Trial Outcomes & Findings for Lonafarnib for Chronic Hepatitis D (NCT NCT01495585)
NCT ID: NCT01495585
Last Updated: 2016-08-31
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
14 participants
Primary outcome timeframe
28 days
Results posted on
2016-08-31
Participant Flow
In Group 1, participants were randomized either placebo or lonafarnib 100 mg. In Group2, participants were randomized into either placebo or lonafarnib 200 mg.
Participant milestones
| Measure |
Placebo
Two placebo participants in Group1 and two placebo participants in Group 2. The two placebo participants in Group 1 received open label lonafarnib 200 mg.
|
Lonafarnib 100 mg
6 participants were randomized to Lonafarnib 100 mg.
|
Lonafarnib 200 mg
4 participants were randomized to Lonafarnib 200 mg.
|
|---|---|---|---|
|
Overall Study
STARTED
|
4
|
6
|
4
|
|
Overall Study
Open Label Lonafarnib 200 mg
|
2
|
0
|
0
|
|
Overall Study
COMPLETED
|
4
|
6
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lonafarnib for Chronic Hepatitis D
Baseline characteristics by cohort
| Measure |
Placebo
n=4 Participants
placebo control.
|
Lonafarnib 100 mg
n=6 Participants
6 participants were randomized to Lonafarnib 100 mg.
|
Lonafarnib 200 mg
n=6 Participants
4 participants were randomized to Lonafarnib 200 mg and two "Placebo" participants in Lonafarnib 100 mg arm received open label lonafarnib 200 mg .
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
34 years
n=99 Participants
|
36 years
n=107 Participants
|
45 years
n=206 Participants
|
38 years
n=7 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
|
Body mass index
|
26.5 kg/m^2
n=99 Participants
|
22.8 kg/m^2
n=107 Participants
|
26.1 kg/m^2
n=206 Participants
|
24.4 kg/m^2
n=7 Participants
|
|
Pre-treatment mucleoside analogues
yes
|
1 participants
n=99 Participants
|
2 participants
n=107 Participants
|
2 participants
n=206 Participants
|
5 participants
n=7 Participants
|
|
Pre-treatment mucleoside analogues
no
|
3 participants
n=99 Participants
|
4 participants
n=107 Participants
|
4 participants
n=206 Participants
|
11 participants
n=7 Participants
|
|
Ethnic origin
Asian
|
2 participants
n=99 Participants
|
3 participants
n=107 Participants
|
3 participants
n=206 Participants
|
8 participants
n=7 Participants
|
|
Ethnic origin
White
|
1 participants
n=99 Participants
|
3 participants
n=107 Participants
|
3 participants
n=206 Participants
|
7 participants
n=7 Participants
|
|
Ethnic origin
African
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
1 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 28 daysOutcome measures
| Measure |
Placebo
n=4 Participants
placebo control.
Group 1 placebo participants received open-label lonafarnib as group 2 participants.
Each group consisted of 8 participants (6 lonafarnib ands 2 placebo).
|
Group 1
n=6 Participants
lonafarnib 100 mg
|
Group 2
n=6 Participants
lonafarnib 200 mg
|
|---|---|---|---|
|
Change in Quantitative Serum HDV RNA Levels After 28 Days of Lonafarnib Therapy.
|
-0.13 log(IU/ml)
Standard Deviation 0.14
|
-0.73 log(IU/ml)
Standard Deviation 0.54
|
-1.54 log(IU/ml)
Standard Deviation 0.36
|
SECONDARY outcome
Timeframe: 7 monthsOutcome measures
| Measure |
Placebo
n=4 Participants
placebo control.
Group 1 placebo participants received open-label lonafarnib as group 2 participants.
Each group consisted of 8 participants (6 lonafarnib ands 2 placebo).
|
Group 1
n=6 Participants
lonafarnib 100 mg
|
Group 2
n=6 Participants
lonafarnib 200 mg
|
|---|---|---|---|
|
ALT Levels
|
18 U/L
Standard Deviation 13
|
4 U/L
Standard Deviation 93
|
29 U/L
Standard Deviation 85
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Group 1
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Group 2
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=4 participants at risk
placebo control.
Group 1 placebo participants received open-label lonafarnib as group 2 participants.
Each group consisted of 8 participants (6 lonafarnib ands 2 placebo).
|
Group 1
n=6 participants at risk
lonafarnib 100 mg
|
Group 2
n=6 participants at risk
lonafarnib 200 mg
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • Number of events 1 • 7 months
|
16.7%
1/6 • Number of events 2 • 7 months
|
83.3%
5/6 • Number of events 6 • 7 months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • 7 months
|
50.0%
3/6 • Number of events 3 • 7 months
|
100.0%
6/6 • Number of events 6 • 7 months
|
|
Gastrointestinal disorders
Decreased appetite
|
0.00%
0/4 • 7 months
|
16.7%
1/6 • Number of events 1 • 7 months
|
83.3%
5/6 • Number of events 5 • 7 months
|
|
Gastrointestinal disorders
Abdominal bloating/dyspepsia
|
25.0%
1/4 • Number of events 1 • 7 months
|
16.7%
1/6 • Number of events 1 • 7 months
|
100.0%
6/6 • Number of events 6 • 7 months
|
|
Gastrointestinal disorders
Vomitting
|
0.00%
0/4 • 7 months
|
0.00%
0/6 • 7 months
|
50.0%
3/6 • Number of events 3 • 7 months
|
|
Metabolism and nutrition disorders
Weight loss > 2kg
|
0.00%
0/4 • 7 months
|
16.7%
1/6 • Number of events 1 • 7 months
|
100.0%
6/6 • Number of events 6 • 7 months
|
|
General disorders
Fatigue
|
0.00%
0/4 • 7 months
|
16.7%
1/6 • Number of events 1 • 7 months
|
16.7%
1/6 • Number of events 1 • 7 months
|
|
General disorders
Headache
|
25.0%
1/4 • Number of events 1 • 7 months
|
16.7%
1/6 • Number of events 1 • 7 months
|
16.7%
1/6 • Number of events 1 • 7 months
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/4 • 7 months
|
16.7%
1/6 • Number of events 1 • 7 months
|
0.00%
0/6 • 7 months
|
|
General disorders
Lightheadedness
|
25.0%
1/4 • Number of events 1 • 7 months
|
0.00%
0/6 • 7 months
|
0.00%
0/6 • 7 months
|
Additional Information
Dr. Theo Heller
National Insitute of DIabetes and Digestive and Kidney Diseases
Phone: 301-402-7147
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place