Trial Outcomes & Findings for Study of A Combination Pill With GS-7977 and GS-5885 for Hepatitis C in People With HIV (NCT NCT01878799)
NCT ID: NCT01878799
Last Updated: 2016-09-15
Results Overview
The primary end point was sustained virologic response \[plasma HCV RNA level \<12 IU/mL by real-time HCV assay (Abbott)\] at 12 weeks after treatment completion (SVR12) among all patients enrolled in the study.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
12 weeks after completion of treatment
Results posted on
2016-09-15
Participant Flow
Participant milestones
| Measure |
Subjects With HIV and HCV on Antiretroviral Agents
Subjects with HIV and HCV on antiretroviral agents given 'Drug: GS-7977 (sofosbuvir 400mg)/GS-5885 (ledipasvir 90mg) FDC' once daily by mouth for 12 weeks. The GS-7977/GS-5885 product combines a potent HCV nucleotide inhibitor and a potent HCV NS5A inhibitor.
|
Subjects With HIV and HCV Who Are Not on Antiretroviral Agents
Subjects with HIV and HCV not on antiretroviral agents given 'Drug: GS-7977 (sofosbuvir 400mg)/GS-5885 (ledipasvir 90mg) FDC' once daily by mouth for 12 weeks. The GS-7977/GS-5885 product combines a potent HCV nucleotide inhibitor and a potent HCV NS5A inhibitor.
|
|---|---|---|
|
Overall Study
STARTED
|
37
|
13
|
|
Overall Study
COMPLETED
|
36
|
13
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of A Combination Pill With GS-7977 and GS-5885 for Hepatitis C in People With HIV
Baseline characteristics by cohort
| Measure |
Subjects With HIV and HCV on Antiretroviral Agents
n=37 Participants
Subjects with HIV and HCV on antiretroviral agents given 'Drug: GS-7977 (sofosbuvir 400mg)/GS-5885 (ledipasvir 90mg) FDC' once daily by mouth for 12 weeks. The GS-7977/GS-5885 product combines a potent HCV nucleotide inhibitor and a potent HCV NS5A inhibitor.
|
Subjects With HIV and HCV Who Are Not on Antiretroviral Agents
n=13 Participants
Subjects with HIV and HCV who are not on antiretroviral agents given 'Drug: GS-7977 (sofosbuvir 400mg)/GS-5885 (ledipasvir 90mg) FDC' once daily by mouth for 12 weeks. The GS-7977/GS-5885 product combines a potent HCV nucleotide inhibitor and a potent HCV NS5A inhibitor.
|
Total
n=50 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
|
|
Age, Categorical
Between 18 and 65 years
|
32 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
31 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 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
|
PRIMARY outcome
Timeframe: 12 weeks after completion of treatmentPopulation: The analysis included all subjects who received at least one dose of study treatment.
The primary end point was sustained virologic response \[plasma HCV RNA level \<12 IU/mL by real-time HCV assay (Abbott)\] at 12 weeks after treatment completion (SVR12) among all patients enrolled in the study.
Outcome measures
| Measure |
Subjects With HIV and HCV on Antiretroviral Agents
n=37 Participants
Subjects with HIV and HCV on antiretroviral agents given 'Drug: GS-7977 (sofosbuvir 400mg)/GS-5885 (ledipasvir 90mg) FDC' once daily by mouth for 12 weeks. The GS-7977/GS-5885 product combines a potent HCV nucleotide inhibitor and a potent HCV NS5A inhibitor.
|
Subjects With HIV and HCV Who Are Not on Antiretroviral Agents
n=13 Participants
Subjects with HIV and HCV who are not on antiretroviral agents given 'Drug: GS-7977 (sofosbuvir 400mg)/GS-5885 (ledipasvir 90mg) FDC' once daily by mouth for 12 weeks. The GS-7977/GS-5885 product combines a potent HCV nucleotide inhibitor and a potent HCV NS5A inhibitor.
|
|---|---|---|
|
Percentage of Participants With Achieved SVR12 (HCV RNA <LLOQ 12 Weeks After Completion of Treatment)
|
97 percentage of participants
Interval 89.0 to 100.0
|
100 percentage of participants
Interval 75.0 to 100.0
|
Adverse Events
Subjects With HIV and HCV on Antiretroviral Agents
Serious events: 0 serious events
Other events: 36 other events
Deaths: 0 deaths
Subjects With HIV and HCV Who Are Not on Antiretroviral Agents
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Subjects With HIV and HCV on Antiretroviral Agents
n=37 participants at risk
Subjects with HIV and HCV on antiretroviral agents given 'Drug: GS-7977 (sofosbuvir 400mg)/GS-5885 (ledipasvir 90mg) FDC' once daily by mouth for 12 weeks. The GS-7977/GS-5885 product combines a potent HCV nucleotide inhibitor and a potent HCV NS5A inhibitor.
|
Subjects With HIV and HCV Who Are Not on Antiretroviral Agents
n=13 participants at risk
Subjects with HIV and HCV who are not on antiretroviral agents given 'Drug: GS-7977 (sofosbuvir 400mg)/GS-5885 (ledipasvir 90mg) FDC' once daily by mouth for 12 weeks. The GS-7977/GS-5885 product combines a potent HCV nucleotide inhibitor and a potent HCV NS5A inhibitor.
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/37 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
7.7%
1/13 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
Other adverse events
| Measure |
Subjects With HIV and HCV on Antiretroviral Agents
n=37 participants at risk
Subjects with HIV and HCV on antiretroviral agents given 'Drug: GS-7977 (sofosbuvir 400mg)/GS-5885 (ledipasvir 90mg) FDC' once daily by mouth for 12 weeks. The GS-7977/GS-5885 product combines a potent HCV nucleotide inhibitor and a potent HCV NS5A inhibitor.
|
Subjects With HIV and HCV Who Are Not on Antiretroviral Agents
n=13 participants at risk
Subjects with HIV and HCV who are not on antiretroviral agents given 'Drug: GS-7977 (sofosbuvir 400mg)/GS-5885 (ledipasvir 90mg) FDC' once daily by mouth for 12 weeks. The GS-7977/GS-5885 product combines a potent HCV nucleotide inhibitor and a potent HCV NS5A inhibitor.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/37 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
7.7%
1/13 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/37 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
7.7%
1/13 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
|
Gastrointestinal disorders
Diarrhoea
|
5.4%
2/37 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
15.4%
2/13 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/37 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
7.7%
1/13 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
|
Gastrointestinal disorders
Nausea
|
5.4%
2/37 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
7.7%
1/13 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
|
General disorders
Fatigue
|
5.4%
2/37 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
23.1%
3/13 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
|
General disorders
Pain
|
5.4%
2/37 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
23.1%
3/13 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/37 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
7.7%
1/13 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
|
Infections and infestations
Nasopharyngitis
|
10.8%
4/37 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
7.7%
1/13 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
|
Infections and infestations
Pneumonia
|
0.00%
0/37 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
7.7%
1/13 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
|
Infections and infestations
Tooth infection
|
0.00%
0/37 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
7.7%
1/13 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
|
Infections and infestations
Urinary tract infection
|
5.4%
2/37 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
0.00%
0/13 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/37 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
7.7%
1/13 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
|
Investigations
Alanine aminotransferase increased
|
18.9%
7/37 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
15.4%
2/13 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
|
Investigations
Amylase increased
|
35.1%
13/37 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
7.7%
1/13 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
|
Investigations
Aspartate aminotransferase increased
|
24.3%
9/37 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
23.1%
3/13 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
|
Investigations
Blood alkaline phosphatase increased
|
8.1%
3/37 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
0.00%
0/13 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
|
Investigations
Blood bicarbonate abnormal
|
5.4%
2/37 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
7.7%
1/13 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/37 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
15.4%
2/13 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
|
Investigations
Blood cholesterol increased
|
43.2%
16/37 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
38.5%
5/13 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
|
Investigations
Blood creatinine increased
|
16.2%
6/37 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
0.00%
0/13 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
|
Investigations
Hemoglobin decreased
|
10.8%
4/37 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
0.00%
0/13 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
|
Investigations
Lipase increased
|
13.5%
5/37 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
0.00%
0/13 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
|
Investigations
Low density lipoprotein increased
|
24.3%
9/37 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
23.1%
3/13 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
|
Investigations
Neutrophil count decreased
|
21.6%
8/37 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
38.5%
5/13 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
|
Investigations
Platelet count decreased
|
0.00%
0/37 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
7.7%
1/13 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
|
Investigations
White blood cell count decreased
|
5.4%
2/37 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
7.7%
1/13 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/37 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
7.7%
1/13 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
5.4%
2/37 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
7.7%
1/13 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
32.4%
12/37 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
69.2%
9/13 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/37 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
15.4%
2/13 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
5.4%
2/37 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
7.7%
1/13 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
29.7%
11/37 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
61.5%
8/13 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/37 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
7.7%
1/13 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
8.1%
3/37 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
7.7%
1/13 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.4%
2/37 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
7.7%
1/13 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/37 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
15.4%
2/13 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.4%
2/37 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
0.00%
0/13 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
24.3%
9/37 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
7.7%
1/13 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/37 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
7.7%
1/13 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.1%
3/37 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
7.7%
1/13 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/37 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
7.7%
1/13 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
|
Nervous system disorders
Headache
|
10.8%
4/37 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
7.7%
1/13 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
|
Nervous system disorders
Hypoesthesia
|
0.00%
0/37 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
7.7%
1/13 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
|
Nervous system disorders
Somnolence
|
0.00%
0/37 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
7.7%
1/13 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/37 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
7.7%
1/13 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/37 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
7.7%
1/13 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
|
Renal and urinary disorders
Proteinuria
|
2.7%
1/37 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
7.7%
1/13 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
|
Renal and urinary disorders
Renal disorder
|
0.00%
0/37 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
7.7%
1/13 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
5.4%
2/37 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
0.00%
0/13 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/37 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
7.7%
1/13 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/37 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
7.7%
1/13 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/37 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
7.7%
1/13 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.4%
2/37 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
0.00%
0/13 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
|
Social circumstances
Bereavement
|
0.00%
0/37 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
7.7%
1/13 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/37 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
7.7%
1/13 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
|
Vascular disorders
Hypertension
|
0.00%
0/37 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
7.7%
1/13 • On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
|
Additional Information
Dr. Shyam Kottilil
National Institute of Allergy and Infectious Diseases
Phone: +1 301 435 0936
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place