Trial Outcomes & Findings for Safety, Tolerability, and Efficacy of 12-weeks of Sovaprevir, ACH-3102, and Ribavirin in Treatment-naive GT-1 HCV Participants (NCT NCT01849562)
NCT ID: NCT01849562
Last Updated: 2023-08-29
Results Overview
Incidence of SVR4 after the completion of dosing, reported as hepatitis C virus (HCV) ribonucleic acid less than the lower limit of quantification, in participants who received active treatment (sovaprevir and ACH-0143102 in combination with RBV) as compared to those who received placebo.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
Four weeks after the completion of treatment
Results posted on
2023-08-29
Participant Flow
Participants were recruited from 7 sites in the United States and 1 site in Canada between 07 May 2013 and 04 April 2014.
Participants were screened within 4 weeks (-28 to -1 days) before administration of the study drug. Participants who meet all eligibility criteria were instructed to arrive at the study center on baseline day.
Participant milestones
| Measure |
Sovaprevir 200 mg, ACH-3102 150/50 mg, RBV 1000-1200 mg
Sovaprevir 200 milligrams (mg) once daily (qd) + ACH-3102 150 mg loading dose on Day 1, followed by 50 mg qd + ribavirin (RBV) weight-based 1000-1200mg qd for 12 weeks.
|
Sovaprevir 400 mg, ACH-3102 150/50 mg, RBV 1000-1200 mg
Sovaprevir 400 mg qd + ACH-3102 150 mg loading dose on Day 1, followed by 50 mg qd + RBV weight-based 1000-1200 mg qd for 12 weeks.
|
Placebo
Placebo for sovaprevir capsule qd + placebo for ACH-3102 150 mg loading dose on Day 1, followed by placebo for 50 mg qd + placebo for weight-based RBV qd for 12 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
8
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
0
|
Reasons for withdrawal
| Measure |
Sovaprevir 200 mg, ACH-3102 150/50 mg, RBV 1000-1200 mg
Sovaprevir 200 milligrams (mg) once daily (qd) + ACH-3102 150 mg loading dose on Day 1, followed by 50 mg qd + ribavirin (RBV) weight-based 1000-1200mg qd for 12 weeks.
|
Sovaprevir 400 mg, ACH-3102 150/50 mg, RBV 1000-1200 mg
Sovaprevir 400 mg qd + ACH-3102 150 mg loading dose on Day 1, followed by 50 mg qd + RBV weight-based 1000-1200 mg qd for 12 weeks.
|
Placebo
Placebo for sovaprevir capsule qd + placebo for ACH-3102 150 mg loading dose on Day 1, followed by placebo for 50 mg qd + placebo for weight-based RBV qd for 12 weeks.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
|
Overall Study
Non-compliance with Study Drug
|
1
|
0
|
0
|
Baseline Characteristics
Safety, Tolerability, and Efficacy of 12-weeks of Sovaprevir, ACH-3102, and Ribavirin in Treatment-naive GT-1 HCV Participants
Baseline characteristics by cohort
| Measure |
Sovaprevir 200 mg, ACH-3102 150/50 mg, RBV 1000-1200 mg
n=10 Participants
Sovaprevir 200 mg qd + ACH-3102 150 mg loading dose on Day 1, followed by 50 mg qd + RBV weight-based 1000-1200 mg qd for 12 weeks.
|
Sovaprevir 400 mg, ACH-3102 150/50 mg, RBV 1000-1200 mg
n=10 Participants
Sovaprevir 400 mg qd + ACH-3102 150 mg loading dose on Day 1, followed by 50 mg qd + RBV weight-based 1000-1200 mg qd for 12 weeks.
|
Placebo
n=10 Participants
Placebo for sovaprevir capsule qd + placebo for ACH-3102 150 mg loading dose on Day 1 followed, by placebo for 50 mg qd + placebo for weight-based RBV qd for 12 weeks.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Age, Continuous
|
50.5 Years
STANDARD_DEVIATION 11.36 • n=5 Participants
|
50.7 Years
STANDARD_DEVIATION 8.51 • n=7 Participants
|
53.8 Years
STANDARD_DEVIATION 8.58 • n=5 Participants
|
51.7 Years
STANDARD_DEVIATION 9.4 • n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Weight
|
78.1 Kilograms
STANDARD_DEVIATION 15.02 • n=5 Participants
|
81.5 Kilograms
STANDARD_DEVIATION 9.88 • n=7 Participants
|
81.5 Kilograms
STANDARD_DEVIATION 11.9 • n=5 Participants
|
80.2 Kilograms
STANDARD_DEVIATION 12.1 • n=4 Participants
|
|
Height
|
170.1 Centimeters
STANDARD_DEVIATION 11.14 • n=5 Participants
|
169.7 Centimeters
STANDARD_DEVIATION 9.76 • n=7 Participants
|
175.6 Centimeters
STANDARD_DEVIATION 7.53 • n=5 Participants
|
171.8 Centimeters
STANDARD_DEVIATION 9.66 • n=4 Participants
|
PRIMARY outcome
Timeframe: Four weeks after the completion of treatmentPopulation: The analysis population for SVR4 was the full analysis (FA) set, defined as all randomized participants who received at least 1 dose of the study drug and had at least 1 baseline/post HCV RNA assessment. For this study, the FA set and the safety population were the same.
Incidence of SVR4 after the completion of dosing, reported as hepatitis C virus (HCV) ribonucleic acid less than the lower limit of quantification, in participants who received active treatment (sovaprevir and ACH-0143102 in combination with RBV) as compared to those who received placebo.
Outcome measures
| Measure |
Sovaprevir 200 mg, ACH-3102 150/50 mg, RBV 1000-1200 mg
n=10 Participants
Sovaprevir 200 mg qd + ACH-3102 150 mg loading dose on Day 1, followed by 50 mg qd + RBV weight-based 1000-1200 mg qd for 12 weeks.
|
Sovaprevir 400 mg, ACH-3102 150/50 mg, RBV 1000-1200 mg
n=10 Participants
Sovaprevir 400 mg qd + ACH-3102 150 mg loading dose on Day 1, followed by 50 mg qd + RBV weight-based 1000-1200 mg qd for 12 weeks.
|
Placebo
n=10 Participants
Placebo for sovaprevir capsule qd + placebo for ACH-3102 150 mg loading dose on Day 1, followed by placebo for 50 mg qd + placebo for weight-based RBV qd for 12 weeks.
|
|---|---|---|---|
|
Incidence Of Sustained Virologic Response 4 Weeks (SVR4) After The Completion Of Treatment
|
50 Percentage of participants with SVR4
|
70 Percentage of participants with SVR4
|
0 Percentage of participants with SVR4
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: The analysis population for safety and tolerability was the safety population, defined as all randomized participants who received at least 1 dose of study drug. For this study, the safety population and the FA set were the same.
To determine the safety and tolerability of 12 weeks of sovaprevir/ACH-0143102/RBV treatment in participants with chronic genotype-1 (GT-1) HCV, the following criteria will be used: the number of participants with discontinuations due to adverse events (AEs), treatment-emergent Grade 3/Grade 4 (G3/G4) AEs, treatment-emergent G3/G4 laboratory abnormalities, and clinically significant electrocardiograms (ECGs).
Outcome measures
| Measure |
Sovaprevir 200 mg, ACH-3102 150/50 mg, RBV 1000-1200 mg
n=10 Participants
Sovaprevir 200 mg qd + ACH-3102 150 mg loading dose on Day 1, followed by 50 mg qd + RBV weight-based 1000-1200 mg qd for 12 weeks.
|
Sovaprevir 400 mg, ACH-3102 150/50 mg, RBV 1000-1200 mg
n=10 Participants
Sovaprevir 400 mg qd + ACH-3102 150 mg loading dose on Day 1, followed by 50 mg qd + RBV weight-based 1000-1200 mg qd for 12 weeks.
|
Placebo
n=10 Participants
Placebo for sovaprevir capsule qd + placebo for ACH-3102 150 mg loading dose on Day 1, followed by placebo for 50 mg qd + placebo for weight-based RBV qd for 12 weeks.
|
|---|---|---|---|
|
Safety And Tolerability Of 12 Weeks Of Sovaprevir And ACH-3102 In Combination With RBV In GT-1 HCV Participants
Discontinuations due to AEs
|
0 participants
|
0 participants
|
0 participants
|
|
Safety And Tolerability Of 12 Weeks Of Sovaprevir And ACH-3102 In Combination With RBV In GT-1 HCV Participants
Treatment Emergent G3/G4 AEs
|
0 participants
|
0 participants
|
0 participants
|
|
Safety And Tolerability Of 12 Weeks Of Sovaprevir And ACH-3102 In Combination With RBV In GT-1 HCV Participants
Treatment Emergent G3/G4 Abnormalities
|
3 participants
|
2 participants
|
0 participants
|
|
Safety And Tolerability Of 12 Weeks Of Sovaprevir And ACH-3102 In Combination With RBV In GT-1 HCV Participants
Clinically Significant ECGs
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
Sovaprevir 200 mg, ACH-3102 150/50 mg, RBV 1000-1200 mg
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Sovaprevir 400 mg, ACH-3102 150/50 mg, RBV 1000-1200 mg
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sovaprevir 200 mg, ACH-3102 150/50 mg, RBV 1000-1200 mg
n=10 participants at risk
Sovaprevir 200 mg qd + ACH-3102 150 mg loading dose on Day 1, followed by 50 mg qd + RBV weight-based 1000-1200 mg qd for 12 weeks.
|
Sovaprevir 400 mg, ACH-3102 150/50 mg, RBV 1000-1200 mg
n=10 participants at risk
Sovaprevir 400 mg qd + ACH-3102 150 mg loading dose on Day 1, followed by 50 mg qd + RBV weight-based 1000-1200 mg qd for 12 weeks.
|
Placebo
n=10 participants at risk
Placebo for sovaprevir capsule qd + placebo for ACH-3102 150 mg loading dose on Day 1, followed by placebo for 50 mg qd + placebo for weight-based RBV qd for 12 weeks.
|
|---|---|---|---|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
10.0%
1/10 • Number of events 1 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
Other adverse events
| Measure |
Sovaprevir 200 mg, ACH-3102 150/50 mg, RBV 1000-1200 mg
n=10 participants at risk
Sovaprevir 200 mg qd + ACH-3102 150 mg loading dose on Day 1, followed by 50 mg qd + RBV weight-based 1000-1200 mg qd for 12 weeks.
|
Sovaprevir 400 mg, ACH-3102 150/50 mg, RBV 1000-1200 mg
n=10 participants at risk
Sovaprevir 400 mg qd + ACH-3102 150 mg loading dose on Day 1, followed by 50 mg qd + RBV weight-based 1000-1200 mg qd for 12 weeks.
|
Placebo
n=10 participants at risk
Placebo for sovaprevir capsule qd + placebo for ACH-3102 150 mg loading dose on Day 1, followed by placebo for 50 mg qd + placebo for weight-based RBV qd for 12 weeks.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
20.0%
2/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
30.0%
3/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
10.0%
1/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
10.0%
1/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
|
Ear and labyrinth disorders
Tinnitus
|
10.0%
1/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
10.0%
1/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
|
Eye disorders
Vision blurred
|
10.0%
1/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
1/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
10.0%
1/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
|
Gastrointestinal disorders
Diarrhoea
|
10.0%
1/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
10.0%
1/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
20.0%
2/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
|
Gastrointestinal disorders
Dyspepsia
|
10.0%
1/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
10.0%
1/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
10.0%
1/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
|
Gastrointestinal disorders
Nausea
|
30.0%
3/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
30.0%
3/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
|
Gastrointestinal disorders
Odynophagia
|
10.0%
1/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
2/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
10.0%
1/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
|
General disorders
Chest pain
|
10.0%
1/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
|
General disorders
Fatigue
|
20.0%
2/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
30.0%
3/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
40.0%
4/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
|
General disorders
Influenza like illness
|
10.0%
1/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
10.0%
1/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
|
General disorders
Irritability
|
20.0%
2/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
10.0%
1/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
|
General disorders
Oedema peripheral
|
10.0%
1/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
|
General disorders
Temperature intolerance
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
10.0%
1/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
|
Infections and infestations
Bronchitis
|
10.0%
1/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
|
Infections and infestations
Cellulitis
|
10.0%
1/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
|
Infections and infestations
Oral herpes
|
10.0%
1/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
|
Infections and infestations
Sinusitis
|
10.0%
1/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
|
Infections and infestations
Tinea cruris
|
10.0%
1/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
10.0%
1/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
10.0%
1/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
|
Infections and infestations
Upper respiratory tract infection
|
20.0%
2/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
20.0%
2/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
10.0%
1/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
|
Infections and infestations
Urinary tract infection
|
10.0%
1/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/4 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
25.0%
1/4 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/4 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
10.0%
1/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.0%
1/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
2/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
10.0%
1/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
30.0%
3/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
10.0%
1/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
10.0%
1/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.0%
2/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
10.0%
1/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
10.0%
1/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.0%
1/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
10.0%
1/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
|
Nervous system disorders
Dizziness
|
10.0%
1/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
10.0%
1/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
|
Nervous system disorders
Dysgeusia
|
10.0%
1/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
|
Nervous system disorders
Headache
|
20.0%
2/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
40.0%
4/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
10.0%
1/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
10.0%
1/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
10.0%
1/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
20.0%
2/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
10.0%
1/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
10.0%
1/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/4 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/4 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
25.0%
1/4 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
2/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
20.0%
2/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
10.0%
1/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
10.0%
1/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
10.0%
1/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
10.0%
1/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
|
Skin and subcutaneous tissue disorders
Acne
|
10.0%
1/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
|
Skin and subcutaneous tissue disorders
Macule
|
10.0%
1/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
10.0%
1/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
10.0%
1/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
10.0%
1/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
20.0%
2/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
|
Vascular disorders
Haematoma
|
10.0%
1/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
|
Vascular disorders
Hypertension
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
10.0%
1/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
|
Vascular disorders
Hypotension
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
0.00%
0/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
10.0%
1/10 • AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were summarized.
|
Additional Information
Alexion Pharmaceuticals Inc.
Alexion Pharmaceuticals Inc.
Phone: 855-752-2356
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Prior to submitting/presenting a manuscript or materials relating to a Study to a publisher, reviewer, or outside person, the Institution shall provide to Sponsor a copy of all such manuscripts or materials, and Sponsor shall have thirty (30) days to review and comment. The Institution shall, upon Sponsor's request, further delay publication or presentation for a period of up to sixty (60) days to allow Sponsor to protect its interests in any Sponsor Inventions.
- Publication restrictions are in place
Restriction type: OTHER