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This study is to to evaluate the safety, tolerability, and efficacy of sofosbuvir (SOF) plus ribavirin (RBV) in Egyptian adults with genotype 4 hepatitis C virus (HCV) infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SOF+RBV 12 Weeks | Experimental | Participants will receive SOF+RBV for 12 weeks. |
|
| SOF+RBV 24 Weeks | Experimental | 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 |
| Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event | 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 SVR 24 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 | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Al Mansurah | Egypt | |||||
141 participants were screened.
Participants were enrolled at a total of 3 study sites in Egypt. The first participant was screened on 30 March 2013. The last study visit occurred on 04 August 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | SOF+RBV 12 Weeks | Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000-1200 mg daily based on weight) for 12 weeks |
| FG001 | SOF+RBV 24 Weeks | 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 |
|
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| RBV | Drug | Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) |
|
On-treatment virologic failure was defined as
|
| Up to 24 weeks |
| Percentage of Participants Experiencing Virologic Relapse | Virologic relapse was defined as confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit. | Up to Posttreatment Week 24 |
| Cairo |
| Egypt |
| COMPLETED |
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| NOT COMPLETED |
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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 Weeks, 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 Weeks, TE | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment experienced (TE)) |
| BG002 | SOF+RBV 24 Weeks, 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 Weeks, 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Cirrhosis Status | Number | participants |
| ||||||||||||||||
| IL28b Status | CC, CT, and TT alleles are different forms of the IL28b gene. | Number | participants |
| |||||||||||||||
| HCV RNA | Mean | Standard Deviation | log10 IU/mL |
| |||||||||||||||
| HCV RNA Category | Number | 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 | 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 and received at least one dose of study drug | Posted | Number | percentage of participants | Posttreatment Week 12 |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event | 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 SVR 24 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 Virologic Relapse | Virologic relapse was defined as confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit. | Full Analysis Set | Posted | Number | percentage of participants | Up to Posttreatment Week 24 |
|
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 Weeks | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks | 0 | 52 | 34 | 52 | ||
| EG001 | SOF+RBV 24 Weeks | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks | 2 | 51 | 38 | 51 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerebral Ischaemia | Nervous system disorders | MedDRA Version 17.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 17.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 17.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 17.0 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 17.0 | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA Version 17.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA Version 17.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA Version 17.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA Version 17.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA Version 17.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA Version 17.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA Version 17.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA Version 17.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA Version 17.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA Version 17.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 17.0 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 17.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 17.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA Version 17.0 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA Version 17.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA Version 17.0 | Systematic Assessment |
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| Renal colic | Renal and urinary disorders | MedDRA Version 17.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 17.0 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 17.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 17.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 17.0 | Systematic Assessment |
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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:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosures | Gilead Sciences | ClinicalTrialDisclosures@gilead.com |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D004769 | Enterovirus Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D018178 | Flaviviridae Infections |
| D006505 | Hepatitis |
| D006521 | Hepatitis, Chronic |
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069474 | Sofosbuvir |
| ID | Term |
|---|---|
| D014542 | Uridine Monophosphate |
| D014500 | Uracil Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |
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| Male |
|
| Yes |
|
| CT |
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| TT |
|
| ≥ 800,000 IU/mL |
|
|
|
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SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced)
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