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| Name | Class |
|---|---|
| Achillion, a wholly owned subsidiary of Alexion | INDUSTRY |
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The purpose of this study was to evaluate the safety, tolerability, and efficacy of 12 weeks of treatment with ACH-0143102 and ribavirin in genotype 1b (GT1b), treatment-naive, hepatitis C virus (HCV) participants.
A Phase 1b, pilot study that evaluated the safety, tolerability, and antiviral activity of oral ACH-0143102 administered in combination with ribavirin for 12 weeks in treatment-naive participants with chronic HCV GT1b.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACH-0143102 plus ribavirin daily | Experimental | ACH-0143102 loading dose (225 milligrams [mg]) on Day 1, followed by maintenance doses (75 mg) on Days 2-84, plus weight-based ribavirin as per label on Days 1-84. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACH-0143102 | Drug |
| ||
| Ribavirin |
| Measure | Description | Time Frame |
|---|---|---|
| Sustained Virologic Response At 12 Weeks (SVR12) | To determine the incidence of the SVR12 after the completion of dosing with ACH-0143102 plus ribavirin, reported as hepatitis C virus ribonucleic acid less than the limit of quantification at that time point. | 12 weeks following the last dose |
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Inclusion Criteria:
Exclusion Criteria:
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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 the baseline day.
Participants were recruited from 6 sites in the United States between 05 September 2012 and 11 December, 2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | ACH-0143102 Plus Ribavirin | ACH-0143102 (225 milligrams [mg]) loading dose on Day 1, followed by maintenance doses (75 mg) on Days 2-84, plus weight-based ribavirin as per label on Days 1-84. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| COMPLETED |
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| NOT COMPLETED |
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The analysis population for baseline characteristics was all enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | ACH-0143102 Plus Ribavirin | ACH-0143102 (225 mg) loading dose on Day 1, followed by maintenance doses (75 mg) on Days 2-84, plus weight-based ribavirin as per label on Days 1-84. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Body Mass Index | Mean | Standard Deviation | kilograms/meter squared |
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| 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 | Sustained Virologic Response At 12 Weeks (SVR12) | To determine the incidence of the SVR12 after the completion of dosing with ACH-0143102 plus ribavirin, reported as hepatitis C virus ribonucleic acid less than the limit of quantification at that time point. | Posted | Number | percentage of participants | 12 weeks following the last dose |
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Adverse event data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up, for up to 36 weeks.
Treatment-emergent adverse events are summarized.
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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 | ACH-0143102 Plus Ribavirin | ACH-0143102 (225 mg) loading dose on Day 1, followed by maintenance doses (75 mg) on Days 2-84, plus weight-based ribavirin as per label on Days 1-84. | 0 | 8 | 6 | 8 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
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| Atrioventricular block second degree | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Eructation | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Haematochezia | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Oral pain | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 16.0 | Systematic Assessment |
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| Influenza like illness | General disorders | MedDRA 16.0 | Systematic Assessment |
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| Irritability | General disorders | MedDRA 16.0 | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA 16.0 | Systematic Assessment |
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| Folliculitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
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| Foreign body in eye | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
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| Muscle strain | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
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| Emotional disorder | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
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| Breast tenderness | Reproductive system and breast disorders | MedDRA 16.0 | Systematic Assessment |
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| Vulvovaginal pruritus | Reproductive system and breast disorders | MedDRA 16.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Upper respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alexion Pharmaceuticals Inc. | Alexion Pharmaceuticals Inc. | 855-752-2356 | clinicaltrials@alexion.com |
| ID | Term |
|---|---|
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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