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| ID | Type | Description | Link |
|---|---|---|---|
| IDX-08C-003 |
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This is a proof-of-concept study which will provide data about the safety and antiviral activity of several doses of the investigational drug IDX184 given for 3 days in treatment-naive HCV genotype 1-infected subjects so that optimal doses can be chosen for testing in later studies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Experimental | Subjects randomized 8:2 (active:placebo) to receive one 25 milligrams (mg) capsule of IDX184 per day for 3 days. Fourteen days after treatment, subjects were offered a course of pegylated interferon and ribavirin according to local standard of care. |
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| Cohort B | Experimental | Subjects randomized 8:2 (active:placebo) to receive two 25 mg capsules of IDX184 per day for 3 days. Fourteen days after treatment, subjects were offered a course of pegylated interferon and ribavirin according to local standard of care. |
|
| Cohort C | Experimental | Subjects randomized 8:2 (active:placebo) to receive three 25 mg capsules of IDX184 per day for 3 days. Fourteen days after treatment, subjects were offered a course of pegylated interferon and ribavirin according to local standard of care. |
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| Cohort D | Experimental | Subjects randomized 8:2 (active:placebo) to receive four 25 mg capsules of IDX184 per day for 3 days. Fourteen days after treatment, subjects were offered a course of pegylated interferon and ribavirin according to local standard of care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IDX184 | Drug | oral dose, active or placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Any Adverse Event (Side Effect) and the Severity of Those Adverse Events | Monitoring of adverse events, physical examination, routine safety laboratory parameters and electrocardiograms. 1=mild, 2=moderate, 3=severe, 4=potentially life-threatening | 17 days |
| Measure | Description | Time Frame |
|---|---|---|
| Antiviral Activity at Day 4. Change in Plasma HCV RNA (Hepatitis C Virus Ribonucleic Acid) | Measures how much virus is in the blood. | Baseline to 4 days |
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Inclusion criteria:
Exclusion criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23070151 | Result | Lalezari J, Asmuth D, Casiro A, Vargas H, Lawrence S, Dubuc-Patrick G, Chen J, McCarville J, Pietropaolo K, Zhou XJ, Sullivan-Bolyai J, Mayers D. Short-term monotherapy with IDX184, a liver-targeted nucleotide polymerase inhibitor, in patients with chronic hepatitis C virus infection. Antimicrob Agents Chemother. 2012 Dec;56(12):6372-8. doi: 10.1128/AAC.01521-12. Epub 2012 Oct 15. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | |
| FG001 | IDX184 25 mg | |
| FG002 | IDX184 50 mg | |
| FG003 | IDX184 75 mg | |
| FG004 | IDX184 100 mg |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | |
| BG001 | IDX184 25 mg | |
| BG002 | IDX184 50 mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects With Any Adverse Event (Side Effect) and the Severity of Those Adverse Events | Monitoring of adverse events, physical examination, routine safety laboratory parameters and electrocardiograms. 1=mild, 2=moderate, 3=severe, 4=potentially life-threatening | Safety population consisted of all subjects who received at least one dose of study drug. | Posted | Number | participants | 17 days |
|
17 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
Adverse events summarized the 3 days of IDX184 dosing and 14 days of treatment free follow up.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Z. Sullivan-Bolyai, MD, MPH | Idenix Pharmaceuticals, Inc. | 877-433-6491 |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| C557801 | IDX184 |
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| BG003 | IDX184 75 mg |
| BG004 | IDX184 100 mg |
| BG005 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG003 |
| IDX184 75 mg |
| OG004 | IDX184 100 mg |
|
|
| Secondary | Antiviral Activity at Day 4. Change in Plasma HCV RNA (Hepatitis C Virus Ribonucleic Acid) | Measures how much virus is in the blood. | 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 | Posted | Mean | Standard Deviation | log10 IU/mL | Baseline to 4 days |
|
|
|
| 0 |
| 8 |
| 5 |
| 8 |
| EG001 | IDX184 25 mg | 0 | 8 | 2 | 8 |
| EG002 | IDX184 50 mg | 0 | 8 | 3 | 8 |
| EG003 | IDX184 75 mg | 0 | 8 | 3 | 8 |
| EG004 | IDX184 100 mg | 0 | 9 | 5 | 9 |
| Constipation | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Pain | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Thirst | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Oral herpes | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| Lipase increased | Investigations | MedDRA 11.0 | Systematic Assessment |
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| Urinary sediment present | Investigations | MedDRA 11.0 | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA 11.0 | Systematic Assessment |
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| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
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| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
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| Lethargy | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
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| Mood altered | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
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| Restlessness | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
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| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 11.0 | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Cold sweat | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| Palmar erythema | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| Menopause | Social circumstances | MedDRA 11.0 | Systematic Assessment |
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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.
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |