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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 sovaprevir, ACH-0143102, and ribavirin (RBV) in genotype-1 (GT-1), treatment-naive, hepatitis C virus (HCV) participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sovaprevir 200 milligrams (mg), ACH-3102 150/50 mg, RBV 1000-1200 mg | Active Comparator | Sovaprevir 200 mg once daily (qd) + ACH-3102 150 mg loading dose on Day 1, followed by 50 mg qd + RBV weight-based 1000-1200 mg qd for 12 weeks. |
|
| Sovaprevir 400 mg, ACH-3102 150/50 mg, RBV 1000 -1200 mg | Active Comparator | Sovaprevir 400 mg qd + ACH-3102 150 mg loading dose on Day 1, followed by 50 mg qd + RBV weight-based 1000-1200 mg qd for 12 weeks. |
|
| Placebo | Placebo Comparator | Placebo for sovaprevir capsule qd + placebo for ACH-3102 150 mg loading dose on Day 1, followed by placebo for 50 mg qd + placebo for weight-based RBV qd for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sovaprevir | Drug | Nonstructural protein 3/4A protease inhibitor. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence Of Sustained Virologic Response 4 Weeks (SVR4) After The Completion Of Treatment | Incidence of SVR4 after the completion of dosing, reported as hepatitis C virus (HCV) ribonucleic acid less than the lower limit of quantification, in participants who received active treatment (sovaprevir and ACH-0143102 in combination with RBV) as compared to those who received placebo. | Four weeks after the completion of treatment |
| Safety And Tolerability Of 12 Weeks Of Sovaprevir And ACH-3102 In Combination With RBV In GT-1 HCV Participants | To determine the safety and tolerability of 12 weeks of sovaprevir/ACH-0143102/RBV treatment in participants with chronic genotype-1 (GT-1) HCV, the following criteria will be used: the number of participants with discontinuations due to adverse events (AEs), treatment-emergent Grade 3/Grade 4 (G3/G4) AEs, treatment-emergent G3/G4 laboratory abnormalities, and clinically significant electrocardiograms (ECGs). | 12 weeks |
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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 baseline day.
Participants were recruited from 7 sites in the United States and 1 site in Canada between 07 May 2013 and 04 April 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sovaprevir 200 mg, ACH-3102 150/50 mg, RBV 1000-1200 mg | Sovaprevir 200 milligrams (mg) once daily (qd) + ACH-3102 150 mg loading dose on Day 1, followed by 50 mg qd + ribavirin (RBV) weight-based 1000-1200mg qd for 12 weeks. |
| FG001 | Sovaprevir 400 mg, ACH-3102 150/50 mg, RBV 1000-1200 mg | Sovaprevir 400 mg qd + ACH-3102 150 mg loading dose on Day 1, followed by 50 mg qd + RBV weight-based 1000-1200 mg qd for 12 weeks. |
| FG002 | Placebo | Placebo for sovaprevir capsule qd + placebo for ACH-3102 150 mg loading dose on Day 1, followed by placebo for 50 mg qd + placebo for weight-based RBV qd for 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The analysis population for baseline characteristics was the safety population, defined as all randomized participants who received at least 1 dose of the study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sovaprevir 200 mg, ACH-3102 150/50 mg, RBV 1000-1200 mg | Sovaprevir 200 mg qd + ACH-3102 150 mg loading dose on Day 1, followed by 50 mg qd + RBV weight-based 1000-1200 mg qd for 12 weeks. |
| BG001 | Sovaprevir 400 mg, ACH-3102 150/50 mg, RBV 1000-1200 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 | Incidence Of Sustained Virologic Response 4 Weeks (SVR4) After The Completion Of Treatment | Incidence of SVR4 after the completion of dosing, reported as hepatitis C virus (HCV) ribonucleic acid less than the lower limit of quantification, in participants who received active treatment (sovaprevir and ACH-0143102 in combination with RBV) as compared to those who received placebo. | The analysis population for SVR4 was the full analysis (FA) set, defined as all randomized participants who received at least 1 dose of the study drug and had at least 1 baseline/post HCV RNA assessment. For this study, the FA set and the safety population were the same. | Posted | Number | Percentage of participants with SVR4 | Four weeks after the completion of treatment |
|
AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Treatment-emergent AEs were 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 | Sovaprevir 200 mg, ACH-3102 150/50 mg, RBV 1000-1200 mg | Sovaprevir 200 mg qd + ACH-3102 150 mg loading dose on Day 1, followed by 50 mg qd + RBV weight-based 1000-1200 mg qd for 12 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-cardiac chest pain | General disorders | MedDRA version 16.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 16.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alexion Pharmaceuticals Inc. | Alexion Pharmaceuticals Inc. | 855-752-2356 | clinicaltrials@alexion.com |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D006526 | Hepatitis C |
| D008107 | Liver Diseases |
| D006505 | Hepatitis |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| C000629482 | odalasvir |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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|
| ACH-3102 | Drug | Nonstructural protein 5A inhibitor. |
|
| Ribavirin | Drug |
|
| Placebo | Drug |
|
Sovaprevir 400 mg qd + ACH-3102 150 mg loading dose on Day 1, followed by 50 mg qd + RBV weight-based 1000-1200 mg qd for 12 weeks. |
| BG002 | Placebo | Placebo for sovaprevir capsule qd + placebo for ACH-3102 150 mg loading dose on Day 1 followed, by placebo for 50 mg qd + placebo for weight-based RBV qd for 12 weeks. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | Kilograms |
|
| Height | Mean | Standard Deviation | Centimeters |
|
| OG001 | Sovaprevir 400 mg, ACH-3102 150/50 mg, RBV 1000-1200 mg | Sovaprevir 400 mg qd + ACH-3102 150 mg loading dose on Day 1, followed by 50 mg qd + RBV weight-based 1000-1200 mg qd for 12 weeks. |
| OG002 | Placebo | Placebo for sovaprevir capsule qd + placebo for ACH-3102 150 mg loading dose on Day 1, followed by placebo for 50 mg qd + placebo for weight-based RBV qd for 12 weeks. |
|
|
|
| Primary | Safety And Tolerability Of 12 Weeks Of Sovaprevir And ACH-3102 In Combination With RBV In GT-1 HCV Participants | To determine the safety and tolerability of 12 weeks of sovaprevir/ACH-0143102/RBV treatment in participants with chronic genotype-1 (GT-1) HCV, the following criteria will be used: the number of participants with discontinuations due to adverse events (AEs), treatment-emergent Grade 3/Grade 4 (G3/G4) AEs, treatment-emergent G3/G4 laboratory abnormalities, and clinically significant electrocardiograms (ECGs). | The analysis population for safety and tolerability was the safety population, defined as all randomized participants who received at least 1 dose of study drug. For this study, the safety population and the FA set were the same. | Posted | Number | participants | 12 weeks |
|
|
|
| 0 |
| 10 |
| 10 |
| 10 |
| EG001 | Sovaprevir 400 mg, ACH-3102 150/50 mg, RBV 1000-1200 mg | Sovaprevir 400 mg qd + ACH-3102 150 mg loading dose on Day 1, followed by 50 mg qd + RBV weight-based 1000-1200 mg qd for 12 weeks. | 1 | 10 | 10 | 10 |
| EG002 | Placebo | Placebo for sovaprevir capsule qd + placebo for ACH-3102 150 mg loading dose on Day 1, followed by placebo for 50 mg qd + placebo for weight-based RBV qd for 12 weeks. | 0 | 10 | 10 | 10 |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA version 16.1 | Systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA version 16.1 | Systematic Assessment |
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| Tinnitus | Ear and labyrinth disorders | MedDRA version 16.1 | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA version 16.1 | Systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA version 16.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA version 16.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA version 16.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA version 16.1 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA version 16.1 | Systematic Assessment |
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| Haemorrhoids | Gastrointestinal disorders | MedDRA version 16.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA version 16.1 | Systematic Assessment |
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| Odynophagia | Gastrointestinal disorders | MedDRA version 16.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA version 16.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA version 16.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA version 16.1 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA version 16.1 | Systematic Assessment |
|
| Irritability | General disorders | MedDRA version 16.1 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA version 16.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA version 16.1 | Systematic Assessment |
|
| Temperature intolerance | General disorders | MedDRA version 16.1 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA version 16.1 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA version 16.1 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA version 16.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA version 16.1 | Systematic Assessment |
|
| Tinea cruris | Infections and infestations | MedDRA version 16.1 | Systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA version 16.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA version 16.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA version 16.1 | Systematic Assessment |
|
| Vulvovaginal candidiasis | Infections and infestations | MedDRA version 16.1 | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA version 16.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA version 16.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 16.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 16.1 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA version 16.1 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA version 16.1 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA version 16.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 16.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 16.1 | Systematic Assessment |
|
| Disturbance in attention | Nervous system disorders | MedDRA version 16.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA version 16.1 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA version 16.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA version 16.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA version 16.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA version 16.1 | Systematic Assessment |
|
| Micturition urgency | Renal and urinary disorders | MedDRA version 16.1 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA version 16.1 | Systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA version 16.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 16.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 16.1 | Systematic Assessment |
|
| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA version 16.1 | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA version 16.1 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA version 16.1 | Systematic Assessment |
|
| Macule | Skin and subcutaneous tissue disorders | MedDRA version 16.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 16.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA version 16.1 | Systematic Assessment |
|
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA version 16.1 | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA version 16.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA version 16.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA version 16.1 | Systematic Assessment |
|
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.
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
|
| Treatment Emergent G3/G4 Abnormalities |
|
| Clinically Significant ECGs |
|