Trial Outcomes & Findings for Evaluate the Efficacy and Safety of TG-2349 in Subjects With Hepatitis C Infection (NCT NCT02340962)
NCT ID: NCT02340962
Last Updated: 2023-07-14
Results Overview
Proportion of subjects with HCV RNA\< LLOQ (lower limit of quantification), TD (target detected) or TND (target not detected) at 12 weeks after the end of treatment (SVR12) in the Full Analysis Set (FAS) population, which include subjects with genotype 1b HCV infection who were enrolled and received at least one dose of study drugs.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
12 weeks after the end of treatment (SVR12), after 12-week treatments
Results posted on
2023-07-14
Participant Flow
Participant milestones
| Measure |
200 mg TG-2349
200 mg TG-2349 (2 capsules) + Interferon or Peg-interferon + Ribavirin
|
400 mg TG-2349
400 mg TG-2349 (4 capsules) + Interferon or Peg-interferon + Ribavirin
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
200 mg TG-2349
200 mg TG-2349 (2 capsules) + Interferon or Peg-interferon + Ribavirin
|
400 mg TG-2349
400 mg TG-2349 (4 capsules) + Interferon or Peg-interferon + Ribavirin
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Evaluate the Efficacy and Safety of TG-2349 in Subjects With Hepatitis C Infection
Baseline characteristics by cohort
| Measure |
200 mg TG-2349
n=13 Participants
200 mg TG-2349 (2 capsules) + Interferon or Peg-interferon + Ribavirin
|
400 mg TG-2349
n=12 Participants
400 mg TG-2349 (4 capsules) + Interferon or Peg-interferon + Ribavirin
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.8 years
STANDARD_DEVIATION 10.76 • n=5 Participants
|
54.0 years
STANDARD_DEVIATION 11.91 • n=7 Participants
|
52.3 years
STANDARD_DEVIATION 11.21 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Weight
|
62.8 kilogram
STANDARD_DEVIATION 13.69 • n=5 Participants
|
64.0 kilogram
STANDARD_DEVIATION 9.11 • n=7 Participants
|
63.4 kilogram
STANDARD_DEVIATION 11.49 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeks after the end of treatment (SVR12), after 12-week treatmentsPopulation: Full Analysis Set (FAS) population includes subjects with genotype 1b HCV infection who were enrolled and received at least one dose of study drugs.
Proportion of subjects with HCV RNA\< LLOQ (lower limit of quantification), TD (target detected) or TND (target not detected) at 12 weeks after the end of treatment (SVR12) in the Full Analysis Set (FAS) population, which include subjects with genotype 1b HCV infection who were enrolled and received at least one dose of study drugs.
Outcome measures
| Measure |
200 mg TG-2349
n=13 Participants
200 mg TG-2349 (2 capsules) + Interferon or Peg-interferon + Ribavirin
|
400 mg TG-2349
n=12 Participants
400 mg TG-2349 (4 capsules) + Interferon or Peg-interferon + Ribavirin
|
|---|---|---|
|
Proportion of Subjects Achieving Sustained Viral Response at 12 Weeks After the End of Treatment.
|
11 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 4, 8, 24 weeks after the end of treatment (SVR4, 8, 24), after 12-week treatmentsPopulation: Full Analysis Set (FAS) population includes subjects with genotype 1b HCV infection who were enrolled and received at least one dose of study drugs.
Outcome measures
| Measure |
200 mg TG-2349
n=13 Participants
200 mg TG-2349 (2 capsules) + Interferon or Peg-interferon + Ribavirin
|
400 mg TG-2349
n=12 Participants
400 mg TG-2349 (4 capsules) + Interferon or Peg-interferon + Ribavirin
|
|---|---|---|
|
Proportion of Subjects Achieving Sustained Viral Response at 4, 8, and 24 Weeks After the End of Treatment (SVR4, SVR8, and SVR24)
SVR4
|
12 Participants
|
10 Participants
|
|
Proportion of Subjects Achieving Sustained Viral Response at 4, 8, and 24 Weeks After the End of Treatment (SVR4, SVR8, and SVR24)
SVR8
|
11 Participants
|
10 Participants
|
|
Proportion of Subjects Achieving Sustained Viral Response at 4, 8, and 24 Weeks After the End of Treatment (SVR4, SVR8, and SVR24)
SVR24
|
11 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: The whole treatment period, 12 weeksPopulation: Full Analysis Set (FAS) population includes subjects with genotype 1b HCV infection who were enrolled and received at least one dose of study drugs. Missing data were excluded in the dominator of on-treatment visits.
Outcome measures
| Measure |
200 mg TG-2349
n=13 Participants
200 mg TG-2349 (2 capsules) + Interferon or Peg-interferon + Ribavirin
|
400 mg TG-2349
n=12 Participants
400 mg TG-2349 (4 capsules) + Interferon or Peg-interferon + Ribavirin
|
|---|---|---|
|
Proportion of Subjects Achieving HCV RNA < Lower Limit of Quantification, Target Detected or Target Not Detected (< LLOQ, TD or TND)
Baseline
|
0 Participants
|
0 Participants
|
|
Proportion of Subjects Achieving HCV RNA < Lower Limit of Quantification, Target Detected or Target Not Detected (< LLOQ, TD or TND)
Day 4
|
1 Participants
|
0 Participants
|
|
Proportion of Subjects Achieving HCV RNA < Lower Limit of Quantification, Target Detected or Target Not Detected (< LLOQ, TD or TND)
Week 1
|
3 Participants
|
4 Participants
|
|
Proportion of Subjects Achieving HCV RNA < Lower Limit of Quantification, Target Detected or Target Not Detected (< LLOQ, TD or TND)
Day 10
|
6 Participants
|
8 Participants
|
|
Proportion of Subjects Achieving HCV RNA < Lower Limit of Quantification, Target Detected or Target Not Detected (< LLOQ, TD or TND)
Week 2
|
9 Participants
|
10 Participants
|
|
Proportion of Subjects Achieving HCV RNA < Lower Limit of Quantification, Target Detected or Target Not Detected (< LLOQ, TD or TND)
Week 3
|
11 Participants
|
10 Participants
|
|
Proportion of Subjects Achieving HCV RNA < Lower Limit of Quantification, Target Detected or Target Not Detected (< LLOQ, TD or TND)
Week 4
|
12 Participants
|
11 Participants
|
|
Proportion of Subjects Achieving HCV RNA < Lower Limit of Quantification, Target Detected or Target Not Detected (< LLOQ, TD or TND)
Week 6
|
11 Participants
|
11 Participants
|
|
Proportion of Subjects Achieving HCV RNA < Lower Limit of Quantification, Target Detected or Target Not Detected (< LLOQ, TD or TND)
Week 8
|
11 Participants
|
11 Participants
|
|
Proportion of Subjects Achieving HCV RNA < Lower Limit of Quantification, Target Detected or Target Not Detected (< LLOQ, TD or TND)
Week 10
|
11 Participants
|
11 Participants
|
|
Proportion of Subjects Achieving HCV RNA < Lower Limit of Quantification, Target Detected or Target Not Detected (< LLOQ, TD or TND)
Week 12
|
11 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Treatment period (12 to 24 weeks) and after the end of treatment (12 to 24 weeks)Population: Full Analysis Set (FAS) population includes subjects with genotype 1b HCV infection who were enrolled and received at least one dose of study drugs. Missing data were excluded in the dominator of on-treatment visits, while imputation was performed at post-treatment visits and the dominator for post-treatment visits was the total population.
Outcome measures
| Measure |
200 mg TG-2349
n=13 Participants
200 mg TG-2349 (2 capsules) + Interferon or Peg-interferon + Ribavirin
|
400 mg TG-2349
n=12 Participants
400 mg TG-2349 (4 capsules) + Interferon or Peg-interferon + Ribavirin
|
|---|---|---|
|
Proportion of Subjects Achieving HCV RNA < LLOQ, TND
Baseline
|
0 Participants
|
0 Participants
|
|
Proportion of Subjects Achieving HCV RNA < LLOQ, TND
Day 4
|
0 Participants
|
0 Participants
|
|
Proportion of Subjects Achieving HCV RNA < LLOQ, TND
Week 1
|
1 Participants
|
1 Participants
|
|
Proportion of Subjects Achieving HCV RNA < LLOQ, TND
Day 10
|
0 Participants
|
3 Participants
|
|
Proportion of Subjects Achieving HCV RNA < LLOQ, TND
Week 2
|
2 Participants
|
4 Participants
|
|
Proportion of Subjects Achieving HCV RNA < LLOQ, TND
Week 3
|
4 Participants
|
9 Participants
|
|
Proportion of Subjects Achieving HCV RNA < LLOQ, TND
Week 4
|
6 Participants
|
9 Participants
|
|
Proportion of Subjects Achieving HCV RNA < LLOQ, TND
Week 6
|
7 Participants
|
10 Participants
|
|
Proportion of Subjects Achieving HCV RNA < LLOQ, TND
Week 8
|
11 Participants
|
10 Participants
|
|
Proportion of Subjects Achieving HCV RNA < LLOQ, TND
Week 10
|
9 Participants
|
11 Participants
|
|
Proportion of Subjects Achieving HCV RNA < LLOQ, TND
Week 12
|
11 Participants
|
10 Participants
|
|
Proportion of Subjects Achieving HCV RNA < LLOQ, TND
Post-Treatment Week 4
|
12 Participants
|
10 Participants
|
|
Proportion of Subjects Achieving HCV RNA < LLOQ, TND
Post-Treatment Week 8
|
11 Participants
|
10 Participants
|
|
Proportion of Subjects Achieving HCV RNA < LLOQ, TND
Post-Treatment Week 12
|
11 Participants
|
9 Participants
|
|
Proportion of Subjects Achieving HCV RNA < LLOQ, TND
Post-Treatment Week 24
|
10 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Treatment period (12 to 24 weeks) and after the end of treatment (12 to 24 weeks)Population: Full Analysis Set (FAS) population includes subjects with genotype 1b HCV infection who were enrolled and received at least one dose of study drugs.
Outcome measures
| Measure |
200 mg TG-2349
n=13 Participants
200 mg TG-2349 (2 capsules) + Interferon or Peg-interferon + Ribavirin
|
400 mg TG-2349
n=12 Participants
400 mg TG-2349 (4 capsules) + Interferon or Peg-interferon + Ribavirin
|
|---|---|---|
|
Mean Absolute Values in HCV RNA (log10 IU/mL)
Baseline
|
5.8 log10 IU/mL
Standard Deviation 0.83
|
5.9 log10 IU/mL
Standard Deviation 0.66
|
|
Mean Absolute Values in HCV RNA (log10 IU/mL)
Day 4
|
1.9 log10 IU/mL
Standard Deviation 0.40
|
2.0 log10 IU/mL
Standard Deviation 0.74
|
|
Mean Absolute Values in HCV RNA (log10 IU/mL)
Week 1
|
1.4 log10 IU/mL
Standard Deviation 0.52
|
1.4 log10 IU/mL
Standard Deviation 0.54
|
|
Mean Absolute Values in HCV RNA (log10 IU/mL)
Day 10
|
1.2 log10 IU/mL
Standard Deviation 0.19
|
1.1 log10 IU/mL
Standard Deviation 0.83
|
|
Mean Absolute Values in HCV RNA (log10 IU/mL)
Week 2
|
1.0 log10 IU/mL
Standard Deviation 0.48
|
1.0 log10 IU/mL
Standard Deviation 0.72
|
|
Mean Absolute Values in HCV RNA (log10 IU/mL)
Week 3
|
0.7 log10 IU/mL
Standard Deviation 0.51
|
0.4 log10 IU/mL
Standard Deviation 0.78
|
|
Mean Absolute Values in HCV RNA (log10 IU/mL)
Week 4
|
0.5 log10 IU/mL
Standard Deviation 0.54
|
0.4 log10 IU/mL
Standard Deviation 0.71
|
|
Mean Absolute Values in HCV RNA (log10 IU/mL)
Week 6
|
0.4 log10 IU/mL
Standard Deviation 0.53
|
0.1 log10 IU/mL
Standard Deviation 0.31
|
|
Mean Absolute Values in HCV RNA (log10 IU/mL)
Week 8
|
0.0 log10 IU/mL
Standard Deviation 0.00
|
0.1 log10 IU/mL
Standard Deviation 0.31
|
|
Mean Absolute Values in HCV RNA (log10 IU/mL)
Week 10
|
0.2 log10 IU/mL
Standard Deviation 0.42
|
0.0 log10 IU/mL
Standard Deviation 0.00
|
|
Mean Absolute Values in HCV RNA (log10 IU/mL)
Week 12
|
0.0 log10 IU/mL
Standard Deviation 0.00
|
0.1 log10 IU/mL
Standard Deviation 0.31
|
|
Mean Absolute Values in HCV RNA (log10 IU/mL)
Post-Treatment Week 4
|
0.0 log10 IU/mL
Standard Deviation 0.00
|
0.8 log10 IU/mL
Standard Deviation 1.79
|
|
Mean Absolute Values in HCV RNA (log10 IU/mL)
Post-Treatment Week 8
|
0.2 log10 IU/mL
Standard Deviation 0.57
|
0.9 log10 IU/mL
Standard Deviation 2.13
|
|
Mean Absolute Values in HCV RNA (log10 IU/mL)
Post-Treatment Week 12
|
0.5 log10 IU/mL
Standard Deviation 1.86
|
1.0 log10 IU/mL
Standard Deviation 2.22
|
|
Mean Absolute Values in HCV RNA (log10 IU/mL)
Post-Treatment Week 24
|
0.1 log10 IU/mL
Standard Deviation 0.31
|
0.0 log10 IU/mL
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: Treatment period (12 to 24 weeks) and after the end of treatment (12 to 24 weeks)Population: Full Analysis Set (FAS) population includes subjects with genotype 1b HCV infection who were enrolled and received at least one dose of study drugs.
Outcome measures
| Measure |
200 mg TG-2349
n=13 Participants
200 mg TG-2349 (2 capsules) + Interferon or Peg-interferon + Ribavirin
|
400 mg TG-2349
n=12 Participants
400 mg TG-2349 (4 capsules) + Interferon or Peg-interferon + Ribavirin
|
|---|---|---|
|
Proportion of Subjects Experiencing Virologic Failure During Treatment and Viral Relapse After the End of Treatment.
Virologic failure
|
1 Participants
|
2 Participants
|
|
Proportion of Subjects Experiencing Virologic Failure During Treatment and Viral Relapse After the End of Treatment.
On-Treatment failure
|
0 Participants
|
1 Participants
|
|
Proportion of Subjects Experiencing Virologic Failure During Treatment and Viral Relapse After the End of Treatment.
Post-Treatment relapse
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From baseline (day 1) to the final treatment visit (week 12 or week 24)Population: Full Analysis Set (FAS) population includes subjects with genotype 1b HCV infection who were enrolled and received at least one dose of study drugs.
Outcome measures
| Measure |
200 mg TG-2349
n=13 Participants
200 mg TG-2349 (2 capsules) + Interferon or Peg-interferon + Ribavirin
|
400 mg TG-2349
n=12 Participants
400 mg TG-2349 (4 capsules) + Interferon or Peg-interferon + Ribavirin
|
|---|---|---|
|
Proportion of Subjects With Abnormal Alanine Aminotransferase (ALT) Levels at Baseline Who Achieved Normal Limit of ALT at Final Treatment Visit.
ALT > ULN at baseline
|
7 Participants
|
7 Participants
|
|
Proportion of Subjects With Abnormal Alanine Aminotransferase (ALT) Levels at Baseline Who Achieved Normal Limit of ALT at Final Treatment Visit.
ALT normalization
|
2 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Treatment period (12 to 24 weeks) and after the end of treatment (12 to 24 weeks)Population: Full Analysis Set (FAS) population includes subjects with genotype 1b HCV infection who were enrolled and received at least one dose of study drugs.
Outcome measures
| Measure |
200 mg TG-2349
n=13 Participants
200 mg TG-2349 (2 capsules) + Interferon or Peg-interferon + Ribavirin
|
400 mg TG-2349
n=12 Participants
400 mg TG-2349 (4 capsules) + Interferon or Peg-interferon + Ribavirin
|
|---|---|---|
|
Change From Baseline in HCV RNA (log10 IU/mL)
Day 4
|
-3.8 log10 IU/mL
Standard Deviation 0.51
|
-3.9 log10 IU/mL
Standard Deviation 0.55
|
|
Change From Baseline in HCV RNA (log10 IU/mL)
Week 1
|
-4.4 log10 IU/mL
Standard Deviation 0.50
|
-4.5 log10 IU/mL
Standard Deviation 0.56
|
|
Change From Baseline in HCV RNA (log10 IU/mL)
Day 10
|
-4.6 log10 IU/mL
Standard Deviation 0.75
|
-4.8 log10 IU/mL
Standard Deviation 0.78
|
|
Change From Baseline in HCV RNA (log10 IU/mL)
Week 2
|
-4.8 log10 IU/mL
Standard Deviation 0.91
|
-4.9 log10 IU/mL
Standard Deviation 1.01
|
|
Change From Baseline in HCV RNA (log10 IU/mL)
Week 3
|
-5.0 log10 IU/mL
Standard Deviation 1.03
|
-5.5 log10 IU/mL
Standard Deviation 0.96
|
|
Change From Baseline in HCV RNA (log10 IU/mL)
Week 4
|
-5.2 log10 IU/mL
Standard Deviation 0.79
|
-5.5 log10 IU/mL
Standard Deviation 0.73
|
|
Change From Baseline in HCV RNA (log10 IU/mL)
Week 6
|
-5.4 log10 IU/mL
Standard Deviation 0.86
|
-5.7 log10 IU/mL
Standard Deviation 0.65
|
|
Change From Baseline in HCV RNA (log10 IU/mL)
Week 8
|
-5.8 log10 IU/mL
Standard Deviation 0.90
|
-5.7 log10 IU/mL
Standard Deviation 0.70
|
|
Change From Baseline in HCV RNA (log10 IU/mL)
Week 10
|
-5.6 log10 IU/mL
Standard Deviation 0.86
|
-5.8 log10 IU/mL
Standard Deviation 0.67
|
|
Change From Baseline in HCV RNA (log10 IU/mL)
Week 12
|
-5.8 log10 IU/mL
Standard Deviation 0.90
|
-5.7 log10 IU/mL
Standard Deviation 0.68
|
|
Change From Baseline in HCV RNA (log10 IU/mL)
Post-Treatment Week 4
|
-5.8 log10 IU/mL
Standard Deviation 0.86
|
-5.1 log10 IU/mL
Standard Deviation 1.72
|
|
Change From Baseline in HCV RNA (log10 IU/mL)
Post-Treatment Week 8
|
-5.6 log10 IU/mL
Standard Deviation 0.88
|
-5.0 log10 IU/mL
Standard Deviation 2.05
|
|
Change From Baseline in HCV RNA (log10 IU/mL)
Post-Treatment Week 12
|
-5.2 log10 IU/mL
Standard Deviation 1.81
|
-4.8 log10 IU/mL
Standard Deviation 2.10
|
|
Change From Baseline in HCV RNA (log10 IU/mL)
Post-Treatment Week 24
|
-5.6 log10 IU/mL
Standard Deviation 0.83
|
-5.8 log10 IU/mL
Standard Deviation 0.70
|
Adverse Events
Group I
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Group II
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group I
n=13 participants at risk
200 mg TG-2349 (2 capsules) + Interferon or Peg-interferon + Ribavirin
|
Group II
n=12 participants at risk
400 mg TG-2349 (4 capsules) + Interferon or Peg-interferon + Ribavirin
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
7.7%
1/13 • Number of events 1 • through study completion, up to 48 weeks
|
0.00%
0/12 • through study completion, up to 48 weeks
|
|
Infections and infestations
Cellulitis
|
7.7%
1/13 • Number of events 1 • through study completion, up to 48 weeks
|
0.00%
0/12 • through study completion, up to 48 weeks
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/13 • through study completion, up to 48 weeks
|
8.3%
1/12 • Number of events 1 • through study completion, up to 48 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/13 • through study completion, up to 48 weeks
|
8.3%
1/12 • Number of events 1 • through study completion, up to 48 weeks
|
Other adverse events
| Measure |
Group I
n=13 participants at risk
200 mg TG-2349 (2 capsules) + Interferon or Peg-interferon + Ribavirin
|
Group II
n=12 participants at risk
400 mg TG-2349 (4 capsules) + Interferon or Peg-interferon + Ribavirin
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
38.5%
5/13 • Number of events 5 • through study completion, up to 48 weeks
|
50.0%
6/12 • Number of events 7 • through study completion, up to 48 weeks
|
|
Blood and lymphatic system disorders
Neutropenia
|
46.2%
6/13 • Number of events 7 • through study completion, up to 48 weeks
|
25.0%
3/12 • Number of events 3 • through study completion, up to 48 weeks
|
|
Blood and lymphatic system disorders
Leukopenia
|
30.8%
4/13 • Number of events 6 • through study completion, up to 48 weeks
|
16.7%
2/12 • Number of events 3 • through study completion, up to 48 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
30.8%
4/13 • Number of events 4 • through study completion, up to 48 weeks
|
41.7%
5/12 • Number of events 6 • through study completion, up to 48 weeks
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
23.1%
3/13 • Number of events 3 • through study completion, up to 48 weeks
|
16.7%
2/12 • Number of events 2 • through study completion, up to 48 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.7%
1/13 • Number of events 1 • through study completion, up to 48 weeks
|
16.7%
2/12 • Number of events 2 • through study completion, up to 48 weeks
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.7%
1/13 • Number of events 1 • through study completion, up to 48 weeks
|
8.3%
1/12 • Number of events 1 • through study completion, up to 48 weeks
|
|
Skin and subcutaneous tissue disorders
Eczema
|
7.7%
1/13 • Number of events 1 • through study completion, up to 48 weeks
|
0.00%
0/12 • through study completion, up to 48 weeks
|
|
Skin and subcutaneous tissue disorders
Papule
|
7.7%
1/13 • Number of events 1 • through study completion, up to 48 weeks
|
0.00%
0/12 • through study completion, up to 48 weeks
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
7.7%
1/13 • Number of events 1 • through study completion, up to 48 weeks
|
0.00%
0/12 • through study completion, up to 48 weeks
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/13 • through study completion, up to 48 weeks
|
8.3%
1/12 • Number of events 1 • through study completion, up to 48 weeks
|
|
Skin and subcutaneous tissue disorders
Vesicle
|
0.00%
0/13 • through study completion, up to 48 weeks
|
8.3%
1/12 • Number of events 1 • through study completion, up to 48 weeks
|
|
General disorders
Pain
|
38.5%
5/13 • Number of events 5 • through study completion, up to 48 weeks
|
41.7%
5/12 • Number of events 6 • through study completion, up to 48 weeks
|
|
General disorders
Pyrexia
|
15.4%
2/13 • Number of events 2 • through study completion, up to 48 weeks
|
33.3%
4/12 • Number of events 5 • through study completion, up to 48 weeks
|
|
General disorders
Chest discomfort
|
15.4%
2/13 • Number of events 2 • through study completion, up to 48 weeks
|
8.3%
1/12 • Number of events 1 • through study completion, up to 48 weeks
|
|
General disorders
Fatigue
|
7.7%
1/13 • Number of events 1 • through study completion, up to 48 weeks
|
16.7%
2/12 • Number of events 2 • through study completion, up to 48 weeks
|
|
General disorders
Chest pain
|
7.7%
1/13 • Number of events 1 • through study completion, up to 48 weeks
|
8.3%
1/12 • Number of events 1 • through study completion, up to 48 weeks
|
|
General disorders
Feeling cold
|
7.7%
1/13 • Number of events 2 • through study completion, up to 48 weeks
|
8.3%
1/12 • Number of events 1 • through study completion, up to 48 weeks
|
|
General disorders
Asthenia
|
7.7%
1/13 • Number of events 1 • through study completion, up to 48 weeks
|
0.00%
0/12 • through study completion, up to 48 weeks
|
|
General disorders
Injection site erythema
|
0.00%
0/13 • through study completion, up to 48 weeks
|
8.3%
1/12 • Number of events 1 • through study completion, up to 48 weeks
|
|
General disorders
Injection site rash
|
7.7%
1/13 • Number of events 1 • through study completion, up to 48 weeks
|
0.00%
0/12 • through study completion, up to 48 weeks
|
|
General disorders
Local swelling
|
7.7%
1/13 • Number of events 2 • through study completion, up to 48 weeks
|
0.00%
0/12 • through study completion, up to 48 weeks
|
|
General disorders
Malaise
|
0.00%
0/13 • through study completion, up to 48 weeks
|
8.3%
1/12 • Number of events 1 • through study completion, up to 48 weeks
|
|
General disorders
Thirst
|
7.7%
1/13 • Number of events 1 • through study completion, up to 48 weeks
|
0.00%
0/12 • through study completion, up to 48 weeks
|
|
Nervous system disorders
Dizziness
|
30.8%
4/13 • Number of events 6 • through study completion, up to 48 weeks
|
33.3%
4/12 • Number of events 4 • through study completion, up to 48 weeks
|
|
Nervous system disorders
Headache
|
30.8%
4/13 • Number of events 7 • through study completion, up to 48 weeks
|
25.0%
3/12 • Number of events 3 • through study completion, up to 48 weeks
|
|
Nervous system disorders
Memory impairment
|
15.4%
2/13 • Number of events 2 • through study completion, up to 48 weeks
|
8.3%
1/12 • Number of events 1 • through study completion, up to 48 weeks
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/13 • through study completion, up to 48 weeks
|
8.3%
1/12 • Number of events 1 • through study completion, up to 48 weeks
|
|
Gastrointestinal disorders
Mouth ulceration
|
23.1%
3/13 • Number of events 3 • through study completion, up to 48 weeks
|
25.0%
3/12 • Number of events 4 • through study completion, up to 48 weeks
|
|
Gastrointestinal disorders
Nausea
|
23.1%
3/13 • Number of events 4 • through study completion, up to 48 weeks
|
8.3%
1/12 • Number of events 1 • through study completion, up to 48 weeks
|
|
Gastrointestinal disorders
Abdominal distension
|
7.7%
1/13 • Number of events 1 • through study completion, up to 48 weeks
|
8.3%
1/12 • Number of events 1 • through study completion, up to 48 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
7.7%
1/13 • Number of events 1 • through study completion, up to 48 weeks
|
8.3%
1/12 • Number of events 1 • through study completion, up to 48 weeks
|
|
Gastrointestinal disorders
Dry mouth
|
7.7%
1/13 • Number of events 1 • through study completion, up to 48 weeks
|
8.3%
1/12 • Number of events 1 • through study completion, up to 48 weeks
|
|
Gastrointestinal disorders
Faeces soft
|
7.7%
1/13 • Number of events 1 • through study completion, up to 48 weeks
|
0.00%
0/12 • through study completion, up to 48 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
7.7%
1/13 • Number of events 1 • through study completion, up to 48 weeks
|
0.00%
0/12 • through study completion, up to 48 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.7%
1/13 • Number of events 1 • through study completion, up to 48 weeks
|
0.00%
0/12 • through study completion, up to 48 weeks
|
|
Gastrointestinal disorders
Toothache
|
7.7%
1/13 • Number of events 1 • through study completion, up to 48 weeks
|
0.00%
0/12 • through study completion, up to 48 weeks
|
|
Gastrointestinal disorders
Vomiting
|
7.7%
1/13 • Number of events 1 • through study completion, up to 48 weeks
|
0.00%
0/12 • through study completion, up to 48 weeks
|
|
Infections and infestations
Cellulitis
|
0.00%
0/13 • through study completion, up to 48 weeks
|
8.3%
1/12 • Number of events 1 • through study completion, up to 48 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
7.7%
1/13 • Number of events 1 • through study completion, up to 48 weeks
|
8.3%
1/12 • Number of events 1 • through study completion, up to 48 weeks
|
|
Infections and infestations
Folliculitis
|
7.7%
1/13 • Number of events 1 • through study completion, up to 48 weeks
|
0.00%
0/12 • through study completion, up to 48 weeks
|
|
Infections and infestations
Gingivitis
|
0.00%
0/13 • through study completion, up to 48 weeks
|
8.3%
1/12 • Number of events 1 • through study completion, up to 48 weeks
|
|
Infections and infestations
Infected dermal cyst
|
0.00%
0/13 • through study completion, up to 48 weeks
|
8.3%
1/12 • Number of events 1 • through study completion, up to 48 weeks
|
|
Infections and infestations
Nasopharyngitis
|
7.7%
1/13 • Number of events 1 • through study completion, up to 48 weeks
|
0.00%
0/12 • through study completion, up to 48 weeks
|
|
Infections and infestations
Otitis media
|
0.00%
0/13 • through study completion, up to 48 weeks
|
8.3%
1/12 • Number of events 1 • through study completion, up to 48 weeks
|
|
Infections and infestations
Pyuria
|
7.7%
1/13 • Number of events 1 • through study completion, up to 48 weeks
|
0.00%
0/12 • through study completion, up to 48 weeks
|
|
Infections and infestations
Tonsillitis
|
7.7%
1/13 • Number of events 1 • through study completion, up to 48 weeks
|
0.00%
0/12 • through study completion, up to 48 weeks
|
|
Psychiatric disorders
Insomnia
|
30.8%
4/13 • Number of events 4 • through study completion, up to 48 weeks
|
8.3%
1/12 • Number of events 1 • through study completion, up to 48 weeks
|
|
Psychiatric disorders
Anxiety
|
7.7%
1/13 • Number of events 1 • through study completion, up to 48 weeks
|
8.3%
1/12 • Number of events 2 • through study completion, up to 48 weeks
|
|
Psychiatric disorders
Attention deficit/hyperactivity disorder
|
7.7%
1/13 • Number of events 1 • through study completion, up to 48 weeks
|
8.3%
1/12 • Number of events 2 • through study completion, up to 48 weeks
|
|
Psychiatric disorders
Depression
|
0.00%
0/13 • through study completion, up to 48 weeks
|
8.3%
1/12 • Number of events 1 • through study completion, up to 48 weeks
|
|
Psychiatric disorders
Irritability
|
7.7%
1/13 • Number of events 1 • through study completion, up to 48 weeks
|
0.00%
0/12 • through study completion, up to 48 weeks
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/13 • through study completion, up to 48 weeks
|
8.3%
1/12 • Number of events 1 • through study completion, up to 48 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.4%
2/13 • Number of events 2 • through study completion, up to 48 weeks
|
25.0%
3/12 • Number of events 3 • through study completion, up to 48 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.7%
1/13 • Number of events 1 • through study completion, up to 48 weeks
|
0.00%
0/12 • through study completion, up to 48 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/13 • through study completion, up to 48 weeks
|
8.3%
1/12 • Number of events 1 • through study completion, up to 48 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/13 • through study completion, up to 48 weeks
|
8.3%
1/12 • Number of events 1 • through study completion, up to 48 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
7.7%
1/13 • Number of events 1 • through study completion, up to 48 weeks
|
0.00%
0/12 • through study completion, up to 48 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
23.1%
3/13 • Number of events 3 • through study completion, up to 48 weeks
|
25.0%
3/12 • Number of events 3 • through study completion, up to 48 weeks
|
|
Metabolism and nutrition disorders
Musculoskeletal and connective tissue disorders
|
15.4%
2/13 • Number of events 2 • through study completion, up to 48 weeks
|
8.3%
1/12 • Number of events 1 • through study completion, up to 48 weeks
|
|
Metabolism and nutrition disorders
Back pain
|
15.4%
2/13 • Number of events 2 • through study completion, up to 48 weeks
|
0.00%
0/12 • through study completion, up to 48 weeks
|
|
Metabolism and nutrition disorders
Plantar fasciitis
|
0.00%
0/13 • through study completion, up to 48 weeks
|
8.3%
1/12 • Number of events 1 • through study completion, up to 48 weeks
|
|
Investigations
Blood bilirubin increased
|
7.7%
1/13 • Number of events 1 • through study completion, up to 48 weeks
|
8.3%
1/12 • Number of events 1 • through study completion, up to 48 weeks
|
|
Investigations
Alanine aminotransferase increased
|
7.7%
1/13 • Number of events 1 • through study completion, up to 48 weeks
|
0.00%
0/12 • through study completion, up to 48 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
7.7%
1/13 • Number of events 1 • through study completion, up to 48 weeks
|
0.00%
0/12 • through study completion, up to 48 weeks
|
|
Investigations
Blood creatine phosphokinase increased
|
7.7%
1/13 • Number of events 1 • through study completion, up to 48 weeks
|
0.00%
0/12 • through study completion, up to 48 weeks
|
|
Investigations
Gamma-glutamyltransferase increased
|
7.7%
1/13 • Number of events 1 • through study completion, up to 48 weeks
|
0.00%
0/12 • through study completion, up to 48 weeks
|
|
Investigations
Platelet count decreased
|
0.00%
0/13 • through study completion, up to 48 weeks
|
8.3%
1/12 • Number of events 1 • through study completion, up to 48 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
7.7%
1/13 • Number of events 1 • through study completion, up to 48 weeks
|
0.00%
0/12 • through study completion, up to 48 weeks
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/13 • through study completion, up to 48 weeks
|
8.3%
1/12 • Number of events 1 • through study completion, up to 48 weeks
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
7.7%
1/13 • Number of events 1 • through study completion, up to 48 weeks
|
0.00%
0/12 • through study completion, up to 48 weeks
|
|
Injury, poisoning and procedural complications
Wound
|
7.7%
1/13 • Number of events 1 • through study completion, up to 48 weeks
|
0.00%
0/12 • through study completion, up to 48 weeks
|
|
Eye disorders
Dry eye
|
7.7%
1/13 • Number of events 1 • through study completion, up to 48 weeks
|
8.3%
1/12 • Number of events 1 • through study completion, up to 48 weeks
|
|
Ear and labyrinth disorders
Vertigo
|
7.7%
1/13 • Number of events 1 • through study completion, up to 48 weeks
|
0.00%
0/12 • through study completion, up to 48 weeks
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/13 • through study completion, up to 48 weeks
|
8.3%
1/12 • Number of events 1 • through study completion, up to 48 weeks
|
|
Vascular disorders
Hypertension
|
7.7%
1/13 • Number of events 1 • through study completion, up to 48 weeks
|
0.00%
0/12 • through study completion, up to 48 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60