Trial Outcomes & Findings for Antiviral Activity and Safety of 3 Different Doses of Mifepristone in Hepatitis C Infected Patients (NCT NCT00255177)
NCT ID: NCT00255177
Last Updated: 2009-11-03
Results Overview
Mean log change in HCV RNA viral load (significant reduction is considered \>0.5 log 10) from baseline (Day 1) following once or twice daily dosing for 28 days at the 28 day timepoint
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
44 participants
Primary outcome timeframe
Baseline (Day 1) to Day 28
Results posted on
2009-11-03
Participant Flow
Participant milestones
| Measure |
Placebo
|
VGX-410 150mg Daily
|
VGX-410 300mg Daily
|
VGX-410 300mg Twice Daily
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
14
|
13
|
6
|
|
Overall Study
COMPLETED
|
9
|
13
|
12
|
4
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Antiviral Activity and Safety of 3 Different Doses of Mifepristone in Hepatitis C Infected Patients
Baseline characteristics by cohort
| Measure |
Placebo
n=11 Participants
|
VGX-410 150mg Daily
n=14 Participants
|
VGX-410 300mg Daily
n=13 Participants
|
VGX-410 300mg Twice Daily
n=6 Participants
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
48.0 years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
45.4 years
STANDARD_DEVIATION 6.9 • n=7 Participants
|
47.4 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
52.0 years
STANDARD_DEVIATION 3.7 • n=4 Participants
|
47.5 years
STANDARD_DEVIATION 6.7 • n=21 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
14 participants
n=7 Participants
|
13 participants
n=5 Participants
|
6 participants
n=4 Participants
|
44 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) to Day 28Mean log change in HCV RNA viral load (significant reduction is considered \>0.5 log 10) from baseline (Day 1) following once or twice daily dosing for 28 days at the 28 day timepoint
Outcome measures
| Measure |
Placebo
n=9 Participants
|
VGX-410 150mg Daily
n=14 Participants
|
VGX-410 300mg Daily
n=11 Participants
|
VGX-410 300mg Twice Daily
n=6 Participants
|
|---|---|---|---|---|
|
Mean Log Change in Viral Load From Baseline (Day 1) to Day 28
|
0.30 copies/mL on log scale
Standard Deviation 0.45
|
0.00 copies/mL on log scale
Standard Deviation 0.30
|
0.18 copies/mL on log scale
Standard Deviation 0.32
|
0.04 copies/mL on log scale
Standard Deviation 0.39
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
VGX-410 150mg Daily
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
VGX-410 300mg Daily
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
VGX-410 300mg Twice Daily
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=11 participants at risk
|
VGX-410 150mg Daily
n=14 participants at risk
|
VGX-410 300mg Daily
n=13 participants at risk
|
VGX-410 300mg Twice Daily
n=6 participants at risk
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Generalized Rash
|
0.00%
0/11 • AEs that occurred during treatment period (Days 1-28)
|
0.00%
0/11 • AEs that occurred during treatment period (Days 1-28)
|
7.7%
1/13 • Number of events 1 • AEs that occurred during treatment period (Days 1-28)
|
0.00%
0/6 • AEs that occurred during treatment period (Days 1-28)
|
Other adverse events
| Measure |
Placebo
n=11 participants at risk
|
VGX-410 150mg Daily
n=14 participants at risk
|
VGX-410 300mg Daily
n=13 participants at risk
|
VGX-410 300mg Twice Daily
n=6 participants at risk
|
|---|---|---|---|---|
|
Ear and labyrinth disorders
Ear and Labyrinth Disorders
|
0.00%
0/11 • AEs that occurred during treatment period (Days 1-28)
|
7.1%
1/14 • AEs that occurred during treatment period (Days 1-28)
|
0.00%
0/13 • AEs that occurred during treatment period (Days 1-28)
|
0.00%
0/6 • AEs that occurred during treatment period (Days 1-28)
|
|
Eye disorders
Eye Disorders
|
0.00%
0/11 • AEs that occurred during treatment period (Days 1-28)
|
7.1%
1/14 • AEs that occurred during treatment period (Days 1-28)
|
23.1%
3/13 • AEs that occurred during treatment period (Days 1-28)
|
0.00%
0/6 • AEs that occurred during treatment period (Days 1-28)
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/11 • AEs that occurred during treatment period (Days 1-28)
|
0.00%
0/14 • AEs that occurred during treatment period (Days 1-28)
|
23.1%
3/13 • AEs that occurred during treatment period (Days 1-28)
|
0.00%
0/6 • AEs that occurred during treatment period (Days 1-28)
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/11 • AEs that occurred during treatment period (Days 1-28)
|
7.1%
1/14 • AEs that occurred during treatment period (Days 1-28)
|
15.4%
2/13 • AEs that occurred during treatment period (Days 1-28)
|
0.00%
0/6 • AEs that occurred during treatment period (Days 1-28)
|
|
Gastrointestinal disorders
Diarrhoea
|
9.1%
1/11 • AEs that occurred during treatment period (Days 1-28)
|
14.3%
2/14 • AEs that occurred during treatment period (Days 1-28)
|
0.00%
0/13 • AEs that occurred during treatment period (Days 1-28)
|
0.00%
0/6 • AEs that occurred during treatment period (Days 1-28)
|
|
Gastrointestinal disorders
Dry Mouth
|
9.1%
1/11 • AEs that occurred during treatment period (Days 1-28)
|
14.3%
2/14 • AEs that occurred during treatment period (Days 1-28)
|
23.1%
3/13 • AEs that occurred during treatment period (Days 1-28)
|
16.7%
1/6 • AEs that occurred during treatment period (Days 1-28)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/11 • AEs that occurred during treatment period (Days 1-28)
|
28.6%
4/14 • AEs that occurred during treatment period (Days 1-28)
|
38.5%
5/13 • AEs that occurred during treatment period (Days 1-28)
|
33.3%
2/6 • AEs that occurred during treatment period (Days 1-28)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/11 • AEs that occurred during treatment period (Days 1-28)
|
21.4%
3/14 • AEs that occurred during treatment period (Days 1-28)
|
7.7%
1/13 • AEs that occurred during treatment period (Days 1-28)
|
16.7%
1/6 • AEs that occurred during treatment period (Days 1-28)
|
|
General disorders
Fatigue
|
27.3%
3/11 • AEs that occurred during treatment period (Days 1-28)
|
42.9%
6/14 • AEs that occurred during treatment period (Days 1-28)
|
23.1%
3/13 • AEs that occurred during treatment period (Days 1-28)
|
16.7%
1/6 • AEs that occurred during treatment period (Days 1-28)
|
|
General disorders
Oedema Peripheral
|
0.00%
0/11 • AEs that occurred during treatment period (Days 1-28)
|
14.3%
2/14 • AEs that occurred during treatment period (Days 1-28)
|
15.4%
2/13 • AEs that occurred during treatment period (Days 1-28)
|
0.00%
0/6 • AEs that occurred during treatment period (Days 1-28)
|
|
Immune system disorders
Immune System Disorders
|
9.1%
1/11 • AEs that occurred during treatment period (Days 1-28)
|
0.00%
0/14 • AEs that occurred during treatment period (Days 1-28)
|
0.00%
0/13 • AEs that occurred during treatment period (Days 1-28)
|
0.00%
0/6 • AEs that occurred during treatment period (Days 1-28)
|
|
Infections and infestations
Infections and Infestations
|
18.2%
2/11 • AEs that occurred during treatment period (Days 1-28)
|
0.00%
0/14 • AEs that occurred during treatment period (Days 1-28)
|
7.7%
1/13 • AEs that occurred during treatment period (Days 1-28)
|
0.00%
0/6 • AEs that occurred during treatment period (Days 1-28)
|
|
Injury, poisoning and procedural complications
Injury, Poisoning and Procedural Complications
|
0.00%
0/11 • AEs that occurred during treatment period (Days 1-28)
|
14.3%
2/14 • AEs that occurred during treatment period (Days 1-28)
|
0.00%
0/13 • AEs that occurred during treatment period (Days 1-28)
|
0.00%
0/6 • AEs that occurred during treatment period (Days 1-28)
|
|
Investigations
Alanine Aminotransferase Increased
|
72.7%
8/11 • AEs that occurred during treatment period (Days 1-28)
|
57.1%
8/14 • AEs that occurred during treatment period (Days 1-28)
|
69.2%
9/13 • AEs that occurred during treatment period (Days 1-28)
|
66.7%
4/6 • AEs that occurred during treatment period (Days 1-28)
|
|
Investigations
Aspartate Aminotransferase Increased
|
54.5%
6/11 • AEs that occurred during treatment period (Days 1-28)
|
57.1%
8/14 • AEs that occurred during treatment period (Days 1-28)
|
69.2%
9/13 • AEs that occurred during treatment period (Days 1-28)
|
83.3%
5/6 • AEs that occurred during treatment period (Days 1-28)
|
|
Investigations
Blood Albumin Abnormal
|
9.1%
1/11 • AEs that occurred during treatment period (Days 1-28)
|
7.1%
1/14 • AEs that occurred during treatment period (Days 1-28)
|
15.4%
2/13 • AEs that occurred during treatment period (Days 1-28)
|
16.7%
1/6 • AEs that occurred during treatment period (Days 1-28)
|
|
Investigations
Blood Bilirubin Increased
|
0.00%
0/11 • AEs that occurred during treatment period (Days 1-28)
|
7.1%
1/14 • AEs that occurred during treatment period (Days 1-28)
|
7.7%
1/13 • AEs that occurred during treatment period (Days 1-28)
|
33.3%
2/6 • AEs that occurred during treatment period (Days 1-28)
|
|
Investigations
Blood Cholesterol Abnormal
|
9.1%
1/11 • AEs that occurred during treatment period (Days 1-28)
|
21.4%
3/14 • AEs that occurred during treatment period (Days 1-28)
|
7.7%
1/13 • AEs that occurred during treatment period (Days 1-28)
|
16.7%
1/6 • AEs that occurred during treatment period (Days 1-28)
|
|
Investigations
Blood Glucose Abnormal
|
63.6%
7/11 • AEs that occurred during treatment period (Days 1-28)
|
57.1%
8/14 • AEs that occurred during treatment period (Days 1-28)
|
61.5%
8/13 • AEs that occurred during treatment period (Days 1-28)
|
66.7%
4/6 • AEs that occurred during treatment period (Days 1-28)
|
|
Investigations
Blood Glucose Increased
|
9.1%
1/11 • AEs that occurred during treatment period (Days 1-28)
|
7.1%
1/14 • AEs that occurred during treatment period (Days 1-28)
|
0.00%
0/13 • AEs that occurred during treatment period (Days 1-28)
|
16.7%
1/6 • AEs that occurred during treatment period (Days 1-28)
|
|
Investigations
Blood Potassium Increased
|
9.1%
1/11 • AEs that occurred during treatment period (Days 1-28)
|
7.1%
1/14 • AEs that occurred during treatment period (Days 1-28)
|
0.00%
0/13 • AEs that occurred during treatment period (Days 1-28)
|
16.7%
1/6 • AEs that occurred during treatment period (Days 1-28)
|
|
Investigations
Blood Triglycerides Abnormal
|
9.1%
1/11 • AEs that occurred during treatment period (Days 1-28)
|
14.3%
2/14 • AEs that occurred during treatment period (Days 1-28)
|
0.00%
0/13 • AEs that occurred during treatment period (Days 1-28)
|
0.00%
0/6 • AEs that occurred during treatment period (Days 1-28)
|
|
Investigations
Haemoglobin Decreased
|
18.2%
2/11 • AEs that occurred during treatment period (Days 1-28)
|
14.3%
2/14 • AEs that occurred during treatment period (Days 1-28)
|
15.4%
2/13 • AEs that occurred during treatment period (Days 1-28)
|
0.00%
0/6 • AEs that occurred during treatment period (Days 1-28)
|
|
Investigations
Neutrophil Count Decreased
|
18.2%
2/11 • AEs that occurred during treatment period (Days 1-28)
|
14.3%
2/14 • AEs that occurred during treatment period (Days 1-28)
|
15.4%
2/13 • AEs that occurred during treatment period (Days 1-28)
|
16.7%
1/6 • AEs that occurred during treatment period (Days 1-28)
|
|
Investigations
Platelet Count Decreased
|
9.1%
1/11 • AEs that occurred during treatment period (Days 1-28)
|
7.1%
1/14 • AEs that occurred during treatment period (Days 1-28)
|
23.1%
3/13 • AEs that occurred during treatment period (Days 1-28)
|
16.7%
1/6 • AEs that occurred during treatment period (Days 1-28)
|
|
Investigations
White Blood Cell Count Decreased
|
18.2%
2/11 • AEs that occurred during treatment period (Days 1-28)
|
14.3%
2/14 • AEs that occurred during treatment period (Days 1-28)
|
0.00%
0/13 • AEs that occurred during treatment period (Days 1-28)
|
33.3%
2/6 • AEs that occurred during treatment period (Days 1-28)
|
|
Metabolism and nutrition disorders
Metabolism and Nutrition Disorders
|
9.1%
1/11 • AEs that occurred during treatment period (Days 1-28)
|
0.00%
0/14 • AEs that occurred during treatment period (Days 1-28)
|
7.7%
1/13 • AEs that occurred during treatment period (Days 1-28)
|
0.00%
0/6 • AEs that occurred during treatment period (Days 1-28)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and Connective Tissue Disorders
|
18.2%
2/11 • AEs that occurred during treatment period (Days 1-28)
|
28.6%
4/14 • AEs that occurred during treatment period (Days 1-28)
|
23.1%
3/13 • AEs that occurred during treatment period (Days 1-28)
|
0.00%
0/6 • AEs that occurred during treatment period (Days 1-28)
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
9.1%
1/11 • AEs that occurred during treatment period (Days 1-28)
|
7.1%
1/14 • AEs that occurred during treatment period (Days 1-28)
|
7.7%
1/13 • AEs that occurred during treatment period (Days 1-28)
|
0.00%
0/6 • AEs that occurred during treatment period (Days 1-28)
|
|
Nervous system disorders
Dizziness
|
9.1%
1/11 • AEs that occurred during treatment period (Days 1-28)
|
21.4%
3/14 • AEs that occurred during treatment period (Days 1-28)
|
23.1%
3/13 • AEs that occurred during treatment period (Days 1-28)
|
0.00%
0/6 • AEs that occurred during treatment period (Days 1-28)
|
|
Nervous system disorders
Dizziness Postural
|
9.1%
1/11 • AEs that occurred during treatment period (Days 1-28)
|
7.1%
1/14 • AEs that occurred during treatment period (Days 1-28)
|
0.00%
0/13 • AEs that occurred during treatment period (Days 1-28)
|
16.7%
1/6 • AEs that occurred during treatment period (Days 1-28)
|
|
Nervous system disorders
Headache
|
27.3%
3/11 • AEs that occurred during treatment period (Days 1-28)
|
35.7%
5/14 • AEs that occurred during treatment period (Days 1-28)
|
15.4%
2/13 • AEs that occurred during treatment period (Days 1-28)
|
16.7%
1/6 • AEs that occurred during treatment period (Days 1-28)
|
|
Psychiatric disorders
Anxiety
|
9.1%
1/11 • AEs that occurred during treatment period (Days 1-28)
|
7.1%
1/14 • AEs that occurred during treatment period (Days 1-28)
|
7.7%
1/13 • AEs that occurred during treatment period (Days 1-28)
|
16.7%
1/6 • AEs that occurred during treatment period (Days 1-28)
|
|
Reproductive system and breast disorders
Reproductive System and Breast Disorders
|
0.00%
0/11 • AEs that occurred during treatment period (Days 1-28)
|
21.4%
3/14 • AEs that occurred during treatment period (Days 1-28)
|
15.4%
2/13 • AEs that occurred during treatment period (Days 1-28)
|
0.00%
0/6 • AEs that occurred during treatment period (Days 1-28)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/11 • AEs that occurred during treatment period (Days 1-28)
|
7.1%
1/14 • AEs that occurred during treatment period (Days 1-28)
|
7.7%
1/13 • AEs that occurred during treatment period (Days 1-28)
|
16.7%
1/6 • AEs that occurred during treatment period (Days 1-28)
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
9.1%
1/11 • AEs that occurred during treatment period (Days 1-28)
|
7.1%
1/14 • AEs that occurred during treatment period (Days 1-28)
|
15.4%
2/13 • AEs that occurred during treatment period (Days 1-28)
|
0.00%
0/6 • AEs that occurred during treatment period (Days 1-28)
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/11 • AEs that occurred during treatment period (Days 1-28)
|
14.3%
2/14 • AEs that occurred during treatment period (Days 1-28)
|
7.7%
1/13 • AEs that occurred during treatment period (Days 1-28)
|
16.7%
1/6 • AEs that occurred during treatment period (Days 1-28)
|
|
Surgical and medical procedures
Surgical and Medical Procedures
|
0.00%
0/11 • AEs that occurred during treatment period (Days 1-28)
|
0.00%
0/14 • AEs that occurred during treatment period (Days 1-28)
|
0.00%
0/13 • AEs that occurred during treatment period (Days 1-28)
|
16.7%
1/6 • AEs that occurred during treatment period (Days 1-28)
|
|
Vascular disorders
Hot Flush
|
9.1%
1/11 • AEs that occurred during treatment period (Days 1-28)
|
21.4%
3/14 • AEs that occurred during treatment period (Days 1-28)
|
7.7%
1/13 • AEs that occurred during treatment period (Days 1-28)
|
0.00%
0/6 • AEs that occurred during treatment period (Days 1-28)
|
|
Vascular disorders
Orthostatic Hypotension
|
9.1%
1/11 • AEs that occurred during treatment period (Days 1-28)
|
7.1%
1/14 • AEs that occurred during treatment period (Days 1-28)
|
7.7%
1/13 • AEs that occurred during treatment period (Days 1-28)
|
0.00%
0/6 • AEs that occurred during treatment period (Days 1-28)
|
Additional Information
Mary Giffear, Sr. Clinical Scientist
VGX Pharmaceuticals, LLC
Phone: 267 440 4220
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place