarnib 200 mg BID; n=3
lonafarnib: antiviral farnesyl transferase inhibitor
|
Lonafarnib - II
lonafarnib 300 mg BID; n=3
lonafarnib: antiviral farnesyl transferase inhibitor
|
Lonafarnib - III
lonafarnib 100 mg TID; n=3
lonafarnib: antiviral farnesyl transferase inhibitor
|
Lonafarnib/PEG IFN-a - I
lonafarnib 100 mg BID + PEG IFN-a 180 ug QW; n=3
lonafarnib: antiviral farnesyl transferase inhibitor
PEG IFN-a: immunomodulator
|
Lonafarnib/PEG IFN-a - II
lonafarnib 200 mg BID + PEG IFN-a 180 ug QW; n=3
lonafarnib: antiviral farnesyl transferase inhibitor
PEG IFN-a: immunomodulator
|
Lonafarnib/PEG IFN-a - III
lonafarnib 300 mg BID + PEG IFN-a 180 ug QW; n=2
lonafarnib: antiviral farnesyl transferase inhibitor
PEG IFN-a: immunomodulator
|
Lonafarnib/Ritonavir
lonafarnib 100 mg BID + ritonavir 100 mg QD; n=3
lonafarnib: antiviral farnesyl transferase inhibitor
Ritonavir: CYP 3A4 inhibitor, lonafarnib booster
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
3
|
3
|
2
|
3
|
|
Overall Study
COMPLETED
|
3
|
3
|
2
|
3
|
3
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
2
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lonafarnib With and Without Ritonavir in HDV (LOWR-1)
Baseline characteristics by cohort
| Measure |
Lonafarnib 200 mg BID
n=3 Participants
lonafarnib 200 mg BID; n=3
lonafarnib: antiviral farnesyl transferase inhibitor
|
Lonafarnib 300 mg BID
n=3 Participants
lonafarnib 300 mg BID; n=3
lonafarnib: antiviral farnesyl transferase inhibitor
|
Lonafarnib 100 mg TID
n=3 Participants
lonafarnib 100 mg TID; n=3
lonafarnib: antiviral farnesyl transferase inhibitor
|
100 mg BID Lonafarnib/PEG IFN-a
n=3 Participants
lonafarnib 100 mg BID + PEG IFN-a 180 ug QW; n=3
lonafarnib: antiviral farnesyl transferase inhibitor
PEG IFN-a: immunomodulator
|
200 mg BID Lonafarnib/PEG IFN-a
n=3 Participants
lonafarnib 200 mg BID + PEG IFN-a 180 ug QW; n=3
lonafarnib: antiviral farnesyl transferase inhibitor
PEG IFN-a: immunomodulator
|
300 mg BID Lonafarnib/PEG IFN-a
n=2 Participants
lonafarnib 300 mg BID + PEG IFN-a 180 ug QW; n=3
lonafarnib: antiviral farnesyl transferase inhibitor
PEG IFN-a: immunomodulator
|
Lonafarnib/Ritonavir
n=3 Participants
lonafarnib 100 mg BID + ritonavir 100 mg QD; n=3
lonafarnib: antiviral farnesyl transferase inhibitor
Ritonavir: CYP 3A4 inhibitor, lonafarnib booster
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
59 years
n=5 Participants
|
40 years
n=7 Participants
|
46 years
n=5 Participants
|
41 years
n=4 Participants
|
46 years
n=21 Participants
|
49 years
n=8 Participants
|
51 years
n=8 Participants
|
49 years
n=24 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
13 Participants
n=24 Participants
|
|
Region of Enrollment
Turkey
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
3 participants
n=4 Participants
|
3 participants
n=21 Participants
|
2 participants
n=8 Participants
|
3 participants
n=8 Participants
|
20 participants
n=24 Participants
|
PRIMARY outcome
Timeframe: 4-12 weekslog HDV RNA decline from baseline to end of treatment (4-12 weeks of lonafarnib-based therapy)
Outcome measures
| Measure |
Lonafarnib 200 mg BID
n=3 Participants
lonafarnib 200 mg BID; n=3
lonafarnib: antiviral farnesyl transferase inhibitor
|
Lonafarnib 300 mg BID
n=3 Participants
lonafarnib 300 mg BID; n=3
lonafarnib: antiviral farnesyl transferase inhibitor
|
Lonafarnib 100 mg TID
n=3 Participants
lonafarnib 100 mg TID; n=3
lonafarnib: antiviral farnesyl transferase inhibitor
|
100 mg BID Lonafarnib/PEG IFN-a
n=3 Participants
lonafarnib 100 mg BID + PEG IFN-a 180 ug QW; n=3
lonafarnib: antiviral farnesyl transferase inhibitor
PEG IFN-a: immunomodulator
|
200 mg BID Lonafarnib/PEG IFN-a
n=3 Participants
lonafarnib 200 mg BID + PEG IFN-a 180 ug QW; n=3
lonafarnib: antiviral farnesyl transferase inhibitor
PEG IFN-a: immunomodulator
|
300 mg BID Lonafarnib/PEG IFN-a
n=2 Participants
lonafarnib 300 mg BID + PEG IFN-a 180 ug QW; n=2
lonafarnib: antiviral farnesyl transferase inhibitor
PEG IFN-a: immunomodulator
|
Lonafarnib/Ritonavir
n=3 Participants
lonafarnib 100 mg BID + ritonavir 100 mg QD; n=3
lonafarnib: antiviral farnesyl transferase inhibitor
Ritonavir: CYP 3A4 inhibitor, lonafarnib booster
|
|---|---|---|---|---|---|---|---|
|
Improvement in Quantitative Serum HDV RNA Levels After 4-12 Weeks of Lonafarnib-based Therapy
|
0.03 log IU/mL
Interval -1.17 to 1.83
|
-1.78 log IU/mL
Interval -2.28 to -1.46
|
-1.3 log IU/mL
Interval -1.61 to -0.52
|
-1.85 log IU/mL
Interval -2.4 to -1.33
|
0 log IU/mL
Interval 0.0 to 0.0
|
0 log IU/mL
Interval 0.0 to 0.0
|
-1.2 log IU/mL
Interval -1.41 to -0.91
|
Adverse Events
Lonafarnib 200 mg BID
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Lonafarnib 300 mg BID
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Lonafarnib 100 mg TID
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
100 mg BID Lonafarnib/PEG IFN-a
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
200 mg BID Lonafarnib/PEG IFN-a
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
300 mg BID Lonafarnib/PEG IFN-a
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Lonafarnib/Ritonavir
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lonafarnib 200 mg BID
n=3 participants at risk
lonafarnib 200 mg BID; n=3
lonafarnib: antiviral farnesyl transferase inhibitor
|
Lonafarnib 300 mg BID
n=3 participants at risk
lonafarnib 300 mg BID; n=3
lonafarnib: antiviral farnesyl transferase inhibitor
|
Lonafarnib 100 mg TID
n=3 participants at risk
lonafarnib 100 mg TID; n=3
lonafarnib: antiviral farnesyl transferase inhibitor
|
100 mg BID Lonafarnib/PEG IFN-a
n=3 participants at risk
lonafarnib 100 mg BID + PEG IFN-a 180 ug QW; n=3
lonafarnib: antiviral farnesyl transferase inhibitor
PEG IFN-a: immunomodulator
|
200 mg BID Lonafarnib/PEG IFN-a
n=3 participants at risk
lonafarnib 200 mg BID + PEG IFN-a 180 ug QW; n=3
lonafarnib: antiviral farnesyl transferase inhibitor
PEG IFN-a: immunomodulator
|
300 mg BID Lonafarnib/PEG IFN-a
n=2 participants at risk
lonafarnib 300 mg BID + PEG IFN-a 180 ug QW; n=2
lonafarnib: antiviral farnesyl transferase inhibitor
PEG IFN-a: immunomodulator
|
Lonafarnib/Ritonavir
n=3 participants at risk
lonafarnib 100 mg BID + ritonavir 100 mg QD; n=3
lonafarnib: antiviral farnesyl transferase inhibitor
Ritonavir: CYP 3A4 inhibitor, lonafarnib booster
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
dehydration secondary to vomiting and diarrhea
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/3
|
Other adverse events
| Measure |
Lonafarnib 200 mg BID
n=3 participants at risk
lonafarnib 200 mg BID; n=3
lonafarnib: antiviral farnesyl transferase inhibitor
|
Lonafarnib 300 mg BID
n=3 participants at risk
lonafarnib 300 mg BID; n=3
lonafarnib: antiviral farnesyl transferase inhibitor
|
Lonafarnib 100 mg TID
n=3 participants at risk
lonafarnib 100 mg TID; n=3
lonafarnib: antiviral farnesyl transferase inhibitor
|
100 mg BID Lonafarnib/PEG IFN-a
n=3 participants at risk
lonafarnib 100 mg BID + PEG IFN-a 180 ug QW; n=3
lonafarnib: antiviral farnesyl transferase inhibitor
PEG IFN-a: immunomodulator
|
200 mg BID Lonafarnib/PEG IFN-a
n=3 participants at risk
lonafarnib 200 mg BID + PEG IFN-a 180 ug QW; n=3
lonafarnib: antiviral farnesyl transferase inhibitor
PEG IFN-a: immunomodulator
|
300 mg BID Lonafarnib/PEG IFN-a
n=2 participants at risk
lonafarnib 300 mg BID + PEG IFN-a 180 ug QW; n=2
lonafarnib: antiviral farnesyl transferase inhibitor
PEG IFN-a: immunomodulator
|
Lonafarnib/Ritonavir
n=3 participants at risk
lonafarnib 100 mg BID + ritonavir 100 mg QD; n=3
lonafarnib: antiviral farnesyl transferase inhibitor
Ritonavir: CYP 3A4 inhibitor, lonafarnib booster
|
|---|---|---|---|---|---|---|---|
|
Investigations
weight loss
|
100.0%
3/3
|
100.0%
3/3
|
66.7%
2/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/2
|
66.7%
2/3
|
|
Gastrointestinal disorders
diarrhea
|
100.0%
3/3
|
100.0%
3/3
|
66.7%
2/3
|
100.0%
3/3
|
0.00%
0/3
|
0.00%
0/2
|
100.0%
3/3
|
|
Gastrointestinal disorders
nausea
|
100.0%
3/3
|
100.0%
3/3
|
66.7%
2/3
|
100.0%
3/3
|
0.00%
0/3
|
0.00%
0/2
|
100.0%
3/3
|
|
General disorders
fatigue
|
100.0%
3/3
|
66.7%
2/3
|
66.7%
2/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/2
|
66.7%
2/3
|
|
Gastrointestinal disorders
vomiting
|
66.7%
2/3
|
100.0%
3/3
|
66.7%
2/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/2
|
33.3%
1/3
|
Additional Information
Senior VP, Clinical Development
Eiger BioPharmaceuticals, Inc
Phone: 1-650-618-1621
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place