Trial Outcomes & Findings for Anticoagulation in Liver Fibrosis in Patients With Hepatitis C Virus Infection (NCT NCT00180674)
NCT ID: NCT00180674
Last Updated: 2020-12-01
Results Overview
Median liver stiffness at 16-weeks following the 8-week period of anticoagulation, compared to 8-week period of observation. kPa values reported are the values from completion of the period of anticoagulation at week 16 versus completion of the observation period at week 8, and start of the observation period at week 0.
COMPLETED
PHASE2
14 participants
Baseline (start of the observation period at week 0), 8-weeks (completion of the observation period) and 16-weeks (completion of the period of anticoagulation)
2020-12-01
Participant Flow
A total of 14 patients were enrolled in the study. Ten patients completed the study. Four patients withdrew from the study, all during the Phase 1 Observation Period due to personal reasons. These 4 patients did not participate in Phase 2, Treatment Period and they are not included in the analyses.
Participant milestones
| Measure |
Warfarin Anticoagulation
Anticoagulated with warfarin to maintain an INR of 2-3 between 8 and 16 weeks (Phase 2, Treatment Period).
|
|---|---|
|
Phase 1, Observation Period
STARTED
|
14
|
|
Phase 1, Observation Period
COMPLETED
|
10
|
|
Phase 1, Observation Period
NOT COMPLETED
|
4
|
|
Phase 2, Warfarin Treatment Period
STARTED
|
10
|
|
Phase 2, Warfarin Treatment Period
COMPLETED
|
9
|
|
Phase 2, Warfarin Treatment Period
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Warfarin Anticoagulation
Anticoagulated with warfarin to maintain an INR of 2-3 between 8 and 16 weeks (Phase 2, Treatment Period).
|
|---|---|
|
Phase 1, Observation Period
Withdrawal by Subject
|
4
|
|
Phase 2, Warfarin Treatment Period
Adverse Event
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Warfarin Anticoagulation
n=10 Participants
Anticoagulated with warfarin to maintain an INR of 2-3 between 8 and 16 weeks (Phase 2, Treatment Period).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=10 Participants
|
|
Age, Continuous
|
49.5 years
n=10 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=10 Participants
|
|
Region of Enrollment
United Kingdom
|
10 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Baseline (start of the observation period at week 0), 8-weeks (completion of the observation period) and 16-weeks (completion of the period of anticoagulation)Population: One participant excluded from Phase 2, Warfarin Anticoagulation Period due to a non serious adverse event.
Median liver stiffness at 16-weeks following the 8-week period of anticoagulation, compared to 8-week period of observation. kPa values reported are the values from completion of the period of anticoagulation at week 16 versus completion of the observation period at week 8, and start of the observation period at week 0.
Outcome measures
| Measure |
Observation Period
n=10 Participants
Phase 1, Observation Period Observation period began at Week 0 and was completed at Week 8.
|
Warfarin Anticoagulation
n=9 Participants
Phase 2, Treatment Period Anticoagulated with warfarin to maintain an INR of 2-3 between 8 and 16 weeks (treatment period).
|
|---|---|---|
|
Median Liver Stiffness Value
|
7.70 kPa
The PI has left the institution and we have exhausted all efforts to locate this data. No data is available and therefore cannot be reported.
|
6.90 kPa
The PI has left the institution and we have exhausted all efforts to locate this data. No data is available and therefore cannot be reported.
|
SECONDARY outcome
Timeframe: 8-week period of warfarin treatment and 8-week observation period (16 weeks)The secondary endpoints were the proportion of patients with a reduction in serum markers of fibrosis and HTTs following the 8-week period of anticoagulation compared to the 8-week period of observation and the safety of anticoagulation defined by the number of adverse events.
Outcome measures
| Measure |
Observation Period
n=10 Participants
Phase 1, Observation Period Observation period began at Week 0 and was completed at Week 8.
|
Warfarin Anticoagulation
n=9 Participants
Phase 2, Treatment Period Anticoagulated with warfarin to maintain an INR of 2-3 between 8 and 16 weeks (treatment period).
|
|---|---|---|
|
Number of Participants With Adverse Events
|
0 Participants
|
1 Participants
|
Adverse Events
Observation Period (Phase 1)
Warfarin Anticoagulation (Phase 2
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Observation Period (Phase 1)
n=10 participants at risk
Phase 1, Observation Period Phase 1 of the study consisted of 8 weeks of observation, which commenced following a baseline visit at week 0.
|
Warfarin Anticoagulation (Phase 2
n=9 participants at risk
Phase 2, Treatment Period Anticoagulated with warfarin to maintain an INR of 2-3 between 8 and 16 weeks (treatment period).
A single adverse event was noted in one subject during the anticoagulation period. This was classed as minor in severity and related to an episode of minor haemorrhage secondary to an episode of gingivitis, which resolved following antibiotics and did not require blood transfusion, but did require cessation of the anticoagulation for a short period of 2 days. This patient was not included in the analysis. No other subjects required cessation of treatment during the anticoagulation period.
|
|---|---|---|
|
General disorders
Minor haemorrhage
|
0.00%
0/10 • 16 weeks
|
11.1%
1/9 • Number of events 1 • 16 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place