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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002417-19 | EudraCT Number |
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This is an open-label, single-arm study of sofosbuvir (GS-7977) and ribavirin (RBV) in adults who have had a liver transplant which has become re-infected with hepatitis C. The treatment period is 24 weeks with up to 48 weeks of follow up. The total time in this study will last up to 72 weeks not including the screening visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SOF+RBV | Experimental | Participants will receive sofosbuvir+RBV for 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sofosbuvir | Drug | Sofosbuvir 400 mg tablet administered orally once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) | SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, < 25 IU/mL) 12 weeks following the last dose of study drug. | Posttreatment Week 12 |
| Percentage of Participants Who Discontinue Study Drug Due to an Adverse Event | Baseline to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response (SVR) at 4, 24, and 48 Weeks After Discontinuation of Therapy (SVR4, SVR24, and SVR48) | SVR4, SVR 24, and SVR 48 were defined as HCV RNA < LLOQ 4, 24, and 48 weeks following the last dose of study drug, respectively. | Posttreatment Weeks 4, 24, and 48 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jill M. Denning, MA | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco | California | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25304641 | Result | Charlton M, Gane E, Manns MP, Brown RS Jr, Curry MP, Kwo PY, Fontana RJ, Gilroy R, Teperman L, Muir AJ, McHutchison JG, Symonds WT, Brainard D, Kirby B, Dvory-Sobol H, Denning J, Arterburn S, Samuel D, Forns X, Terrault NA. Sofosbuvir and ribavirin for treatment of compensated recurrent hepatitis C virus infection after liver transplantation. Gastroenterology. 2015 Jan;148(1):108-17. doi: 10.1053/j.gastro.2014.10.001. Epub 2014 Oct 7. |
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49 participants were screened.
Participants were enrolled at a total of 12 study sites in the United States, Europe, and New Zealand. The first participant was screened on 26 October 2012. The last participant observation occurred on 14 August 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | SOF+RBV | Sofosbuvir (SOF) 400 mg tablet once daily plus ribavirin (RBV) tablets (400 mg daily starting dose, then adjusted to 200-1200 mg daily) for 24 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| RBV | Drug | Ribavirin (RBV) 200-mg tablet(s) administered orally in a divided daily dose starting at 400 mg, subsequently adjusted (range: 200 to 1200 mg in a divided daily dose) based upon a number of factors including hemoglobin value, creatinine clearance, and weight. |
|
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| Percentage of Participants With HCV RNA < LLOQ at Weeks 12 and 24 |
| Weeks 12 and 24 |
| HCV RNA and Change From Baseline at Weeks 2, 4, and 8 | Baseline; Weeks 2, 4, and 8 |
| Percentage of Participants With Virologic Failure | Virologic failure was defined as on-treatment virologic failure or virologic relapse.
| Up to Posttreatment Week 24 |
| Indianapolis |
| Indiana |
| United States |
| Kansas City | Kansas | United States |
| Boston | Massachusetts | United States |
| Ann Arbor | Michigan | United States |
| Rochester | Minnesota | United States |
| New York | New York | 10016 | United States |
| New York | New York | 10032 | United States |
| Villejuif | France |
| Hanover | Lower Saxony | Germany |
| Grafton | Auckland | New Zealand |
| Barcelona | Barcelona | Spain |
| COMPLETED |
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| NOT COMPLETED |
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Safety Analysis Set: participants were enrolled and received at least one dose of study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | SOF+RBV | SOF 400 mg tablet once daily plus RBV tablets (400 mg daily starting dose, then adjusted to 200-1200 mg daily) for 24 weeks |
| 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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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| HCV RNA | Mean | Standard Deviation | log10 IU/mL |
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| HCV RNA Category | Number | participants |
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| Prior HCV Treatment | Number | participants |
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| HCV Genotype | Number | participants |
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| IL28b Status | CC, CT, and TT alleles are different forms of the IL28b gene. | 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 12 Weeks After Discontinuation of Therapy (SVR12) | SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, < 25 IU/mL) 12 weeks following the last dose of study drug. | Full Analysis Set: participants were enrolled and received at least one dose of study medication. | Posted | Number | percentage of participants | Posttreatment Week 12 |
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| Primary | Percentage of Participants Who Discontinue Study Drug Due to an Adverse Event | Safety Analysis Set | Posted | Number | percentage of participants | Baseline to Week 24 |
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| Secondary | Percentage of Participants With Sustained Virologic Response (SVR) at 4, 24, and 48 Weeks After Discontinuation of Therapy (SVR4, SVR24, and SVR48) | SVR4, SVR 24, and SVR 48 were defined as HCV RNA < LLOQ 4, 24, and 48 weeks following the last dose of study drug, respectively. | Full Analysis Set | Posted | Number | percentage of participants | Posttreatment Weeks 4, 24, and 48 |
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| Secondary | Percentage of Participants With HCV RNA < LLOQ at Weeks 12 and 24 | Participants in the Full Analysis Set with available data were analyzed. | Posted | Number | percentage of participants | Weeks 12 and 24 |
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| Secondary | HCV RNA and Change From Baseline at Weeks 2, 4, and 8 | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | log10 IU/mL | Baseline; Weeks 2, 4, and 8 |
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| Secondary | Percentage of Participants With Virologic Failure | Virologic failure was defined as on-treatment virologic failure or virologic relapse.
| Full Analysis Set | Posted | Number | percentage of participants | Up to Posttreatment Week 24 |
|
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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 | SOF 400 mg tablet once daily plus RBV tablets (400 mg daily starting dose, then adjusted to 200-1200 mg daily) for 24 weeks | 6 | 40 | 39 | 40 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ascites | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (17.0) | Systematic Assessment |
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| Jaundice | Hepatobiliary disorders | MedDRA (17.0) | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
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| Compression fracture | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
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| Haemarthrosis | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
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| Confusional state | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
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| Hallucination | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (17.0) | Systematic Assessment |
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| Lymphopenia | Blood and lymphatic system disorders | MedDRA (17.0) | Systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
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| Oral lichen planus | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA (17.0) | Systematic Assessment |
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| Asthenia | General disorders | MedDRA (17.0) | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA (17.0) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (17.0) | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
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| Candida infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
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| Laceration | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA (17.0) | Systematic Assessment |
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| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
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| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
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| Increased appetite | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
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| Irritability | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (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, Inc. | ClinicalTrialDisclosures@gilead.com |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| 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 |
|---|---|
| D000069474 | Sofosbuvir |
| D012254 | Ribavirin |
| 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 |
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
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| Unknown or Not Reported |
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| Asian |
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| Other |
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| Spain |
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| Germany |
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| New Zealand |
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| > 7 log10 IU/mL |
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| Genotype 3A |
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| Genotype 3B |
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| Genotype 4 |
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| TT |
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| Categories |
|---|
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| Denominators |
|---|
| Categories |
|---|
| Week 12 (n = 40) |
| |||||
| Week 24 (n = 38) |
|
| Denominators |
|---|
| Categories |
|---|
| Week 2 (n = 39) |
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| Change from baseline at Week 2 (n = 39) |
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| Week 4 (n = 40) |
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| Change from baseline at Week 4 (n = 40) |
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| Week 8 (n = 40) |
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| Change from baseline at Week 8 (n = 40) |
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