Trial Outcomes & Findings for Study of Combination Treatment With IMO-2125 and Ribavirin in Naïve Hepatitis C-infected, Genotype 1 Patients (NCT NCT00990938)
NCT ID: NCT00990938
Last Updated: 2019-02-15
Results Overview
The number and percentage of subjects who experienced at least one treatment-emergent adverse event by category.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
63 participants
Primary outcome timeframe
From first dose of study treatment to day 59 (end of study)
Results posted on
2019-02-15
Participant Flow
Participant milestones
| Measure |
Placebo + Ribavirin
Placebo cohort: Saline (placebo) sc once weekly + Ribavirin (1000 mg dose for patients \<75 kg; 1200 mg dose for patients ≥75 kg) administered orally in 2 divided oral doses.
|
IMO-2125 0.08 mg/kg Weekly + Ribavirin
First experimental cohort: IMO-2125 0.08 mg/kg weekly + Ribavirin (1000 mg dose for patients \<75 kg; 1200 mg dose for patients ≥75 kg), administered orally in 2 divided oral doses.
|
IMO-2125 0.16 mg/kg Weekly + Ribavirin
Second experimental cohort: IMO-2125 0.16 mg/kg weekly + Ribavirin (1000 mg dose for patients \<75 kg; 1200 mg dose for patients ≥75 kg), administered orally in 2 divided oral doses.
|
IMO-2125 0.32 mg/kg Weekly + Ribavirin
Third experimental cohort: IMO-2125 0.32 mg/kg weekly + Ribavirin (1000 mg dose for patients \<75 kg; 1200 mg dose for patients ≥75 kg), administered orally in 2 divided oral doses.
|
IMO-2125 0.16 mg/kg Twice Weekly + Ribavirin
Fourth experimental cohort: IMO-2125 0.16 mg/kg twice weekly + Ribavirin (1000 mg dose for patients \<75 kg; 1200 mg dose for patients ≥75 kg), administered orally in 2 divided oral doses.
|
Peg-rIFN + Ribavirin
Active comparator cohort: Peg-rIFN 180 µg sc once weekly + Ribavirin (1000 mg dose for patients \<75 kg; 1200 mg dose for patients ≥75 kg) administered orally in 2 divided oral doses.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
12
|
12
|
12
|
12
|
12
|
|
Overall Study
COMPLETED
|
3
|
12
|
12
|
12
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Combination Treatment With IMO-2125 and Ribavirin in Naïve Hepatitis C-infected, Genotype 1 Patients
Baseline characteristics by cohort
| Measure |
Placebo + Ribavirin
n=3 Participants
Placebo cohort: Saline (placebo) sc once weekly + Ribavirin (1000 mg dose for patients \<75 kg; 1200 mg dose for patients ≥75 kg) administered orally in 2 divided oral doses.
|
IMO-2125 0.08 mg/kg Weekly + Ribavirin
n=12 Participants
First experimental cohort: IMO-2125 0.08 mg/kg weekly + Ribavirin (1000 mg dose for patients \<75 kg; 1200 mg dose for patients ≥75 kg), administered orally in 2 divided oral doses.
|
IMO-2125 0.16 mg/kg Weekly + Ribavirin
n=12 Participants
Second experimental cohort: IMO-2125 0.16 mg/kg weekly + Ribavirin (1000 mg dose for patients \<75 kg; 1200 mg dose for patients ≥75 kg), administered orally in 2 divided oral doses.
|
IMO-2125 0.32 mg/kg Weekly + Ribavirin
n=12 Participants
Third experimental cohort: IMO-2125 0.32 mg/kg weekly + Ribavirin (1000 mg dose for patients \<75 kg; 1200 mg dose for patients ≥75 kg), administered orally in 2 divided oral doses.
|
IMO-2125 0.16 mg/kg Twice Weekly + Ribavirin
n=12 Participants
Fourth experimental cohort: IMO-2125 0.16 mg/kg twice weekly + Ribavirin (1000 mg dose for patients \<75 kg; 1200 mg dose for patients ≥75 kg), administered orally in 2 divided oral doses.
|
Peg-rIFN + Ribavirin
n=12 Participants
Active comparator cohort: Peg-rIFN 180 µg sc once weekly + Ribavirin (1000 mg dose for patients \<75 kg; 1200 mg dose for patients ≥75 kg) administered orally in 2 divided oral doses.
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
30.0 years
n=99 Participants
|
40.5 years
n=107 Participants
|
38.0 years
n=206 Participants
|
48.5 years
n=7 Participants
|
42.5 years
n=31 Participants
|
32.0 years
n=30 Participants
|
39.0 years
n=3 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
24 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
9 Participants
n=30 Participants
|
39 Participants
n=3 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=31 Participants
|
12 Participants
n=30 Participants
|
62 Participants
n=3 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Body Mass Index (BMI)
|
22.4 kg/m^2
n=99 Participants
|
24.3 kg/m^2
n=107 Participants
|
22.7 kg/m^2
n=206 Participants
|
27.3 kg/m^2
n=7 Participants
|
24.1 kg/m^2
n=31 Participants
|
24.9 kg/m^2
n=30 Participants
|
24.8 kg/m^2
n=3 Participants
|
PRIMARY outcome
Timeframe: From first dose of study treatment to day 59 (end of study)Population: Safety population
The number and percentage of subjects who experienced at least one treatment-emergent adverse event by category.
Outcome measures
| Measure |
Placebo + Ribavirin
n=3 Participants
Placebo cohort: Saline (placebo) sc once weekly + Ribavirin (1000 mg dose for patients \<75 kg; 1200 mg dose for patients ≥75 kg) administered orally in 2 divided oral doses.
|
IMO-2125 0.08 mg/kg Weekly + Ribavirin
n=12 Participants
First experimental cohort: IMO-2125 0.08 mg/kg weekly + Ribavirin (1000 mg dose for patients \<75 kg; 1200 mg dose for patients ≥75 kg), administered orally in 2 divided oral doses.
|
IMO-2125 0.16 mg/kg Weekly + Ribavirin
n=12 Participants
Second experimental cohort: IMO-2125 0.16 mg/kg weekly + Ribavirin (1000 mg dose for patients \<75 kg; 1200 mg dose for patients ≥75 kg), administered orally in 2 divided oral doses.
|
IMO-2125 0.32 mg/kg Weekly + Ribavirin
n=12 Participants
Third experimental cohort: IMO-2125 0.32 mg/kg weekly + Ribavirin (1000 mg dose for patients \<75 kg; 1200 mg dose for patients ≥75 kg), administered orally in 2 divided oral doses.
|
IMO-2125 0.16 mg/kg Twice Weekly + Ribavirin
n=12 Participants
Fourth experimental cohort: IMO-2125 0.16 mg/kg twice weekly + Ribavirin (1000 mg dose for patients \<75 kg; 1200 mg dose for patients ≥75 kg), administered orally in 2 divided oral doses.
|
Peg-rIFN + Ribavirin
n=12 Participants
Active comparator cohort: Peg-rIFN 180 µg sc once weekly + Ribavirin (1000 mg dose for patients \<75 kg; 1200 mg dose for patients ≥75 kg) administered orally in 2 divided oral doses.
|
|---|---|---|---|---|---|---|
|
At Least 1 TEAE
At least 1 severe/life threatening TEAE
|
0 Participants
|
2 Participants
|
7 Participants
|
2 Participants
|
3 Participants
|
7 Participants
|
|
At Least 1 TEAE
At least 1 injection site reaction
|
0 Participants
|
12 Participants
|
12 Participants
|
11 Participants
|
12 Participants
|
9 Participants
|
|
At Least 1 TEAE
At least 1 TEAE
|
2 Participants
|
12 Participants
|
12 Participants
|
12 Participants
|
12 Participants
|
12 Participants
|
|
At Least 1 TEAE
At least 2 TEAE related to study drug
|
2 Participants
|
12 Participants
|
12 Participants
|
12 Participants
|
12 Participants
|
12 Participants
|
|
At Least 1 TEAE
At least 1 TEAE that led to discontinuation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Placebo + Ribavirin
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
IMO-2125 0.08 mg/kg Weekly + Ribavirin
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
IMO-2125 0.16 mg/kg Weekly + Ribavirin
Serious events: 7 serious events
Other events: 12 other events
Deaths: 0 deaths
IMO-2125 0.32 mg/kg Weekly + Ribavirin
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
IMO-2125 0.16 mg/kg Twice Weekly + Ribavirin
Serious events: 3 serious events
Other events: 12 other events
Deaths: 0 deaths
Peg-rIFN + Ribavirin
Serious events: 11 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo + Ribavirin
n=3 participants at risk
Placebo cohort: Saline (placebo) sc once weekly + Ribavirin (1000 mg dose for patients \<75 kg; 1200 mg dose for patients ≥75 kg) administered orally in 2 divided oral doses.
|
IMO-2125 0.08 mg/kg Weekly + Ribavirin
n=12 participants at risk
First experimental cohort: IMO-2125 0.08 mg/kg weekly + Ribavirin (1000 mg dose for patients \<75 kg; 1200 mg dose for patients ≥75 kg), administered orally in 2 divided oral doses.
|
IMO-2125 0.16 mg/kg Weekly + Ribavirin
n=12 participants at risk
Second experimental cohort: IMO-2125 0.16 mg/kg weekly + Ribavirin (1000 mg dose for patients \<75 kg; 1200 mg dose for patients ≥75 kg), administered orally in 2 divided oral doses.
|
IMO-2125 0.32 mg/kg Weekly + Ribavirin
n=12 participants at risk
Third experimental cohort: IMO-2125 0.32 mg/kg weekly + Ribavirin (1000 mg dose for patients \<75 kg; 1200 mg dose for patients ≥75 kg), administered orally in 2 divided oral doses.
|
IMO-2125 0.16 mg/kg Twice Weekly + Ribavirin
n=12 participants at risk
Fourth experimental cohort: IMO-2125 0.16 mg/kg twice weekly + Ribavirin (1000 mg dose for patients \<75 kg; 1200 mg dose for patients ≥75 kg), administered orally in 2 divided oral doses.
|
Peg-rIFN + Ribavirin
n=12 participants at risk
Active comparator cohort: Peg-rIFN 180 µg sc once weekly + Ribavirin (1000 mg dose for patients \<75 kg; 1200 mg dose for patients ≥75 kg) administered orally in 2 divided oral doses.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3 • From start of study treatment to day 59 (end of study)
|
8.3%
1/12 • From start of study treatment to day 59 (end of study)
|
8.3%
1/12 • From start of study treatment to day 59 (end of study)
|
0.00%
0/12 • From start of study treatment to day 59 (end of study)
|
0.00%
0/12 • From start of study treatment to day 59 (end of study)
|
25.0%
3/12 • From start of study treatment to day 59 (end of study)
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • From start of study treatment to day 59 (end of study)
|
0.00%
0/12 • From start of study treatment to day 59 (end of study)
|
8.3%
1/12 • From start of study treatment to day 59 (end of study)
|
8.3%
1/12 • From start of study treatment to day 59 (end of study)
|
8.3%
1/12 • From start of study treatment to day 59 (end of study)
|
50.0%
6/12 • From start of study treatment to day 59 (end of study)
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/3 • From start of study treatment to day 59 (end of study)
|
0.00%
0/12 • From start of study treatment to day 59 (end of study)
|
0.00%
0/12 • From start of study treatment to day 59 (end of study)
|
0.00%
0/12 • From start of study treatment to day 59 (end of study)
|
0.00%
0/12 • From start of study treatment to day 59 (end of study)
|
8.3%
1/12 • From start of study treatment to day 59 (end of study)
|
|
General disorders
Flu like symptoms
|
0.00%
0/3 • From start of study treatment to day 59 (end of study)
|
0.00%
0/12 • From start of study treatment to day 59 (end of study)
|
16.7%
2/12 • From start of study treatment to day 59 (end of study)
|
0.00%
0/12 • From start of study treatment to day 59 (end of study)
|
16.7%
2/12 • From start of study treatment to day 59 (end of study)
|
0.00%
0/12 • From start of study treatment to day 59 (end of study)
|
|
General disorders
Pyrexia
|
0.00%
0/3 • From start of study treatment to day 59 (end of study)
|
0.00%
0/12 • From start of study treatment to day 59 (end of study)
|
16.7%
2/12 • From start of study treatment to day 59 (end of study)
|
8.3%
1/12 • From start of study treatment to day 59 (end of study)
|
0.00%
0/12 • From start of study treatment to day 59 (end of study)
|
0.00%
0/12 • From start of study treatment to day 59 (end of study)
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/3 • From start of study treatment to day 59 (end of study)
|
8.3%
1/12 • From start of study treatment to day 59 (end of study)
|
8.3%
1/12 • From start of study treatment to day 59 (end of study)
|
0.00%
0/12 • From start of study treatment to day 59 (end of study)
|
0.00%
0/12 • From start of study treatment to day 59 (end of study)
|
8.3%
1/12 • From start of study treatment to day 59 (end of study)
|
Other adverse events
| Measure |
Placebo + Ribavirin
n=3 participants at risk
Placebo cohort: Saline (placebo) sc once weekly + Ribavirin (1000 mg dose for patients \<75 kg; 1200 mg dose for patients ≥75 kg) administered orally in 2 divided oral doses.
|
IMO-2125 0.08 mg/kg Weekly + Ribavirin
n=12 participants at risk
First experimental cohort: IMO-2125 0.08 mg/kg weekly + Ribavirin (1000 mg dose for patients \<75 kg; 1200 mg dose for patients ≥75 kg), administered orally in 2 divided oral doses.
|
IMO-2125 0.16 mg/kg Weekly + Ribavirin
n=12 participants at risk
Second experimental cohort: IMO-2125 0.16 mg/kg weekly + Ribavirin (1000 mg dose for patients \<75 kg; 1200 mg dose for patients ≥75 kg), administered orally in 2 divided oral doses.
|
IMO-2125 0.32 mg/kg Weekly + Ribavirin
n=12 participants at risk
Third experimental cohort: IMO-2125 0.32 mg/kg weekly + Ribavirin (1000 mg dose for patients \<75 kg; 1200 mg dose for patients ≥75 kg), administered orally in 2 divided oral doses.
|
IMO-2125 0.16 mg/kg Twice Weekly + Ribavirin
n=12 participants at risk
Fourth experimental cohort: IMO-2125 0.16 mg/kg twice weekly + Ribavirin (1000 mg dose for patients \<75 kg; 1200 mg dose for patients ≥75 kg), administered orally in 2 divided oral doses.
|
Peg-rIFN + Ribavirin
n=12 participants at risk
Active comparator cohort: Peg-rIFN 180 µg sc once weekly + Ribavirin (1000 mg dose for patients \<75 kg; 1200 mg dose for patients ≥75 kg) administered orally in 2 divided oral doses.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/3 • From start of study treatment to day 59 (end of study)
|
16.7%
2/12 • From start of study treatment to day 59 (end of study)
|
25.0%
3/12 • From start of study treatment to day 59 (end of study)
|
8.3%
1/12 • From start of study treatment to day 59 (end of study)
|
16.7%
2/12 • From start of study treatment to day 59 (end of study)
|
8.3%
1/12 • From start of study treatment to day 59 (end of study)
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3 • From start of study treatment to day 59 (end of study)
|
0.00%
0/12 • From start of study treatment to day 59 (end of study)
|
58.3%
7/12 • From start of study treatment to day 59 (end of study)
|
16.7%
2/12 • From start of study treatment to day 59 (end of study)
|
58.3%
7/12 • From start of study treatment to day 59 (end of study)
|
83.3%
10/12 • From start of study treatment to day 59 (end of study)
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • From start of study treatment to day 59 (end of study)
|
0.00%
0/12 • From start of study treatment to day 59 (end of study)
|
41.7%
5/12 • From start of study treatment to day 59 (end of study)
|
0.00%
0/12 • From start of study treatment to day 59 (end of study)
|
66.7%
8/12 • From start of study treatment to day 59 (end of study)
|
83.3%
10/12 • From start of study treatment to day 59 (end of study)
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • From start of study treatment to day 59 (end of study)
|
16.7%
2/12 • From start of study treatment to day 59 (end of study)
|
16.7%
2/12 • From start of study treatment to day 59 (end of study)
|
16.7%
2/12 • From start of study treatment to day 59 (end of study)
|
25.0%
3/12 • From start of study treatment to day 59 (end of study)
|
8.3%
1/12 • From start of study treatment to day 59 (end of study)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • From start of study treatment to day 59 (end of study)
|
0.00%
0/12 • From start of study treatment to day 59 (end of study)
|
8.3%
1/12 • From start of study treatment to day 59 (end of study)
|
8.3%
1/12 • From start of study treatment to day 59 (end of study)
|
16.7%
2/12 • From start of study treatment to day 59 (end of study)
|
0.00%
0/12 • From start of study treatment to day 59 (end of study)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • From start of study treatment to day 59 (end of study)
|
0.00%
0/12 • From start of study treatment to day 59 (end of study)
|
16.7%
2/12 • From start of study treatment to day 59 (end of study)
|
0.00%
0/12 • From start of study treatment to day 59 (end of study)
|
0.00%
0/12 • From start of study treatment to day 59 (end of study)
|
0.00%
0/12 • From start of study treatment to day 59 (end of study)
|
|
General disorders
Asthenia
|
0.00%
0/3 • From start of study treatment to day 59 (end of study)
|
16.7%
2/12 • From start of study treatment to day 59 (end of study)
|
33.3%
4/12 • From start of study treatment to day 59 (end of study)
|
33.3%
4/12 • From start of study treatment to day 59 (end of study)
|
41.7%
5/12 • From start of study treatment to day 59 (end of study)
|
25.0%
3/12 • From start of study treatment to day 59 (end of study)
|
|
General disorders
Chills
|
33.3%
1/3 • From start of study treatment to day 59 (end of study)
|
41.7%
5/12 • From start of study treatment to day 59 (end of study)
|
0.00%
0/12 • From start of study treatment to day 59 (end of study)
|
25.0%
3/12 • From start of study treatment to day 59 (end of study)
|
33.3%
4/12 • From start of study treatment to day 59 (end of study)
|
8.3%
1/12 • From start of study treatment to day 59 (end of study)
|
|
General disorders
Fatigue
|
33.3%
1/3 • From start of study treatment to day 59 (end of study)
|
25.0%
3/12 • From start of study treatment to day 59 (end of study)
|
8.3%
1/12 • From start of study treatment to day 59 (end of study)
|
8.3%
1/12 • From start of study treatment to day 59 (end of study)
|
8.3%
1/12 • From start of study treatment to day 59 (end of study)
|
0.00%
0/12 • From start of study treatment to day 59 (end of study)
|
|
General disorders
Influenza-like illness
|
33.3%
1/3 • From start of study treatment to day 59 (end of study)
|
41.7%
5/12 • From start of study treatment to day 59 (end of study)
|
66.7%
8/12 • From start of study treatment to day 59 (end of study)
|
25.0%
3/12 • From start of study treatment to day 59 (end of study)
|
41.7%
5/12 • From start of study treatment to day 59 (end of study)
|
66.7%
8/12 • From start of study treatment to day 59 (end of study)
|
|
General disorders
Injection site discoloration
|
0.00%
0/3 • From start of study treatment to day 59 (end of study)
|
16.7%
2/12 • From start of study treatment to day 59 (end of study)
|
0.00%
0/12 • From start of study treatment to day 59 (end of study)
|
0.00%
0/12 • From start of study treatment to day 59 (end of study)
|
0.00%
0/12 • From start of study treatment to day 59 (end of study)
|
0.00%
0/12 • From start of study treatment to day 59 (end of study)
|
|
General disorders
Injection site erythema
|
0.00%
0/3 • From start of study treatment to day 59 (end of study)
|
0.00%
0/12 • From start of study treatment to day 59 (end of study)
|
100.0%
12/12 • From start of study treatment to day 59 (end of study)
|
91.7%
11/12 • From start of study treatment to day 59 (end of study)
|
100.0%
12/12 • From start of study treatment to day 59 (end of study)
|
75.0%
9/12 • From start of study treatment to day 59 (end of study)
|
|
General disorders
Injection site hematoma
|
0.00%
0/3 • From start of study treatment to day 59 (end of study)
|
0.00%
0/12 • From start of study treatment to day 59 (end of study)
|
8.3%
1/12 • From start of study treatment to day 59 (end of study)
|
0.00%
0/12 • From start of study treatment to day 59 (end of study)
|
0.00%
0/12 • From start of study treatment to day 59 (end of study)
|
8.3%
1/12 • From start of study treatment to day 59 (end of study)
|
|
General disorders
Injection site induration
|
0.00%
0/3 • From start of study treatment to day 59 (end of study)
|
0.00%
0/12 • From start of study treatment to day 59 (end of study)
|
58.3%
7/12 • From start of study treatment to day 59 (end of study)
|
66.7%
8/12 • From start of study treatment to day 59 (end of study)
|
75.0%
9/12 • From start of study treatment to day 59 (end of study)
|
25.0%
3/12 • From start of study treatment to day 59 (end of study)
|
|
General disorders
Injection site pain
|
0.00%
0/3 • From start of study treatment to day 59 (end of study)
|
0.00%
0/12 • From start of study treatment to day 59 (end of study)
|
91.7%
11/12 • From start of study treatment to day 59 (end of study)
|
75.0%
9/12 • From start of study treatment to day 59 (end of study)
|
83.3%
10/12 • From start of study treatment to day 59 (end of study)
|
25.0%
3/12 • From start of study treatment to day 59 (end of study)
|
|
General disorders
Injection site pruritus
|
0.00%
0/3 • From start of study treatment to day 59 (end of study)
|
8.3%
1/12 • From start of study treatment to day 59 (end of study)
|
25.0%
3/12 • From start of study treatment to day 59 (end of study)
|
25.0%
3/12 • From start of study treatment to day 59 (end of study)
|
0.00%
0/12 • From start of study treatment to day 59 (end of study)
|
0.00%
0/12 • From start of study treatment to day 59 (end of study)
|
|
General disorders
Irritability
|
0.00%
0/3 • From start of study treatment to day 59 (end of study)
|
0.00%
0/12 • From start of study treatment to day 59 (end of study)
|
0.00%
0/12 • From start of study treatment to day 59 (end of study)
|
0.00%
0/12 • From start of study treatment to day 59 (end of study)
|
8.3%
1/12 • From start of study treatment to day 59 (end of study)
|
8.3%
1/12 • From start of study treatment to day 59 (end of study)
|
|
General disorders
Pyrexia
|
33.3%
1/3 • From start of study treatment to day 59 (end of study)
|
66.7%
8/12 • From start of study treatment to day 59 (end of study)
|
33.3%
4/12 • From start of study treatment to day 59 (end of study)
|
91.7%
11/12 • From start of study treatment to day 59 (end of study)
|
75.0%
9/12 • From start of study treatment to day 59 (end of study)
|
41.7%
5/12 • From start of study treatment to day 59 (end of study)
|
|
Hepatobiliary disorders
Hyperbilirubinemia
|
0.00%
0/3 • From start of study treatment to day 59 (end of study)
|
33.3%
4/12 • From start of study treatment to day 59 (end of study)
|
58.3%
7/12 • From start of study treatment to day 59 (end of study)
|
33.3%
4/12 • From start of study treatment to day 59 (end of study)
|
16.7%
2/12 • From start of study treatment to day 59 (end of study)
|
16.7%
2/12 • From start of study treatment to day 59 (end of study)
|
|
Infections and infestations
Oral herpes
|
0.00%
0/3 • From start of study treatment to day 59 (end of study)
|
0.00%
0/12 • From start of study treatment to day 59 (end of study)
|
0.00%
0/12 • From start of study treatment to day 59 (end of study)
|
8.3%
1/12 • From start of study treatment to day 59 (end of study)
|
16.7%
2/12 • From start of study treatment to day 59 (end of study)
|
0.00%
0/12 • From start of study treatment to day 59 (end of study)
|
|
Investigations
Urobilin urine present
|
0.00%
0/3 • From start of study treatment to day 59 (end of study)
|
16.7%
2/12 • From start of study treatment to day 59 (end of study)
|
8.3%
1/12 • From start of study treatment to day 59 (end of study)
|
0.00%
0/12 • From start of study treatment to day 59 (end of study)
|
8.3%
1/12 • From start of study treatment to day 59 (end of study)
|
0.00%
0/12 • From start of study treatment to day 59 (end of study)
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/3 • From start of study treatment to day 59 (end of study)
|
8.3%
1/12 • From start of study treatment to day 59 (end of study)
|
0.00%
0/12 • From start of study treatment to day 59 (end of study)
|
0.00%
0/12 • From start of study treatment to day 59 (end of study)
|
8.3%
1/12 • From start of study treatment to day 59 (end of study)
|
0.00%
0/12 • From start of study treatment to day 59 (end of study)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • From start of study treatment to day 59 (end of study)
|
8.3%
1/12 • From start of study treatment to day 59 (end of study)
|
0.00%
0/12 • From start of study treatment to day 59 (end of study)
|
0.00%
0/12 • From start of study treatment to day 59 (end of study)
|
16.7%
2/12 • From start of study treatment to day 59 (end of study)
|
0.00%
0/12 • From start of study treatment to day 59 (end of study)
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/3 • From start of study treatment to day 59 (end of study)
|
0.00%
0/12 • From start of study treatment to day 59 (end of study)
|
8.3%
1/12 • From start of study treatment to day 59 (end of study)
|
8.3%
1/12 • From start of study treatment to day 59 (end of study)
|
0.00%
0/12 • From start of study treatment to day 59 (end of study)
|
0.00%
0/12 • From start of study treatment to day 59 (end of study)
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/3 • From start of study treatment to day 59 (end of study)
|
0.00%
0/12 • From start of study treatment to day 59 (end of study)
|
25.0%
3/12 • From start of study treatment to day 59 (end of study)
|
0.00%
0/12 • From start of study treatment to day 59 (end of study)
|
8.3%
1/12 • From start of study treatment to day 59 (end of study)
|
25.0%
3/12 • From start of study treatment to day 59 (end of study)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • From start of study treatment to day 59 (end of study)
|
33.3%
4/12 • From start of study treatment to day 59 (end of study)
|
25.0%
3/12 • From start of study treatment to day 59 (end of study)
|
25.0%
3/12 • From start of study treatment to day 59 (end of study)
|
33.3%
4/12 • From start of study treatment to day 59 (end of study)
|
16.7%
2/12 • From start of study treatment to day 59 (end of study)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
1/3 • From start of study treatment to day 59 (end of study)
|
33.3%
4/12 • From start of study treatment to day 59 (end of study)
|
25.0%
3/12 • From start of study treatment to day 59 (end of study)
|
25.0%
3/12 • From start of study treatment to day 59 (end of study)
|
33.3%
4/12 • From start of study treatment to day 59 (end of study)
|
16.7%
2/12 • From start of study treatment to day 59 (end of study)
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • From start of study treatment to day 59 (end of study)
|
66.7%
8/12 • From start of study treatment to day 59 (end of study)
|
8.3%
1/12 • From start of study treatment to day 59 (end of study)
|
16.7%
2/12 • From start of study treatment to day 59 (end of study)
|
58.3%
7/12 • From start of study treatment to day 59 (end of study)
|
25.0%
3/12 • From start of study treatment to day 59 (end of study)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • From start of study treatment to day 59 (end of study)
|
8.3%
1/12 • From start of study treatment to day 59 (end of study)
|
0.00%
0/12 • From start of study treatment to day 59 (end of study)
|
8.3%
1/12 • From start of study treatment to day 59 (end of study)
|
0.00%
0/12 • From start of study treatment to day 59 (end of study)
|
0.00%
0/12 • From start of study treatment to day 59 (end of study)
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • From start of study treatment to day 59 (end of study)
|
16.7%
2/12 • From start of study treatment to day 59 (end of study)
|
0.00%
0/12 • From start of study treatment to day 59 (end of study)
|
0.00%
0/12 • From start of study treatment to day 59 (end of study)
|
0.00%
0/12 • From start of study treatment to day 59 (end of study)
|
0.00%
0/12 • From start of study treatment to day 59 (end of study)
|
|
Skin and subcutaneous tissue disorders
Purritus
|
0.00%
0/3 • From start of study treatment to day 59 (end of study)
|
0.00%
0/12 • From start of study treatment to day 59 (end of study)
|
8.3%
1/12 • From start of study treatment to day 59 (end of study)
|
0.00%
0/12 • From start of study treatment to day 59 (end of study)
|
8.3%
1/12 • From start of study treatment to day 59 (end of study)
|
0.00%
0/12 • From start of study treatment to day 59 (end of study)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place