Trial Outcomes & Findings for Efficacy and Safety of MP-424, Interferon Beta (IFN Beta), and Ribavirin(RBV) in Treatment-Naïve or Having Received Interferon Based Therapy With Chronic Hepatitis C (CHC) (NCT NCT01753570)
NCT ID: NCT01753570
Last Updated: 2026-01-06
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
74 participants
Primary outcome timeframe
72 weeks(RBV+IFN beta), 48 weeks(MP-424+RBV+IFN beta)
Results posted on
2026-01-06
Participant Flow
Participant milestones
| Measure |
MP-424+RBV+IFN Beta, Genotype1
Drug: MP-424 MP-424: 750mg every 8 hours (q8h) for 12 weeks Drug: RBV RBV: 600 - 1000 mg/day based on body weight for 24 weeks Drug: IFN beta IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3days /week for 24 weeks
|
RBV+IFN Beta, Genotype1
Drug: RBV RBV: 600 - 1000 mg/day based on body weight for 48 weeks Drug: IFN beta IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3days /week for 48 weeks
|
MP-424+RBV+IFN Beta, Genotype2
Drug: MP-424 MP-424: 750mg every 8 hours (q8h) for 12 weeks Drug: RBV RBV: 600 - 1000 mg/day based on body weight for 24 weeks Drug: IFN beta IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3days /week for 24 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
14
|
|
Overall Study
COMPLETED
|
28
|
25
|
13
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
1
|
Reasons for withdrawal
| Measure |
MP-424+RBV+IFN Beta, Genotype1
Drug: MP-424 MP-424: 750mg every 8 hours (q8h) for 12 weeks Drug: RBV RBV: 600 - 1000 mg/day based on body weight for 24 weeks Drug: IFN beta IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3days /week for 24 weeks
|
RBV+IFN Beta, Genotype1
Drug: RBV RBV: 600 - 1000 mg/day based on body weight for 48 weeks Drug: IFN beta IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3days /week for 48 weeks
|
MP-424+RBV+IFN Beta, Genotype2
Drug: MP-424 MP-424: 750mg every 8 hours (q8h) for 12 weeks Drug: RBV RBV: 600 - 1000 mg/day based on body weight for 24 weeks Drug: IFN beta IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3days /week for 24 weeks
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
4
|
0
|
Baseline Characteristics
Efficacy and Safety of MP-424, Interferon Beta (IFN Beta), and Ribavirin(RBV) in Treatment-Naïve or Having Received Interferon Based Therapy With Chronic Hepatitis C (CHC)
Baseline characteristics by cohort
| Measure |
MP-424+RBV+IFN Beta, Genotype1
n=30 Participants
Drug: MP-424 MP-424: 750mg every 8 hours (q8h) for 12 weeks Drug: RBV RBV: 600 - 1000 mg/day based on body weight for 24 weeks Drug: IFN beta IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3days /week for 24 weeks
|
RBV+IFN Beta, Genotype1
n=30 Participants
Drug: RBV RBV: 600 - 1000 mg/day based on body weight for 48 weeks Drug: IFN beta IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3days /week for 48 weeks
|
MP-424+RBV+IFN Beta, Genotype2
n=14 Participants
Drug: MP-424 MP-424: 750mg every 8 hours (q8h) for 12 weeks Drug: RBV RBV: 600 - 1000 mg/day based on body weight for 24 weeks Drug: IFN beta IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3days /week for 24 weeks
|
Total
n=74 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
60.5 years
STANDARD_DEVIATION 6.4 • n=37 Participants
|
57.6 years
STANDARD_DEVIATION 10.5 • n=56 Participants
|
55.4 years
STANDARD_DEVIATION 7.7 • n=82 Participants
|
58.4 years
STANDARD_DEVIATION 8.7 • n=31 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=37 Participants
|
21 Participants
n=56 Participants
|
9 Participants
n=82 Participants
|
52 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=37 Participants
|
9 Participants
n=56 Participants
|
5 Participants
n=82 Participants
|
22 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 72 weeks(RBV+IFN beta), 48 weeks(MP-424+RBV+IFN beta)Outcome measures
| Measure |
MP-424+RBV+IFN Beta, Genotype1
n=30 Participants
Drug: MP-424 MP-424: 750mg every 8 hours (q8h) for 12 weeks Drug: RBV RBV: 600 - 1000 mg/day based on body weight for 24 weeks Drug: IFN beta IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3days /week for 24 weeks
|
RBV+IFN Beta, Genotype1
n=30 Participants
Drug: RBV RBV: 600 - 1000 mg/day based on body weight for 48 weeks Drug: IFN beta IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3days /week for 48 weeks
|
MP-424+RBV+IFN Beta, Genotype2
n=14 Participants
Drug: MP-424 MP-424: 750mg every 8 hours (q8h) for 12 weeks Drug: RBV RBV: 600 - 1000 mg/day based on body weight for 24 weeks Drug: IFN beta IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3days /week for 24 weeks
|
|---|---|---|---|
|
Undetectable HCV (Hepatitis C Virus) RNA (Ribonucleic Acid) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)
|
63.3 percentage of subjects achieving SVR
Interval 43.9 to 80.1
|
20.0 percentage of subjects achieving SVR
Interval 7.7 to 38.6
|
71.4 percentage of subjects achieving SVR
Interval 41.9 to 91.6
|
SECONDARY outcome
Timeframe: 4 weeksOutcome measures
| Measure |
MP-424+RBV+IFN Beta, Genotype1
n=30 Participants
Drug: MP-424 MP-424: 750mg every 8 hours (q8h) for 12 weeks Drug: RBV RBV: 600 - 1000 mg/day based on body weight for 24 weeks Drug: IFN beta IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3days /week for 24 weeks
|
RBV+IFN Beta, Genotype1
n=30 Participants
Drug: RBV RBV: 600 - 1000 mg/day based on body weight for 48 weeks Drug: IFN beta IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3days /week for 48 weeks
|
MP-424+RBV+IFN Beta, Genotype2
n=14 Participants
Drug: MP-424 MP-424: 750mg every 8 hours (q8h) for 12 weeks Drug: RBV RBV: 600 - 1000 mg/day based on body weight for 24 weeks Drug: IFN beta IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3days /week for 24 weeks
|
|---|---|---|---|
|
Undetectable HCV RNA at 4 Weeks After Beginning of Drug Administration (RVR, Rapid Viral Response)
|
70.0 percentage of subjects achieving RVR
Interval 50.6 to 85.3
|
6.7 percentage of subjects achieving RVR
Interval 0.8 to 22.1
|
92.9 percentage of subjects achieving RVR
Interval 66.1 to 99.8
|
SECONDARY outcome
Timeframe: 48 weeks(RBV+IFN beta), 24 weeks(MP-424+RBV+IFN beta)Outcome measures
| Measure |
MP-424+RBV+IFN Beta, Genotype1
n=30 Participants
Drug: MP-424 MP-424: 750mg every 8 hours (q8h) for 12 weeks Drug: RBV RBV: 600 - 1000 mg/day based on body weight for 24 weeks Drug: IFN beta IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3days /week for 24 weeks
|
RBV+IFN Beta, Genotype1
n=30 Participants
Drug: RBV RBV: 600 - 1000 mg/day based on body weight for 48 weeks Drug: IFN beta IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3days /week for 48 weeks
|
MP-424+RBV+IFN Beta, Genotype2
n=14 Participants
Drug: MP-424 MP-424: 750mg every 8 hours (q8h) for 12 weeks Drug: RBV RBV: 600 - 1000 mg/day based on body weight for 24 weeks Drug: IFN beta IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3days /week for 24 weeks
|
|---|---|---|---|
|
Undetectable HCV RNA at Completion of Drug Administration (ETR, End-of-treatment Response)
|
76.7 percentage of subjects achieving ETR
Interval 57.7 to 90.1
|
30.0 percentage of subjects achieving ETR
Interval 14.7 to 49.4
|
85.7 percentage of subjects achieving ETR
Interval 57.2 to 98.2
|
SECONDARY outcome
Timeframe: 60 weeks(RBV+IFN beta), 36 weeks(MP-424+RBV+IFN beta)Outcome measures
| Measure |
MP-424+RBV+IFN Beta, Genotype1
n=30 Participants
Drug: MP-424 MP-424: 750mg every 8 hours (q8h) for 12 weeks Drug: RBV RBV: 600 - 1000 mg/day based on body weight for 24 weeks Drug: IFN beta IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3days /week for 24 weeks
|
RBV+IFN Beta, Genotype1
n=30 Participants
Drug: RBV RBV: 600 - 1000 mg/day based on body weight for 48 weeks Drug: IFN beta IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3days /week for 48 weeks
|
MP-424+RBV+IFN Beta, Genotype2
n=14 Participants
Drug: MP-424 MP-424: 750mg every 8 hours (q8h) for 12 weeks Drug: RBV RBV: 600 - 1000 mg/day based on body weight for 24 weeks Drug: IFN beta IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3days /week for 24 weeks
|
|---|---|---|---|
|
Undetectable HCV RNA at 12 Weeks After Completion of Drug Administration
|
66.7 percentage of subjects achieving SVR12
Interval 47.2 to 82.7
|
20.0 percentage of subjects achieving SVR12
Interval 7.7 to 38.6
|
71.4 percentage of subjects achieving SVR12
Interval 41.9 to 91.6
|
SECONDARY outcome
Timeframe: Baseline，Day2，Day3，1Week，2Weeks，3Weeks，4Weeks，12Weeks，End of treatment，Follow-up 12weeks，Follow-up 24weeksPopulation: Participants were excluded from analysis because of dropouts or missing data.
Outcome measures
| Measure |
MP-424+RBV+IFN Beta, Genotype1
n=30 Participants
Drug: MP-424 MP-424: 750mg every 8 hours (q8h) for 12 weeks Drug: RBV RBV: 600 - 1000 mg/day based on body weight for 24 weeks Drug: IFN beta IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3days /week for 24 weeks
|
RBV+IFN Beta, Genotype1
n=30 Participants
Drug: RBV RBV: 600 - 1000 mg/day based on body weight for 48 weeks Drug: IFN beta IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3days /week for 48 weeks
|
MP-424+RBV+IFN Beta, Genotype2
n=14 Participants
Drug: MP-424 MP-424: 750mg every 8 hours (q8h) for 12 weeks Drug: RBV RBV: 600 - 1000 mg/day based on body weight for 24 weeks Drug: IFN beta IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3days /week for 24 weeks
|
|---|---|---|---|
|
Transition of Serum HCV RNA Levels
Baseline
|
6.73 log IU/mL
Interval 6.4 to 7.15
|
6.83 log IU/mL
Interval 6.55 to 7.15
|
6.05 log IU/mL
Interval 5.45 to 6.75
|
|
Transition of Serum HCV RNA Levels
Day2
|
4.15 log IU/mL
Interval 3.8 to 4.8
|
5.65 log IU/mL
Interval 5.2 to 6.1
|
3.80 log IU/mL
Interval 3.1 to 4.4
|
|
Transition of Serum HCV RNA Levels
Day3
|
3.35 log IU/mL
Interval 3.0 to 3.6
|
4.85 log IU/mL
Interval 4.4 to 5.3
|
2.80 log IU/mL
Interval 2.3 to 3.3
|
|
Transition of Serum HCV RNA Levels
1Week
|
2.40 log IU/mL
Interval 1.9 to 2.8
|
5.30 log IU/mL
Interval 4.5 to 5.7
|
1.25 log IU/mL
Interval 0.5 to 2.0
|
|
Transition of Serum HCV RNA Levels
2Weeks
|
1.30 log IU/mL
Interval 1.0 to 1.8
|
4.60 log IU/mL
Interval 3.7 to 5.3
|
0.50 log IU/mL
Interval 0.5 to 1.4
|
|
Transition of Serum HCV RNA Levels
3Weeks
|
0.50 log IU/mL
Interval 0.5 to 1.0
|
3.70 log IU/mL
Interval 2.9 to 4.8
|
0.50 log IU/mL
Interval 0.5 to 0.5
|
|
Transition of Serum HCV RNA Levels
4Weeks
|
0.50 log IU/mL
Interval 0.5 to 0.75
|
3.20 log IU/mL
Interval 2.0 to 4.2
|
0.50 log IU/mL
Interval 0.5 to 0.5
|
|
Transition of Serum HCV RNA Levels
12Weeks
|
0.50 log IU/mL
Interval 0.5 to 0.5
|
2.75 log IU/mL
Interval 0.5 to 4.75
|
0.50 log IU/mL
Interval 0.5 to 0.5
|
|
Transition of Serum HCV RNA Levels
End of treatment
|
0.50 log IU/mL
Interval 0.5 to 0.5
|
3.20 log IU/mL
Interval 0.5 to 5.6
|
0.50 log IU/mL
Interval 0.5 to 0.5
|
|
Transition of Serum HCV RNA Levels
Follow-up 12weeks
|
0.50 log IU/mL
Interval 0.5 to 6.0
|
6.20 log IU/mL
Interval 5.0 to 6.7
|
0.50 log IU/mL
Interval 0.5 to 0.5
|
|
Transition of Serum HCV RNA Levels
Follow-up 24weeks
|
0.50 log IU/mL
Interval 0.5 to 6.6
|
6.20 log IU/mL
Interval 5.4 to 6.8
|
0.50 log IU/mL
Interval 0.5 to 0.5
|
SECONDARY outcome
Timeframe: From baseline to 24 weeks after completion of drug administrationPopulation: "Overall number of participants analyzed" indicates the number of participants who did not achieve SVR and detected HCV RNA as positive at the last visit in each group, MP-424+RBV+IFN Beta, Genotype1 and MP-424+RBV+IFN Beta, Genotype2.
To examine the emergence of resistance-associated variants after MP-424 administration.
Outcome measures
| Measure |
MP-424+RBV+IFN Beta, Genotype1
n=8 Participants
Drug: MP-424 MP-424: 750mg every 8 hours (q8h) for 12 weeks Drug: RBV RBV: 600 - 1000 mg/day based on body weight for 24 weeks Drug: IFN beta IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3days /week for 24 weeks
|
RBV+IFN Beta, Genotype1
n=2 Participants
Drug: RBV RBV: 600 - 1000 mg/day based on body weight for 48 weeks Drug: IFN beta IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3days /week for 48 weeks
|
MP-424+RBV+IFN Beta, Genotype2
Drug: MP-424 MP-424: 750mg every 8 hours (q8h) for 12 weeks Drug: RBV RBV: 600 - 1000 mg/day based on body weight for 24 weeks Drug: IFN beta IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3days /week for 24 weeks
|
|---|---|---|---|
|
Number of Participants With the Emergence of Resistance-associated Variants After MP-424 Administration at the Non-structural 3 Protease Region of HCV.
T54S，A156T，V36A
|
1 participants
|
0 participants
|
—
|
|
Number of Participants With the Emergence of Resistance-associated Variants After MP-424 Administration at the Non-structural 3 Protease Region of HCV.
T54A，R155W
|
0 participants
|
1 participants
|
—
|
|
Number of Participants With the Emergence of Resistance-associated Variants After MP-424 Administration at the Non-structural 3 Protease Region of HCV.
Not detected
|
5 participants
|
1 participants
|
—
|
|
Number of Participants With the Emergence of Resistance-associated Variants After MP-424 Administration at the Non-structural 3 Protease Region of HCV.
V36M
|
1 participants
|
0 participants
|
—
|
|
Number of Participants With the Emergence of Resistance-associated Variants After MP-424 Administration at the Non-structural 3 Protease Region of HCV.
T54A
|
1 participants
|
0 participants
|
—
|
Adverse Events
MP-424+RBV+IFN Beta, Genotype1
Serious events: 4 serious events
Other events: 30 other events
Deaths: 0 deaths
RBV+IFN Beta, Genotype1
Serious events: 3 serious events
Other events: 30 other events
Deaths: 0 deaths
MP-424+RBV+IFN Beta, Genotype2
Serious events: 5 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MP-424+RBV+IFN Beta, Genotype1
n=30 participants at risk
"Drug: MP-424 MP-424: 750mg every 8 hours (q8h) for 12 weeks Drug: RBV RBV: 600 - 1000 mg/day based on body weight for 24 weeks Drug: IFN beta IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3days /week for 24 weeks
|
RBV+IFN Beta, Genotype1
n=30 participants at risk
"Drug: RBV RBV: 600 - 1000 mg/day based on body weight for 48 weeks Drug: IFN beta IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3days /week for 48 weeks
|
MP-424+RBV+IFN Beta, Genotype2
n=14 participants at risk
"Drug: MP-424 MP-424: 750mg every 8 hours (q8h) for 12 weeks Drug: RBV RBV: 600 - 1000 mg/day based on body weight for 24 weeks Drug: IFN beta IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3days /week for 24 weeks
|
|---|---|---|---|
|
Infections and infestations
Pneumonia
|
3.3%
1/30
|
0.00%
0/30
|
0.00%
0/14
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/30
|
3.3%
1/30
|
0.00%
0/14
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
3.3%
1/30
|
0.00%
0/30
|
0.00%
0/14
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/30
|
3.3%
1/30
|
0.00%
0/14
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.00%
0/30
|
0.00%
0/30
|
7.1%
1/14
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/30
|
0.00%
0/30
|
7.1%
1/14
|
|
Eye disorders
Cataract
|
0.00%
0/30
|
0.00%
0/30
|
7.1%
1/14
|
|
Eye disorders
Optic nerve disorder
|
0.00%
0/30
|
0.00%
0/30
|
7.1%
1/14
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.00%
0/30
|
3.3%
1/30
|
0.00%
0/14
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
3.3%
1/30
|
0.00%
0/30
|
0.00%
0/14
|
|
Hepatobiliary disorders
Cholangitis
|
3.3%
1/30
|
0.00%
0/30
|
0.00%
0/14
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/30
|
0.00%
0/30
|
7.1%
1/14
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/30
|
0.00%
0/30
|
7.1%
1/14
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/30
|
0.00%
0/30
|
7.1%
1/14
|
Other adverse events
| Measure |
MP-424+RBV+IFN Beta, Genotype1
n=30 participants at risk
"Drug: MP-424 MP-424: 750mg every 8 hours (q8h) for 12 weeks Drug: RBV RBV: 600 - 1000 mg/day based on body weight for 24 weeks Drug: IFN beta IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3days /week for 24 weeks
|
RBV+IFN Beta, Genotype1
n=30 participants at risk
"Drug: RBV RBV: 600 - 1000 mg/day based on body weight for 48 weeks Drug: IFN beta IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3days /week for 48 weeks
|
MP-424+RBV+IFN Beta, Genotype2
n=14 participants at risk
"Drug: MP-424 MP-424: 750mg every 8 hours (q8h) for 12 weeks Drug: RBV RBV: 600 - 1000 mg/day based on body weight for 24 weeks Drug: IFN beta IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3days /week for 24 weeks
|
|---|---|---|---|
|
Infections and infestations
Acne pustular
|
0.00%
0/30
|
0.00%
0/30
|
7.1%
1/14
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/30
|
0.00%
0/30
|
7.1%
1/14
|
|
Infections and infestations
Eczema impetiginous
|
0.00%
0/30
|
0.00%
0/30
|
7.1%
1/14
|
|
Infections and infestations
Enteritis infectious
|
0.00%
0/30
|
0.00%
0/30
|
7.1%
1/14
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/30
|
0.00%
0/30
|
7.1%
1/14
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal tract adenoma
|
0.00%
0/30
|
0.00%
0/30
|
7.1%
1/14
|
|
Blood and lymphatic system disorders
Anaemia
|
83.3%
25/30
|
56.7%
17/30
|
78.6%
11/14
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
23.3%
7/30
|
3.3%
1/30
|
14.3%
2/14
|
|
Metabolism and nutrition disorders
Decreased appetite
|
20.0%
6/30
|
6.7%
2/30
|
28.6%
4/14
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.7%
2/30
|
0.00%
0/30
|
14.3%
2/14
|
|
Psychiatric disorders
Insomnia
|
26.7%
8/30
|
20.0%
6/30
|
42.9%
6/14
|
|
Psychiatric disorders
Depression
|
3.3%
1/30
|
10.0%
3/30
|
7.1%
1/14
|
|
Psychiatric disorders
Abulia
|
0.00%
0/30
|
0.00%
0/30
|
7.1%
1/14
|
|
Nervous system disorders
Headache
|
46.7%
14/30
|
50.0%
15/30
|
42.9%
6/14
|
|
Nervous system disorders
Dizziness
|
3.3%
1/30
|
13.3%
4/30
|
14.3%
2/14
|
|
Nervous system disorders
Dysgeusia
|
3.3%
1/30
|
0.00%
0/30
|
14.3%
2/14
|
|
Nervous system disorders
Tension headache
|
0.00%
0/30
|
6.7%
2/30
|
0.00%
0/14
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.00%
0/30
|
0.00%
0/30
|
7.1%
1/14
|
|
Eye disorders
Pingueculitis
|
0.00%
0/30
|
0.00%
0/30
|
7.1%
1/14
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/30
|
0.00%
0/30
|
7.1%
1/14
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
2/30
|
3.3%
1/30
|
0.00%
0/14
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
6.7%
2/30
|
3.3%
1/30
|
0.00%
0/14
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.7%
2/30
|
3.3%
1/30
|
0.00%
0/14
|
|
Gastrointestinal disorders
Nausea
|
40.0%
12/30
|
20.0%
6/30
|
28.6%
4/14
|
|
Gastrointestinal disorders
Diarrhoea
|
20.0%
6/30
|
13.3%
4/30
|
14.3%
2/14
|
|
Gastrointestinal disorders
Vomiting
|
13.3%
4/30
|
20.0%
6/30
|
28.6%
4/14
|
|
Gastrointestinal disorders
Constipation
|
13.3%
4/30
|
20.0%
6/30
|
14.3%
2/14
|
|
Gastrointestinal disorders
Stomatitis
|
13.3%
4/30
|
16.7%
5/30
|
0.00%
0/14
|
|
Gastrointestinal disorders
Abdominal discomfort
|
13.3%
4/30
|
10.0%
3/30
|
28.6%
4/14
|
|
Gastrointestinal disorders
Gastritis
|
6.7%
2/30
|
10.0%
3/30
|
0.00%
0/14
|
|
Gastrointestinal disorders
Cheilitis
|
6.7%
2/30
|
0.00%
0/30
|
7.1%
1/14
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.7%
2/30
|
0.00%
0/30
|
0.00%
0/14
|
|
Gastrointestinal disorders
Faeces soft
|
3.3%
1/30
|
3.3%
1/30
|
7.1%
1/14
|
|
Gastrointestinal disorders
Dental caries
|
3.3%
1/30
|
0.00%
0/30
|
21.4%
3/14
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/30
|
6.7%
2/30
|
0.00%
0/14
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/30
|
0.00%
0/30
|
7.1%
1/14
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/30
|
0.00%
0/30
|
7.1%
1/14
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/30
|
0.00%
0/30
|
7.1%
1/14
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/30
|
0.00%
0/30
|
7.1%
1/14
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
6.7%
2/30
|
0.00%
0/30
|
0.00%
0/14
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/30
|
0.00%
0/30
|
7.1%
1/14
|
|
Skin and subcutaneous tissue disorders
Rash
|
43.3%
13/30
|
16.7%
5/30
|
50.0%
7/14
|
|
Infections and infestations
Nasopharyngitis
|
26.7%
8/30
|
40.0%
12/30
|
28.6%
4/14
|
|
Infections and infestations
Cystitis
|
10.0%
3/30
|
3.3%
1/30
|
21.4%
3/14
|
|
Infections and infestations
Oral herpes
|
6.7%
2/30
|
3.3%
1/30
|
7.1%
1/14
|
|
Infections and infestations
Pharyngitis
|
3.3%
1/30
|
13.3%
4/30
|
0.00%
0/14
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/30
|
10.0%
3/30
|
0.00%
0/14
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/30
|
6.7%
2/30
|
7.1%
1/14
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/30
|
6.7%
2/30
|
0.00%
0/14
|
|
Infections and infestations
Bronchitis
|
0.00%
0/30
|
3.3%
1/30
|
7.1%
1/14
|
|
Infections and infestations
Folliculitis
|
0.00%
0/30
|
3.3%
1/30
|
7.1%
1/14
|
|
Infections and infestations
Otitis externa
|
0.00%
0/30
|
3.3%
1/30
|
7.1%
1/14
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/30
|
3.3%
1/30
|
7.1%
1/14
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
26.7%
8/30
|
26.7%
8/30
|
14.3%
2/14
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
16.7%
5/30
|
0.00%
0/30
|
35.7%
5/14
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
10.0%
3/30
|
3.3%
1/30
|
7.1%
1/14
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
6.7%
2/30
|
0.00%
0/30
|
14.3%
2/14
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
3.3%
1/30
|
13.3%
4/30
|
7.1%
1/14
|
|
Skin and subcutaneous tissue disorders
Eczema
|
3.3%
1/30
|
13.3%
4/30
|
0.00%
0/14
|
|
Skin and subcutaneous tissue disorders
Acne
|
3.3%
1/30
|
3.3%
1/30
|
7.1%
1/14
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
3.3%
1/30
|
0.00%
0/30
|
14.3%
2/14
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
0.00%
0/30
|
6.7%
2/30
|
7.1%
1/14
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/30
|
3.3%
1/30
|
7.1%
1/14
|
|
Skin and subcutaneous tissue disorders
Dyshidrotic eczema
|
0.00%
0/30
|
0.00%
0/30
|
14.3%
2/14
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/30
|
0.00%
0/30
|
7.1%
1/14
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
23.3%
7/30
|
33.3%
10/30
|
21.4%
3/14
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
5/30
|
6.7%
2/30
|
14.3%
2/14
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
13.3%
4/30
|
3.3%
1/30
|
14.3%
2/14
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/30
|
6.7%
2/30
|
7.1%
1/14
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/30
|
0.00%
0/30
|
14.3%
2/14
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/30
|
0.00%
0/30
|
7.1%
1/14
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/30
|
0.00%
0/30
|
7.1%
1/14
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/30
|
0.00%
0/30
|
7.1%
1/14
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/30
|
0.00%
0/30
|
7.1%
1/14
|
|
Renal and urinary disorders
Renal impairment
|
10.0%
3/30
|
0.00%
0/30
|
0.00%
0/14
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/30
|
3.3%
1/30
|
7.1%
1/14
|
|
Renal and urinary disorders
Renal disorder
|
0.00%
0/30
|
0.00%
0/30
|
7.1%
1/14
|
|
Renal and urinary disorders
Urine abnormality
|
0.00%
0/30
|
0.00%
0/30
|
7.1%
1/14
|
|
General disorders
Pyrexia
|
73.3%
22/30
|
86.7%
26/30
|
100.0%
14/14
|
|
General disorders
Malaise
|
60.0%
18/30
|
46.7%
14/30
|
50.0%
7/14
|
|
General disorders
Chills
|
3.3%
1/30
|
0.00%
0/30
|
7.1%
1/14
|
|
General disorders
Oedema
|
3.3%
1/30
|
0.00%
0/30
|
7.1%
1/14
|
|
General disorders
Oedema peripheral
|
3.3%
1/30
|
0.00%
0/30
|
7.1%
1/14
|
|
General disorders
Chest pain
|
0.00%
0/30
|
0.00%
0/30
|
7.1%
1/14
|
|
Investigations
Blood uric acid increased
|
43.3%
13/30
|
16.7%
5/30
|
71.4%
10/14
|
|
Investigations
Blood creatinine increased
|
40.0%
12/30
|
0.00%
0/30
|
35.7%
5/14
|
|
Investigations
Platelet count decreased
|
20.0%
6/30
|
36.7%
11/30
|
28.6%
4/14
|
|
Investigations
Hyaluronic acid increased
|
16.7%
5/30
|
3.3%
1/30
|
14.3%
2/14
|
|
Investigations
Blood bilirubin increased
|
13.3%
4/30
|
6.7%
2/30
|
21.4%
3/14
|
|
Investigations
Blood triglycerides increased
|
13.3%
4/30
|
6.7%
2/30
|
7.1%
1/14
|
|
Investigations
White blood cell count decreased
|
10.0%
3/30
|
40.0%
12/30
|
35.7%
5/14
|
|
Investigations
Haemoglobin decreased
|
10.0%
3/30
|
10.0%
3/30
|
7.1%
1/14
|
|
Investigations
Neutrophil count decreased
|
6.7%
2/30
|
30.0%
9/30
|
7.1%
1/14
|
|
Investigations
Protein urine present
|
6.7%
2/30
|
13.3%
4/30
|
7.1%
1/14
|
|
Investigations
Alanine aminotransferase increased
|
6.7%
2/30
|
6.7%
2/30
|
7.1%
1/14
|
|
Investigations
Aspartate aminotransferase increased
|
6.7%
2/30
|
6.7%
2/30
|
7.1%
1/14
|
|
Investigations
Haematocrit decreased
|
6.7%
2/30
|
0.00%
0/30
|
0.00%
0/14
|
|
Investigations
Red blood cell count decreased
|
6.7%
2/30
|
0.00%
0/30
|
0.00%
0/14
|
|
Investigations
Collagen antigen type IV increased
|
6.7%
2/30
|
0.00%
0/30
|
0.00%
0/14
|
|
Investigations
Blood albumin decreased
|
3.3%
1/30
|
3.3%
1/30
|
7.1%
1/14
|
|
Investigations
Liver function test abnormal
|
3.3%
1/30
|
3.3%
1/30
|
7.1%
1/14
|
|
Investigations
C-reactive protein increased
|
3.3%
1/30
|
0.00%
0/30
|
7.1%
1/14
|
|
Investigations
Glucose urine present
|
0.00%
0/30
|
3.3%
1/30
|
7.1%
1/14
|
|
Investigations
Blood chloride decreased
|
0.00%
0/30
|
0.00%
0/30
|
7.1%
1/14
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/30
|
0.00%
0/30
|
7.1%
1/14
|
|
Investigations
Blood glucose increased
|
0.00%
0/30
|
0.00%
0/30
|
7.1%
1/14
|
|
Investigations
Blood pressure increased
|
0.00%
0/30
|
0.00%
0/30
|
7.1%
1/14
|
|
Investigations
Blood sodium decreased
|
0.00%
0/30
|
0.00%
0/30
|
7.1%
1/14
|
|
Investigations
Blood urea increased
|
0.00%
0/30
|
0.00%
0/30
|
7.1%
1/14
|
|
Investigations
Eosinophil count increased
|
0.00%
0/30
|
0.00%
0/30
|
7.1%
1/14
|
|
Investigations
Blood urine present
|
0.00%
0/30
|
0.00%
0/30
|
7.1%
1/14
|
|
Investigations
Thyroid function test abnormal
|
0.00%
0/30
|
0.00%
0/30
|
7.1%
1/14
|
|
Investigations
White blood cell count increased
|
0.00%
0/30
|
0.00%
0/30
|
7.1%
1/14
|
|
Investigations
White blood cells urine positive
|
0.00%
0/30
|
0.00%
0/30
|
7.1%
1/14
|
|
Investigations
Neutrophil percentage increased
|
0.00%
0/30
|
0.00%
0/30
|
7.1%
1/14
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
6.7%
2/30
|
3.3%
1/30
|
7.1%
1/14
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
3.3%
1/30
|
3.3%
1/30
|
7.1%
1/14
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/30
|
10.0%
3/30
|
7.1%
1/14
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/30
|
0.00%
0/30
|
7.1%
1/14
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER