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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-001478-32 | EudraCT Number |
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To evaluate the effect of ribavirin on second phase plasma hepatitis C virus (HCV) ribonucleic acid (RNA) decline in participants who receive ombitasvir/ABT-450/ritonavir and dasabuvir with full dose ribavirin, low dose ribavirin or without ribavirin for 2 weeks in treatment-naive HCV genotype (GT) 1a-infected adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Ribavirin Full Dose for Last 10 Weeks | Experimental | Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) for 12 weeks and weight-based ribavirin (1000 mg or 1200 mg split BID) for the last 10 weeks. |
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| Arm B: Ribavirin Full Dose for 12 Weeks | Experimental | Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and weight-based ribavirin (1000 mg or 1200 mg split BID) for 12 weeks. |
|
| Arm C: Ribavirin Low-dose for 12 Weeks | Experimental | Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and 600 mg ribavirin once daily for 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ombitasvir/ABT-450/Ritonavir | Drug | Ombitasvir/ABT-450/ritonavir combination tablets |
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| Measure | Description | Time Frame |
|---|---|---|
| Slope of the Second Phase Decline in Plasma HCV Ribonucleic Acid (RNA) Levels During Treatment | HCV viral kinetics in plasma during therapy were modeled through non-linear mixed effect models, including a rapid first phase of initial decline and a slower second phase decline. The slope of the second phase decline was estimated for each treatment arm. | From Week 0 to Week 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emily Dumas, PhD | AbbVie | Study Director |
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Participants were randomized to Arms A or B in a 1:1 ratio first, and once those arms fully enrolled, Arm C was enrolled. Randomization to Arms A and B was stratified by site.
This study was conducted at one clinic in France and one clinic in the United States. Participants were treatment-naïve adults with hepatitis C virus (HCV) genotype (GT)1a infection without cirrhosis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A: Ribavirin Full Dose for Last 10 Weeks | Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) for 12 weeks and weight-based ribavirin (1000 mg or 1200 mg split BID) for the last 10 weeks. |
| FG001 | Arm B: Ribavirin Full Dose for 12 Weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Dasabuvir | Drug | Dasabuvir tablets |
|
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| Ribavirin (RBV) | Drug | Ribavirin tablets |
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Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and weight-based ribavirin (1000 mg or 1200 mg split BID) for 12 weeks. |
| FG002 | Arm C: Ribavirin Low-dose for 12 Weeks | Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and 600 mg ribavirin once daily for 12 weeks. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A: Ribavirin Full Dose for Last 10 Weeks | Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) for 12 weeks and weight-based ribavirin (1000 mg or 1200 mg split BID) for the last 10 weeks. |
| BG001 | Arm B: Ribavirin Full Dose for 12 Weeks | Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and weight-based ribavirin (1000 mg or 1200 mg split BID) for 12 weeks. |
| BG002 | Arm C: Ribavirin Low-dose for 12 Weeks | Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and 600 mg ribavirin once daily for 12 weeks. |
| BG003 | Total | Total of all reporting groups |
| 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, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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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 | Slope of the Second Phase Decline in Plasma HCV Ribonucleic Acid (RNA) Levels During Treatment | HCV viral kinetics in plasma during therapy were modeled through non-linear mixed effect models, including a rapid first phase of initial decline and a slower second phase decline. The slope of the second phase decline was estimated for each treatment arm. | Participants with evaluable HCV RNA to calculate the slope of the second phase. Three participants were excluded due to algorithm non-convergence in the non-linear modeling process. | Posted | Median | Full Range | 1/day | From Week 0 to Week 2 |
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From first dose of study drug until 30 days after last dose; up to 16 weeks.
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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 | Arm A: Ribavirin Full Dose for Last 10 Weeks | Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) for 12 weeks and weight-based ribavirin (1000 mg or 1200 mg split BID) for the last 10 weeks. | 1 | 21 | 17 | 21 | ||
| EG001 | Arm B: Ribavirin Full Dose for 12 Weeks | Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and weight-based ribavirin (1000 mg or 1200 mg split BID) for 12 weeks. | 0 | 19 | 16 | 19 | ||
| EG002 | Arm C: Ribavirin Low-dose for 12 Weeks | Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and 600 mg ribavirin once daily for 12 weeks. | 0 | 6 | 6 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DEPRESSION | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
| |
| DRUG DEPENDENCE | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| INCREASED TENDENCY TO BRUISE | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| LYMPHADENOPATHY | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| PALPITATIONS | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
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| VERTIGO | Ear and labyrinth disorders | MedDRA (19.1) | Systematic Assessment |
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| DRY EYE | Eye disorders | MedDRA (19.1) | Systematic Assessment |
| |
| ABDOMINAL DISCOMFORT | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
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| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
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| CONSTIPATION | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
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| DIARRHOEA | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
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| DRY MOUTH | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
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| DYSPEPSIA | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
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| HAEMATOCHEZIA | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
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| RECTAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
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| ASTHENIA | General disorders | MedDRA (19.1) | Systematic Assessment |
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| FATIGUE | General disorders | MedDRA (19.1) | Systematic Assessment |
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| FEELING ABNORMAL | General disorders | MedDRA (19.1) | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA (19.1) | Systematic Assessment |
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| HYPERBILIRUBINAEMIA | Hepatobiliary disorders | MedDRA (19.1) | Systematic Assessment |
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| HYPERTRANSAMINASAEMIA | Hepatobiliary disorders | MedDRA (19.1) | Systematic Assessment |
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| BRONCHITIS | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
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| FUNGAL SKIN INFECTION | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
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| INFLUENZA | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
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| ORAL CANDIDIASIS | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
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| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
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| URINARY TRACT INFECTION | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
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| LIMB INJURY | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
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| PROCEDURAL HEADACHE | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
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| PROCEDURAL PAIN | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
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| ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED | Investigations | MedDRA (19.1) | Systematic Assessment |
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| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA (19.1) | Systematic Assessment |
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| BODY TEMPERATURE FLUCTUATION | Investigations | MedDRA (19.1) | Systematic Assessment |
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| GLUCOSE URINE PRESENT | Investigations | MedDRA (19.1) | Systematic Assessment |
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| HAEMOGLOBIN DECREASED | Investigations | MedDRA (19.1) | Systematic Assessment |
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| INTERNATIONAL NORMALISED RATIO INCREASED | Investigations | MedDRA (19.1) | Systematic Assessment |
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| PROTHROMBIN LEVEL INCREASED | Investigations | MedDRA (19.1) | Systematic Assessment |
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| DEHYDRATION | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
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| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
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| HYPERMAGNESAEMIA | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
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| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
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| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
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| FLANK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
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| MUSCLE TIGHTNESS | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
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| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
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| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
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| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
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| AMNESIA | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
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| DIZZINESS | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
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| MEMORY IMPAIRMENT | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
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| MIGRAINE | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
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| SYNCOPE | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
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| ANXIETY | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
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| CONFUSIONAL STATE | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
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| DEPRESSED MOOD | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
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| DEPRESSION | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
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| EMOTIONAL DISTRESS | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
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| INSOMNIA | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
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| IRRITABILITY | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
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| MOOD SWINGS | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
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| SLEEP DISORDER | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
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| CHROMATURIA | Renal and urinary disorders | MedDRA (19.1) | Systematic Assessment |
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| DYSURIA | Renal and urinary disorders | MedDRA (19.1) | Systematic Assessment |
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| POLYMENORRHOEA | Reproductive system and breast disorders | MedDRA (19.1) | Systematic Assessment |
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| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
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| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
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| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
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| RESPIRATORY TRACT CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
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| SINUS CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
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| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
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| ANGIOEDEMA | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
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| DERMATITIS CONTACT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
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| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
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| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
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| RASH | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
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| RASH GENERALISED | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
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| FLUSHING | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
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| HYPOTENSION | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
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AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| 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 |
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| ID | Term |
|---|---|
| C588260 | dasabuvir |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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| ≥ 55 - 65 years |
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| ≥ 65 years |
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| Male |
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| Black of African American |
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| Asian |
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| American Indian or Alaskan Native |
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| Native Hawaiian or Other Pacific Islander |
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| Mutli Race |
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| 0.561 |
| Superiority |
This study was an exploratory study to evaluate the effect of ribavirin on the slope of the second phase of HCV RNA decline in participants who received the 3-direct-acting antiviral agent regimen. |