Calendario›GILD›Sofosbuvir
Sofosbuvir
Sofosbuvir in Combination With Pegylated Interferon and Ribavirin and in Treatment-Naive Hepatitis C-infected Patients
Ensayo de GILEAD SCIENCES, INC. en Hepatitis C Virus (del registro, en inglés).
- Fase
- Fase 2
- Estado
- Completado
- Participantes
- 147
- Centros
- 23
- Fin del objetivo primario
- abr 2011
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en ago 2010.
Qué mide
Percentage of Participants Who Experienced Adverse Events During the Sofosbuvir Treatment Period (Baseline to Week 12 plus 30 days) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroGenotype 1: Participants with genotype 1 hepatitis C (HCV) infection were randomized to receive sofosbuvir (GS-7977; PSI-7977) 200 mg or 400 mg, or matching placebo, plus pegylated interferon alfa 2a (PEG) and ribavirin (RBV) for 12 weeks, followed by PEG+RBV for an up to an additional 36 weeks. Randomization was stratified by IL28B status (CC, CT, TT) and HCV RNA level (\< 800,000 IU/ml or ≥ 800,000 IU/ml) at baseline. Participants were randomized in a 2:2:1 manner; those who achieved an extended rapid virologic response (eRVR) (HCV RNA \< lower limit of detection \[15 IU/mL\] from Weeks 4 through 12) received an additional 12 weeks of PEG+RBV. Subjects not achieving eRVR received an additional 36 weeks of PEG+RBV. Genotype 2 and 3: Participants with genotype 2 or 3 hepatitis C (HCV) received sofosbuvir 400 mg plus PEG+RBV for 12 weeks.
Más ensayos de GILD
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| Tenofovir DF | Fase 3 | En marcha, sin reclutar | ago 2017 (real) |
| Oral Lenacapavir · CAPELLA | Fase 2/3 | En marcha, sin reclutar | oct 2020 (real) |
| Sacituzumab Govitecan-hziy | Fase 2 | En marcha, sin reclutar | ago 2021 (real) |
| Sacituzumab Govitecan-hziy · EVOKE-01 | Fase 3 | En marcha, sin reclutar | nov 2023 (real) |
| ISL | Fase 2 | En marcha, sin reclutar | dic 2023 (real) |
| Oral Lenacapavir · PURPOSE 1 | Fase 3 | En marcha, sin reclutar | may 2024 (real) |
Todos los de GILD, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT01188772), actualizada en abr 2014.