Trial Outcomes & Findings for Double-Blind, Dose-Escalation Study of IDX184 in Chronic Hepatitis C Treatment-Naïve Subjects (NCT NCT00807001)
NCT ID: NCT00807001
Last Updated: 2016-08-19
Results Overview
Monitoring of adverse events, physical examination, routine safety laboratory parameters and electrocardiograms. 1=mild, 2=moderate, 3=severe, 4=potentially life-threatening
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
41 participants
Primary outcome timeframe
17 days
Results posted on
2016-08-19
Participant Flow
Participant milestones
| Measure |
Placebo
|
IDX184 25 mg
|
IDX184 50 mg
|
IDX184 75 mg
|
IDX184 100 mg
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
8
|
9
|
|
Overall Study
COMPLETED
|
8
|
7
|
8
|
8
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo
|
IDX184 25 mg
|
IDX184 50 mg
|
IDX184 75 mg
|
IDX184 100 mg
|
|---|---|---|---|---|---|
|
Overall Study
Non-compliance
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Double-Blind, Dose-Escalation Study of IDX184 in Chronic Hepatitis C Treatment-Naïve Subjects
Baseline characteristics by cohort
| Measure |
Placebo
n=8 Participants
|
IDX184 25 mg
n=8 Participants
|
IDX184 50 mg
n=8 Participants
|
IDX184 75 mg
n=8 Participants
|
IDX184 100 mg
n=9 Participants
|
Total
n=41 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
41 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Age, Continuous
|
49.3 years
STANDARD_DEVIATION 7.63 • n=5 Participants
|
48.3 years
STANDARD_DEVIATION 6.50 • n=7 Participants
|
48.8 years
STANDARD_DEVIATION 5.85 • n=5 Participants
|
47.3 years
STANDARD_DEVIATION 8.12 • n=4 Participants
|
47.2 years
STANDARD_DEVIATION 7.89 • n=21 Participants
|
48.1 years
STANDARD_DEVIATION 6.94 • n=8 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
29 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
8 participants
n=7 Participants
|
8 participants
n=5 Participants
|
7 participants
n=4 Participants
|
7 participants
n=21 Participants
|
36 participants
n=8 Participants
|
|
Region of Enrollment
Argentina
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
3 participants
n=8 Participants
|
|
Region of Enrollment
Austria
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
2 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 17 daysPopulation: Safety population consisted of all subjects who received at least one dose of study drug.
Monitoring of adverse events, physical examination, routine safety laboratory parameters and electrocardiograms. 1=mild, 2=moderate, 3=severe, 4=potentially life-threatening
Outcome measures
| Measure |
Placebo
n=8 Participants
|
IDX184 25 mg
n=8 Participants
|
IDX184 50 mg
n=8 Participants
|
IDX184 75 mg
n=8 Participants
|
IDX184 100 mg
n=9 Participants
|
|---|---|---|---|---|---|
|
Number of Subjects With Any Adverse Event (Side Effect) and the Severity of Those Adverse Events
Number of subjects with any adverse event
|
5 participants
|
2 participants
|
3 participants
|
3 participants
|
5 participants
|
|
Number of Subjects With Any Adverse Event (Side Effect) and the Severity of Those Adverse Events
Number of sub. with any Grade 3/4 lab abnormality
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
2 participants
|
|
Number of Subjects With Any Adverse Event (Side Effect) and the Severity of Those Adverse Events
Grade 3/4 Triacylglycerol Lipase, high
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Subjects With Any Adverse Event (Side Effect) and the Severity of Those Adverse Events
Grade 3/4 Prothrombin Intl. Normalized Ratio, high
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Subjects With Any Adverse Event (Side Effect) and the Severity of Those Adverse Events
Grade 3/4 Prothrombin Time, high
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Subjects With Any Adverse Event (Side Effect) and the Severity of Those Adverse Events
Grade 3/4 Urine Erythrocytes, high
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Subjects With Any Adverse Event (Side Effect) and the Severity of Those Adverse Events
Grade 3/4 Pancreatic Amylase, high
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline to 4 daysPopulation: efficacy evaluable population = a) must have received all 3 doses of study drug b) must have baseline and at least one post-baseline HCV RNA determination
Measures how much virus is in the blood.
Outcome measures
| Measure |
Placebo
n=8 Participants
|
IDX184 25 mg
n=6 Participants
|
IDX184 50 mg
n=8 Participants
|
IDX184 75 mg
n=7 Participants
|
IDX184 100 mg
n=9 Participants
|
|---|---|---|---|---|---|
|
Antiviral Activity at Day 4. Change in Plasma HCV RNA (Hepatitis C Virus Ribonucleic Acid)
|
-0.1 log10 IU/mL
Standard Deviation 0.3
|
-0.5 log10 IU/mL
Standard Deviation 0.6
|
-0.7 log10 IU/mL
Standard Deviation 0.2
|
-0.6 log10 IU/mL
Standard Deviation 0.3
|
-0.7 log10 IU/mL
Standard Deviation 0.5
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
IDX184 25 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
IDX184 50 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
IDX184 75 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
IDX184 100 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=8 participants at risk
|
IDX184 25 mg
n=8 participants at risk
|
IDX184 50 mg
n=8 participants at risk
|
IDX184 75 mg
n=8 participants at risk
|
IDX184 100 mg
n=9 participants at risk
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
1/8 • 17 days
|
0.00%
0/8 • 17 days
|
12.5%
1/8 • 17 days
|
0.00%
0/8 • 17 days
|
0.00%
0/9 • 17 days
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/8 • 17 days
|
0.00%
0/8 • 17 days
|
0.00%
0/8 • 17 days
|
12.5%
1/8 • 17 days
|
0.00%
0/9 • 17 days
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • 17 days
|
0.00%
0/8 • 17 days
|
12.5%
1/8 • 17 days
|
0.00%
0/8 • 17 days
|
0.00%
0/9 • 17 days
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/8 • 17 days
|
12.5%
1/8 • 17 days
|
0.00%
0/8 • 17 days
|
0.00%
0/8 • 17 days
|
0.00%
0/9 • 17 days
|
|
General disorders
Fatigue
|
12.5%
1/8 • 17 days
|
0.00%
0/8 • 17 days
|
0.00%
0/8 • 17 days
|
0.00%
0/8 • 17 days
|
22.2%
2/9 • 17 days
|
|
General disorders
Pain
|
0.00%
0/8 • 17 days
|
0.00%
0/8 • 17 days
|
0.00%
0/8 • 17 days
|
12.5%
1/8 • 17 days
|
0.00%
0/9 • 17 days
|
|
General disorders
Pyrexia
|
0.00%
0/8 • 17 days
|
0.00%
0/8 • 17 days
|
12.5%
1/8 • 17 days
|
0.00%
0/8 • 17 days
|
0.00%
0/9 • 17 days
|
|
General disorders
Thirst
|
0.00%
0/8 • 17 days
|
0.00%
0/8 • 17 days
|
12.5%
1/8 • 17 days
|
0.00%
0/8 • 17 days
|
0.00%
0/9 • 17 days
|
|
Infections and infestations
Oral herpes
|
0.00%
0/8 • 17 days
|
0.00%
0/8 • 17 days
|
0.00%
0/8 • 17 days
|
12.5%
1/8 • 17 days
|
0.00%
0/9 • 17 days
|
|
Investigations
Lipase increased
|
0.00%
0/8 • 17 days
|
12.5%
1/8 • 17 days
|
0.00%
0/8 • 17 days
|
0.00%
0/8 • 17 days
|
0.00%
0/9 • 17 days
|
|
Investigations
Urinary sediment present
|
0.00%
0/8 • 17 days
|
0.00%
0/8 • 17 days
|
0.00%
0/8 • 17 days
|
0.00%
0/8 • 17 days
|
11.1%
1/9 • 17 days
|
|
Investigations
Weight decreased
|
12.5%
1/8 • 17 days
|
0.00%
0/8 • 17 days
|
0.00%
0/8 • 17 days
|
0.00%
0/8 • 17 days
|
0.00%
0/9 • 17 days
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
12.5%
1/8 • 17 days
|
0.00%
0/8 • 17 days
|
0.00%
0/8 • 17 days
|
0.00%
0/8 • 17 days
|
0.00%
0/9 • 17 days
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
12.5%
1/8 • 17 days
|
0.00%
0/8 • 17 days
|
0.00%
0/8 • 17 days
|
0.00%
0/8 • 17 days
|
0.00%
0/9 • 17 days
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
12.5%
1/8 • 17 days
|
0.00%
0/8 • 17 days
|
0.00%
0/8 • 17 days
|
0.00%
0/8 • 17 days
|
0.00%
0/9 • 17 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/8 • 17 days
|
0.00%
0/8 • 17 days
|
0.00%
0/8 • 17 days
|
0.00%
0/8 • 17 days
|
11.1%
1/9 • 17 days
|
|
Nervous system disorders
Headache
|
12.5%
1/8 • 17 days
|
0.00%
0/8 • 17 days
|
12.5%
1/8 • 17 days
|
25.0%
2/8 • 17 days
|
11.1%
1/9 • 17 days
|
|
Nervous system disorders
Dizziness
|
12.5%
1/8 • 17 days
|
0.00%
0/8 • 17 days
|
0.00%
0/8 • 17 days
|
12.5%
1/8 • 17 days
|
0.00%
0/9 • 17 days
|
|
Nervous system disorders
Lethargy
|
0.00%
0/8 • 17 days
|
0.00%
0/8 • 17 days
|
12.5%
1/8 • 17 days
|
0.00%
0/8 • 17 days
|
0.00%
0/9 • 17 days
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/8 • 17 days
|
0.00%
0/8 • 17 days
|
0.00%
0/8 • 17 days
|
0.00%
0/8 • 17 days
|
11.1%
1/9 • 17 days
|
|
Psychiatric disorders
Depression
|
0.00%
0/8 • 17 days
|
12.5%
1/8 • 17 days
|
0.00%
0/8 • 17 days
|
0.00%
0/8 • 17 days
|
0.00%
0/9 • 17 days
|
|
Psychiatric disorders
Mood altered
|
12.5%
1/8 • 17 days
|
0.00%
0/8 • 17 days
|
0.00%
0/8 • 17 days
|
0.00%
0/8 • 17 days
|
0.00%
0/9 • 17 days
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/8 • 17 days
|
0.00%
0/8 • 17 days
|
0.00%
0/8 • 17 days
|
0.00%
0/8 • 17 days
|
11.1%
1/9 • 17 days
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/8 • 17 days
|
0.00%
0/8 • 17 days
|
0.00%
0/8 • 17 days
|
0.00%
0/8 • 17 days
|
11.1%
1/9 • 17 days
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/8 • 17 days
|
12.5%
1/8 • 17 days
|
0.00%
0/8 • 17 days
|
0.00%
0/8 • 17 days
|
0.00%
0/9 • 17 days
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/8 • 17 days
|
0.00%
0/8 • 17 days
|
0.00%
0/8 • 17 days
|
12.5%
1/8 • 17 days
|
0.00%
0/9 • 17 days
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/8 • 17 days
|
0.00%
0/8 • 17 days
|
0.00%
0/8 • 17 days
|
12.5%
1/8 • 17 days
|
0.00%
0/9 • 17 days
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/8 • 17 days
|
0.00%
0/8 • 17 days
|
0.00%
0/8 • 17 days
|
0.00%
0/8 • 17 days
|
11.1%
1/9 • 17 days
|
|
Skin and subcutaneous tissue disorders
Palmar erythema
|
0.00%
0/8 • 17 days
|
0.00%
0/8 • 17 days
|
0.00%
0/8 • 17 days
|
12.5%
1/8 • 17 days
|
0.00%
0/9 • 17 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.5%
1/8 • 17 days
|
0.00%
0/8 • 17 days
|
0.00%
0/8 • 17 days
|
0.00%
0/8 • 17 days
|
0.00%
0/9 • 17 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/8 • 17 days
|
0.00%
0/8 • 17 days
|
0.00%
0/8 • 17 days
|
0.00%
0/8 • 17 days
|
11.1%
1/9 • 17 days
|
|
Social circumstances
Menopause
|
0.00%
0/8 • 17 days
|
0.00%
0/8 • 17 days
|
0.00%
0/8 • 17 days
|
12.5%
1/8 • 17 days
|
0.00%
0/9 • 17 days
|
Additional Information
John Z. Sullivan-Bolyai, MD, MPH
Idenix Pharmaceuticals, Inc.
Phone: 877-433-6491
Results disclosure agreements
- Principal investigator is a sponsor employee Disclosure restriction on the PI that permits the sponsor to review results communications prior to public release and embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days from the time submitted to the sponsor for review. The sponsor may request the PI to remove the sponsor's confidential information prior to such publication.
- Publication restrictions are in place
Restriction type: OTHER