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This study is to evaluate the safety, tolerability, and antiviral activity of sofosbuvir (SOF) with ribavirin (RBV) in Egyptian adults with chronic genotype 4 hepatitis C virus (HCV) infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SOF+RBV 12 Weeks | Experimental | Treatment-naive and treatment-experienced participants will receive SOF+RBV for 12 weeks. |
|
| SOF+RBV 24 Weeks | Experimental | Treatment-naive and treatment-experienced participants will receive SOF+RBV for 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SOF | Drug | Sofosbuvir (SOF) 400 mg tablet administered orally once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12) | SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment. | Posttreatment Week 12 |
| Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s) | The percentage of participants discontinuing any study drug due to an adverse event was summarized. | Up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. | Posttreatment Weeks 4 and 24 |
| Percentage of Participants Experiencing On-treatment Virologic Failure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathryn Kersey, MSc | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles | California | United States |
76 participants were screened.
Participants were enrolled at one study site in the United States. The first participant was screened on 01 October 2012. The last participant observation occurred on 12 February 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | SOF+RBV 12 Wk | Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000-1200 mg daily based on weight) for 12 weeks |
| FG001 | SOF+RBV 24 Wk | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
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| ID | Title | Description |
|---|---|---|
| BG000 | SOF+RBV 12 Wk TN | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive (TN)) |
| BG001 | SOF+RBV 12 Wk TE | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment experienced (TE)) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12) | SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment. | Full Analysis Set: participants with genotype 4 HCV infection who were randomized into the study and received at least 1 dose of study drug | Posted | Number | percentage of participants | Posttreatment Week 12 |
|
Up to 24 weeks plus 30 days
Safety Analysis Set
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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 | SOF+RBV 12 Wk | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal 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 | |
|---|---|---|---|---|
| Clinical Trial Disclosures | Gilead Sciences, Inc. | ClinicalTrialDisclosures@gilead.com |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| D000069474 | Sofosbuvir |
| ID | Term |
|---|---|
| D014542 | Uridine Monophosphate |
| D014500 | Uracil Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
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| RBV | Drug | Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg) |
|
On-treatment virologic failure was defined as:
|
| Up to 24 weeks |
| Percentage of Participants Experiencing Viral Relapse | Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) at end of treatment, but did not achieve an SVR. | Up to Posttreatment Week 24 |
| BG002 | SOF+RBV 24 Wk TN | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive) |
| BG003 | SOF+RBV 24 Wk TE | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced) |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Liver Cirrhosis | Number | participants |
|
| IL28b Status | CC, CT, and TT alleles are different forms of the IL28b gene. | Number | participants |
|
| HCV RNA (log10 IU/mL) | Mean | Standard Deviation | log10 IU/mL |
|
| HCV RNA Category | Number | participants |
|
| OG002 | SOF+RBV 24 Wk TN | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive) |
| OG003 | SOF+RBV 24 Wk TE | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced) |
|
|
| Primary | Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s) | The percentage of participants discontinuing any study drug due to an adverse event was summarized. | Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug | Posted | Number | percentage of participants | Up to 24 weeks |
|
|
|
| Secondary | Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. | Full Analysis Set | Posted | Number | percentage of participants | Posttreatment Weeks 4 and 24 |
|
|
|
| Secondary | Percentage of Participants Experiencing On-treatment Virologic Failure | On-treatment virologic failure was defined as:
| Full Analysis Set | Posted | Number | percentage of participants | Up to 24 weeks |
|
|
|
| Secondary | Percentage of Participants Experiencing Viral Relapse | Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) at end of treatment, but did not achieve an SVR. | Participants in the Full Analysis Set with available data were analyzed. | Posted | Number | percentage of participants | Up to Posttreatment Week 24 |
|
|
|
| 0 |
| 31 |
| 28 |
| 31 |
| EG001 | SOF+RBV 24 Wk | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks | 3 | 29 | 29 | 29 |
| Non-cardiac chest pain | General disorders | MedDRA Version 16.1 | Systematic Assessment |
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| Loss of consciousness | Nervous system disorders | MedDRA Version 16.1 | Systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA Version 16.1 | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA Version 16.1 | Systematic Assessment |
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| Abdominal distension | 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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| Diarrhoea | Gastrointestinal disorders | MedDRA Version 16.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA Version 16.1 | Systematic Assessment |
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| Abdominal pain upper | 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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| Vomiting | Gastrointestinal disorders | MedDRA Version 16.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA Version 16.1 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA Version 16.1 | Systematic Assessment |
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| Fatigue | Gastrointestinal disorders | MedDRA Version 16.1 | Systematic Assessment |
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| Irritability | Gastrointestinal disorders | MedDRA Version 16.1 | Systematic Assessment |
|
| Pain | Gastrointestinal disorders | MedDRA Version 16.1 | Systematic Assessment |
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| Pyrexia | Gastrointestinal disorders | MedDRA Version 16.1 | Systematic Assessment |
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| Malaise | Gastrointestinal disorders | MedDRA Version 16.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA Version 16.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA Version 16.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA Version 16.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 16.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 16.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 16.1 | Systematic Assessment |
|
| Back pain | 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 |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 16.1 | Systematic Assessment |
|
| Flank 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 |
|
| Headache | Nervous system disorders | MedDRA Version 16.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA Version 16.1 | Systematic Assessment |
|
| Memory impairment | Nervous system disorders | MedDRA Version 16.1 | Systematic Assessment |
|
| Disturbance in attention | Nervous system disorders | MedDRA Version 16.1 | Systematic Assessment |
|
| Hypersomnia | Nervous system disorders | MedDRA Version 16.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA Version 16.1 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA Version 16.1 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA Version 16.1 | Systematic Assessment |
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| Pollakiuria | Renal and urinary disorders | MedDRA Version 16.1 | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDRA Version 16.1 | Systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA Version 16.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.1 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.1 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.1 | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.1 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 16.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 16.1 | Systematic Assessment |
|
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA Version 16.1 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA Version 16.1 | Systematic Assessment |
|
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |
| SVR24 |
|