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This study is to evaluate the safety, tolerability, and antiviral efficacy of sofosbuvir (SOF) in combination with peginterferon alfa 2a (PEG) and ribavirin (RBV) administered for 12 weeks in participants with chronic genotype 2 or 3 hepatitis C virus (HCV) infection who have previously failed prior treatment with an interferon-based regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SOF+PEG+RBV | Experimental | Participants will receive SOF+PEG+RBV for 12 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, < 15 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 12 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 |
|---|---|---|
| Rob Hyland | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alamo Medical Research | San Antonio | Texas | 78215 | United States |
Not provided
| Label | URL |
|---|---|
| Medicine Plus | View source |
| Hepatitis | View source |
| Hepatitis A |
Not provided
56 participants were screened; 47 participants were enrolled and treated, and comprise the Safety Analysis Set and the Full Analysis Set.
Participants were enrolled at a single site in the United States. The first participant was screened on 18 February 2013. The last participant observation occurred on 06 December 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | SOF+PEG+RBV | Sofosbuvir (SOF) 400 mg tablet once daily + peginterferon alfa 2a (PEG) 180 μg subcutaneous injection once weekly + weight-based ribavirin (RBV; 1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Analysis Set: participants enrolled and received at least 1 dose of study drug
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| ID | Title | Description |
|---|---|---|
| BG000 | Genotype 2 | SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 hepatitis C virus (HCV) infection. |
| BG001 | Genotype 3 |
| 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, < 15 IU/mL) at 12 weeks after stopping study treatment. | Full Analysis Set: participants with genotype 2 or 3 HCV infection who were enrolled and received at least 1 dose of study drug | Posted | Number | percentage of participants | Posttreatment Week 12 |
|
Up to 12 weeks plus 30 days
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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+PEG+RBV | SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system 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 |
Not provided
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D006505 | Hepatitis |
| D006506 | Hepatitis A |
| D006521 | Hepatitis, Chronic |
| D019698 | Hepatitis C, Chronic |
| 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 |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D002908 | Chronic Disease |
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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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| PEG | Drug | Peginterferon alfa 2a (PEG) 180 μg administered once weekly by subcutaneous injection |
|
| 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 12 weeks |
| Percentage of Participants Experiencing Viral Relapse | Viral relapse was defined as having HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at the end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement. | Up to Posttreatment Week 24 |
| Hepatitis C | View source |
| Drug Information available for: | View source |
| Ribavirin | View source |
| PEGINTERFERON ALFA-2A | View source |
| U.S. FDA Resources | View source |
SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 3 HCV infection. |
| BG002 | 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 |
|
| Response to prior HCV treatment | Number | participants |
|
SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 3 HCV infection. |
|
|
| 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 enrolled and received at least 1 dose of study drug | Posted | Number | percentage of participants | Up to 12 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 12 weeks |
|
|
|
| Secondary | Percentage of Participants Experiencing Viral Relapse | Viral relapse was defined as having HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at the end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement. | Participants in the Full Analysis Set with available data were analyzed. | Posted | Number | percentage of participants | Up to Posttreatment Week 24 |
|
|
|
| 4 |
| 47 |
| 45 |
| 47 |
| Oesophageal varices haemorrhage | Gastrointestinal disorders | MedDRA Version 16.1 | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA Version 16.1 | Systematic Assessment |
|
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA Version 16.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA Version 16.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 16.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 16.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA Version 16.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 16.1 | Systematic Assessment |
|
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA Version 16.1 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA Version 16.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA Version 16.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 16.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA Version 16.1 | Systematic Assessment |
|
| Decreased appetitie | Metabolism and nutrition disorders | MedDRA Version 16.1 | Systematic Assessment |
|
| Myalgia | 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 |
|
| Insomnia | Psychiatric disorders | MedDRA Version 16.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 16.1 | Systematic Assessment |
|
| Pruritis | Skin and subcutaneous tissue disorders | MedDRA Version 16.1 | Systematic Assessment |
|
| Hypertension | Vascular 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:
| 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 |