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| Name | Class |
|---|---|
| Vertex Pharmaceuticals Incorporated | INDUSTRY |
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This is an open-label, multi center study of treatment-naive non-cirrhotic subjects with genotype 1 chronic Hepatitis C Virus. All subjects will receive telaprevir (TVR) in combination with sofosbuvir (SOF) for 12 weeks.
Starting on Day 1 and for up to 12 weeks, you will receive Telaprevir (TVR) and Sofosbuvir (SOF).
You will take one (1) 400 mg tablet of SOF and 3 tablets (1125 mg each) of TVR. You should take these together by mouth every morning. You will take another 3 tablets (1125 mg each) of TVR by mouth 12 hours after you take your morning dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telaprevir and Sofosbuvir | Experimental | All subjects will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily. Both will be given for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telaprevir and Sofosbuvir | Drug | All subjects will have time to read and discuss IRB approved consent form prior to any study procedures. Following proper consenting, subjects will undergo physical exam including ECG and bloodwork prior to baseline visit. Subjects will return for research visits (vitals, collection of AEs, bloodwork, drug accountability) on Day 3, Weeks 1, 2, 3, 4, 6, 8, 10 and 12 of treatment and 4, 12, and 24 weeks after end of treatment. PK samples will be collected at week 2 and week 10. |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Adverse Events Leading to Discontinuation of Both Telaprevir and Sofosbuvir Among Subjects Treated With Telaprevir and Sofosbuvir | Study drug adherence and adverse events were collected on all enrolled subjects and graded using the DAIDS scale. Any adverse events leading to discontinuation of both Telaprevir and Sofosbuvir were collected and are hereby reported. | 12 weeks-January 3, 2014- April 10, 2014 |
| Safety of Telaprevir and Sofosbuvir When Dosed in Combination for 12 Weeks | The number of subjects who experienced Grade 3 anemia. Complete blood count was collected at baseline, week 2, week 4, week 8, week 12, week 18, and week 24. Incidence of moderate anemia (Grade 3) observed in the study treatment period. | 1/3/2014-4/10/2014 |
| Measure | Description | Time Frame |
|---|---|---|
| Characterize Steady State of Sofosbuvir Active SOF Metabolite, GS-331007 | Sparse Pharmokinetic blood samples were collected at Week 2 and Week 10 (prior to daily dose) in patients treated with Telaprevir and Sofosbuvir. | 1/17/2014-3/26/2014 |
| Proportion of Subjects Who Achieve Undetectable Hepatitis C Virus RNA at 12 Weeks After Completing Study Drug Regimen |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Sustained Virologic Response at 4 Weeks After Completion of Last Dose | Subjects who complete assigned treatment and have undetectable HCV RNA at 12 weeks after the last planned dose of study treatment | 4/22/2014-5/6/2014 |
Inclusion Criteria:
Exclusion Criteria:
Clinically-significant illness Cirrhosis 2. Screening ECG with clinically significant abnormalities
ALT > 10 x the upper limit of normal (ULN)
AST > 10 x ULN
Direct bilirubin > 1.5 x ULN
Platelets < 150,000/μL
HbA1c > 7.5%
Creatinine clearance (CLcr) < 60 mL /min, as calculated by the Cockcroft-Gault equation
Hemoglobin < 11 g/dL for female subjects; < 12 g/dL for male subjects.
Albumin < 3.1 g/dL
INR > 1.5 x ULN unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR 4. Prior exposure to any approved or experimental HCV-specific direct-acting
5. Pregnant or nursing female or male with pregnant female partner.
6. Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson's disease, alfa-1 antitrypsin deficiency, cholangitis).
7. Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).
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| Name | Affiliation | Role |
|---|---|---|
| DAVID R NELSON, MD | University of Florida | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UF Hepatology Research at CTRB | Gainesville | Florida | 32610 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Telaprevir and Sofosbuvir | All subjects will receive Telaprevir 1125 mg capsule twice a day with Sofosbuvir 400 mg capsule once daily for 12 weeks. In addition, sparse PK samples will be collected at week 2 and week 10. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
HCV GENOTYPE 1 -NON-CIRRHOTIC ADULTS
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| ID | Title | Description |
|---|---|---|
| BG000 | Telaprevir and Sofosbuvir | All subjects will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily. Both will be given for 12 weeks. Telaprevir and Sofosbuvir: All subjects will have an ECG performed. Then they will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily. Both will be given for 12 weeks. In addition, PK samples will be collected at week 2 and week 10. |
| 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 | Frequency of Adverse Events Leading to Discontinuation of Both Telaprevir and Sofosbuvir Among Subjects Treated With Telaprevir and Sofosbuvir | Study drug adherence and adverse events were collected on all enrolled subjects and graded using the DAIDS scale. Any adverse events leading to discontinuation of both Telaprevir and Sofosbuvir were collected and are hereby reported. | Non-cirrhotic Hepatitis C Genotype 1 infected subjects, naive to previous Hepatitis C treatment | Posted | Number | participants | 12 weeks-January 3, 2014- April 10, 2014 |
|
24 weeks
AEs collected from all subjects beginning at baseline through 28 days after last dose of study medication were assigned to treatment phase for evaluation.
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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 | Telaprevir and Sofosbuvir | All subjects will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily for 12 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal bloating | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Giuseppe (Joseph) Morelli, MD | UNIVERSITY OF FLORIDA | 352-273-9467 | GIUSEPPE.MORELLI@MEDICINE.UFL.EDU |
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| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C486464 | telaprevir |
| D000069474 | Sofosbuvir |
| ID | Term |
|---|---|
| D014542 | Uridine Monophosphate |
| D014500 | Uracil Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
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|
|
Plasma HCV RNA levels were assessed using the COBAS TaqMan HCV RNA assay test (v2.0; Roche Diagnostics, Indianapolis, IN, USA; LLOQ=25 IU/mL;limit of detection =15 IU/mL) |
| 6/16/2014-7/2/2014 |
| Proportion of Subjects With Viral Relapse | Defined as Subjects who have undetectable HCV RNA at end of treatment, and confirmed detectable HCV RNA between end of treatment and SVR12 planned assessment time point. | 1/3/2014-9/8/2014 |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Characterize Steady State of Sofosbuvir Active SOF Metabolite, GS-331007 | Sparse Pharmokinetic blood samples were collected at Week 2 and Week 10 (prior to daily dose) in patients treated with Telaprevir and Sofosbuvir. | Posted | Geometric Mean | Standard Deviation | ng/mL | 1/17/2014-3/26/2014 |
|
|
|
| Other Pre-specified | Number of Subjects With Sustained Virologic Response at 4 Weeks After Completion of Last Dose | Subjects who complete assigned treatment and have undetectable HCV RNA at 12 weeks after the last planned dose of study treatment | Posted | Number | participants | 4/22/2014-5/6/2014 |
|
|
|
| Secondary | Proportion of Subjects Who Achieve Undetectable Hepatitis C Virus RNA at 12 Weeks After Completing Study Drug Regimen | Plasma HCV RNA levels were assessed using the COBAS TaqMan HCV RNA assay test (v2.0; Roche Diagnostics, Indianapolis, IN, USA; LLOQ=25 IU/mL;limit of detection =15 IU/mL) | Posted | Number | participants | 6/16/2014-7/2/2014 |
|
|
|
| Primary | Safety of Telaprevir and Sofosbuvir When Dosed in Combination for 12 Weeks | The number of subjects who experienced Grade 3 anemia. Complete blood count was collected at baseline, week 2, week 4, week 8, week 12, week 18, and week 24. Incidence of moderate anemia (Grade 3) observed in the study treatment period. | Posted | Number | participants | 1/3/2014-4/10/2014 |
|
|
|
| Secondary | Proportion of Subjects With Viral Relapse | Defined as Subjects who have undetectable HCV RNA at end of treatment, and confirmed detectable HCV RNA between end of treatment and SVR12 planned assessment time point. | Posted | Number | participants | 1/3/2014-9/8/2014 |
|
|
|
| 1 |
| 20 |
| 19 |
| 20 |
| Abdominal cramps | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Anorectal_symptoms | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA | Systematic Assessment |
|
| Chills | General disorders | MedDRA | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Corneal abrasion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA | Systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA | Systematic Assessment |
|
| Head cold | Infections and infestations | MedDRA | Systematic Assessment |
|
| Head pressure | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Hemorrhoids | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Herniated disc | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Hyperactivity | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Increased frequency of bowel movements | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Induration | General disorders | MedDRA | Systematic Assessment |
|
| Irritability | General disorders | MedDRA | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Lightheadedness | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Lip swelling | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Loose stools | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Painful respiration | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Peripheral edema | General disorders | MedDRA | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Regurgitation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Rib pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Tingling | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA | Systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
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| 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 |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |