Trial Outcomes & Findings for Vancomycin for Primary Sclerosing Cholangitis (NCT NCT03710122)
NCT ID: NCT03710122
Last Updated: 2026-04-22
Results Overview
Determine if OV normalizes serum ALP in adults with PSC. Levels of serum ALP obtained at 6 months of OV treatment, and will be compared to those obtained at baseline (month 0), and with values at the same study time points in the placebo arm.
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
102 participants
Primary outcome timeframe
6 months
Results posted on
2026-04-22
Participant Flow
82 patients randomized
Participant milestones
| Measure |
Vancomycin
Treatment arm
|
Placebo
Control arm
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
42
|
|
Overall Study
Completed 6 months
|
24
|
36
|
|
Overall Study
Completed 12 months
|
19
|
25
|
|
Overall Study
Completed 18 months
|
15
|
20
|
|
Overall Study
COMPLETED
|
15
|
20
|
|
Overall Study
NOT COMPLETED
|
25
|
22
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Vancomycin
n=40 Participants
Treatment arm
|
Placebo
n=42 Participants
Control arm
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43 years
n=40 Participants
|
42.5 years
n=42 Participants
|
42.5 years
n=82 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=40 Participants
|
21 Participants
n=42 Participants
|
40 Participants
n=82 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=40 Participants
|
21 Participants
n=42 Participants
|
42 Participants
n=82 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 6 monthsDetermine if OV normalizes serum ALP in adults with PSC. Levels of serum ALP obtained at 6 months of OV treatment, and will be compared to those obtained at baseline (month 0), and with values at the same study time points in the placebo arm.
Outcome measures
| Measure |
Vancomycin
n=24 Participants
Treatment arm
|
Placebo
n=36 Participants
Control arm
|
|---|---|---|
|
Alkaline Phosphatase at 6 Months
|
351 U/L
Interval 275.0 to 407.0
|
355 U/L
Interval 300.0 to 410.0
|
PRIMARY outcome
Timeframe: 12 monthsDetermine if OV normalizes serum ALP in adults with PSC. Levels of serum ALP obtained at 12 months of OV treatment, and will be compared to those obtained at baseline (month 0), and with values at the same study time points in the placebo arm.
Outcome measures
| Measure |
Vancomycin
n=19 Participants
Treatment arm
|
Placebo
n=25 Participants
Control arm
|
|---|---|---|
|
Alkaline Phosphatase at 12 Months
|
280 U/L
Interval 210.0 to 356.0
|
354 U/L
Interval 280.0 to 415.0
|
PRIMARY outcome
Timeframe: 18 monthsDetermine if OV normalizes serum ALP in adults with PSC. Levels of serum ALP obtained at 18 months of OV treatment, and will be compared to those obtained at baseline (month 0), and with values at the same study time points in the placebo arm.
Outcome measures
| Measure |
Vancomycin
n=15 Participants
Treatment arm
|
Placebo
n=20 Participants
Control arm
|
|---|---|---|
|
Alkaline Phosphatase at 18 Months
|
304 U/L
Interval 255.0 to 311.0
|
311 U/L
Interval 304.0 to 446.0
|
PRIMARY outcome
Timeframe: 21 monthsTo determine if there is a change in alkaline phosphatase 3 months after study treatment completed
Outcome measures
| Measure |
Vancomycin
n=12 Participants
Treatment arm
|
Placebo
n=16 Participants
Control arm
|
|---|---|---|
|
Alkaline Phosphatase at 21 Months
|
349.5 U/L
Standard Deviation 160.9
|
320.5 U/L
Standard Deviation 159.7
|
PRIMARY outcome
Timeframe: 24 monthsTo determine if there is a change in alkaline phosphatase 6 months after stopping study treatment
Outcome measures
| Measure |
Vancomycin
n=17 Participants
Treatment arm
|
Placebo
n=23 Participants
Control arm
|
|---|---|---|
|
Alkaline Phosphatase at 24 Months
|
294.6 U/L
Standard Deviation 119.5
|
262.4 U/L
Standard Deviation 123.5
|
SECONDARY outcome
Timeframe: 18 monthsStatistically significant reduction in liver stiffness measurement (kPa)
Outcome measures
| Measure |
Vancomycin
n=15 Participants
Treatment arm
|
Placebo
n=18 Participants
Control arm
|
|---|---|---|
|
Number of Participants With Reduction in Liver Stiffness
|
4 Participants
|
2 Participants
|
Adverse Events
Vancomycin
Serious events: 5 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo
Serious events: 7 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vancomycin
n=40 participants at risk
Treatment Arm Adverse Events to End of Treatment (18 months)
|
Placebo
n=42 participants at risk
Control arm Adverse Events to End of Treatment (18 months)
|
|---|---|---|
|
Hepatobiliary disorders
Cholangitis
|
5.0%
2/40 • Adverse events were monitored by patient contact every 3 months with the study coordinator and physician visits every 6 months from the time of enrolment until the end of follow-up (24 months). Additionally, patients were instructed to contact the study coordinator immediately when adverse events occurred.
|
7.1%
3/42 • Adverse events were monitored by patient contact every 3 months with the study coordinator and physician visits every 6 months from the time of enrolment until the end of follow-up (24 months). Additionally, patients were instructed to contact the study coordinator immediately when adverse events occurred.
|
|
General disorders
Other
|
7.5%
3/40 • Adverse events were monitored by patient contact every 3 months with the study coordinator and physician visits every 6 months from the time of enrolment until the end of follow-up (24 months). Additionally, patients were instructed to contact the study coordinator immediately when adverse events occurred.
|
9.5%
4/42 • Adverse events were monitored by patient contact every 3 months with the study coordinator and physician visits every 6 months from the time of enrolment until the end of follow-up (24 months). Additionally, patients were instructed to contact the study coordinator immediately when adverse events occurred.
|
Other adverse events
| Measure |
Vancomycin
n=40 participants at risk
Treatment Arm Adverse Events to End of Treatment (18 months)
|
Placebo
n=42 participants at risk
Control arm Adverse Events to End of Treatment (18 months)
|
|---|---|---|
|
General disorders
Discoloration of teeth
|
17.5%
7/40 • Adverse events were monitored by patient contact every 3 months with the study coordinator and physician visits every 6 months from the time of enrolment until the end of follow-up (24 months). Additionally, patients were instructed to contact the study coordinator immediately when adverse events occurred.
|
0.00%
0/42 • Adverse events were monitored by patient contact every 3 months with the study coordinator and physician visits every 6 months from the time of enrolment until the end of follow-up (24 months). Additionally, patients were instructed to contact the study coordinator immediately when adverse events occurred.
|
|
General disorders
Fatigue
|
20.0%
8/40 • Adverse events were monitored by patient contact every 3 months with the study coordinator and physician visits every 6 months from the time of enrolment until the end of follow-up (24 months). Additionally, patients were instructed to contact the study coordinator immediately when adverse events occurred.
|
7.1%
3/42 • Adverse events were monitored by patient contact every 3 months with the study coordinator and physician visits every 6 months from the time of enrolment until the end of follow-up (24 months). Additionally, patients were instructed to contact the study coordinator immediately when adverse events occurred.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
15.0%
6/40 • Adverse events were monitored by patient contact every 3 months with the study coordinator and physician visits every 6 months from the time of enrolment until the end of follow-up (24 months). Additionally, patients were instructed to contact the study coordinator immediately when adverse events occurred.
|
28.6%
12/42 • Adverse events were monitored by patient contact every 3 months with the study coordinator and physician visits every 6 months from the time of enrolment until the end of follow-up (24 months). Additionally, patients were instructed to contact the study coordinator immediately when adverse events occurred.
|
|
Gastrointestinal disorders
Loose Stool
|
17.5%
7/40 • Adverse events were monitored by patient contact every 3 months with the study coordinator and physician visits every 6 months from the time of enrolment until the end of follow-up (24 months). Additionally, patients were instructed to contact the study coordinator immediately when adverse events occurred.
|
21.4%
9/42 • Adverse events were monitored by patient contact every 3 months with the study coordinator and physician visits every 6 months from the time of enrolment until the end of follow-up (24 months). Additionally, patients were instructed to contact the study coordinator immediately when adverse events occurred.
|
|
Infections and infestations
COVID
|
7.5%
3/40 • Adverse events were monitored by patient contact every 3 months with the study coordinator and physician visits every 6 months from the time of enrolment until the end of follow-up (24 months). Additionally, patients were instructed to contact the study coordinator immediately when adverse events occurred.
|
14.3%
6/42 • Adverse events were monitored by patient contact every 3 months with the study coordinator and physician visits every 6 months from the time of enrolment until the end of follow-up (24 months). Additionally, patients were instructed to contact the study coordinator immediately when adverse events occurred.
|
|
Gastrointestinal disorders
Abdominal pain
|
17.5%
7/40 • Adverse events were monitored by patient contact every 3 months with the study coordinator and physician visits every 6 months from the time of enrolment until the end of follow-up (24 months). Additionally, patients were instructed to contact the study coordinator immediately when adverse events occurred.
|
21.4%
9/42 • Adverse events were monitored by patient contact every 3 months with the study coordinator and physician visits every 6 months from the time of enrolment until the end of follow-up (24 months). Additionally, patients were instructed to contact the study coordinator immediately when adverse events occurred.
|
|
Musculoskeletal and connective tissue disorders
Muscle pain
|
15.0%
6/40 • Adverse events were monitored by patient contact every 3 months with the study coordinator and physician visits every 6 months from the time of enrolment until the end of follow-up (24 months). Additionally, patients were instructed to contact the study coordinator immediately when adverse events occurred.
|
19.0%
8/42 • Adverse events were monitored by patient contact every 3 months with the study coordinator and physician visits every 6 months from the time of enrolment until the end of follow-up (24 months). Additionally, patients were instructed to contact the study coordinator immediately when adverse events occurred.
|
|
Infections and infestations
URI
|
2.5%
1/40 • Adverse events were monitored by patient contact every 3 months with the study coordinator and physician visits every 6 months from the time of enrolment until the end of follow-up (24 months). Additionally, patients were instructed to contact the study coordinator immediately when adverse events occurred.
|
14.3%
6/42 • Adverse events were monitored by patient contact every 3 months with the study coordinator and physician visits every 6 months from the time of enrolment until the end of follow-up (24 months). Additionally, patients were instructed to contact the study coordinator immediately when adverse events occurred.
|
|
Gastrointestinal disorders
Elevated liver tests
|
15.0%
6/40 • Adverse events were monitored by patient contact every 3 months with the study coordinator and physician visits every 6 months from the time of enrolment until the end of follow-up (24 months). Additionally, patients were instructed to contact the study coordinator immediately when adverse events occurred.
|
9.5%
4/42 • Adverse events were monitored by patient contact every 3 months with the study coordinator and physician visits every 6 months from the time of enrolment until the end of follow-up (24 months). Additionally, patients were instructed to contact the study coordinator immediately when adverse events occurred.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place