Calendario›GILD›tenofovir DF
tenofovir DF
Treatment of Persistent Viremia (Virus in Blood) in Chronic Hepatitis B Subjects Already Receiving Adefovir Dipivoxil
Ensayo de GILEAD SCIENCES, INC. en Hepatitis B cronica.
Más ensayos de: Hepatitis B crónica.
- Fase
- Fase 2
- Estado
- Completado
- Participantes
- 106
- Centros
- 28
- Fin del objetivo primario
- ene 2008
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, triple ciego. Comenzó en mar 2006.
Qué mide
Percentage of Participants With Plasma HBV DNA < 169 Copies/mL at Week 48 (del registro, en inglés) (48 semanas)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThis study explores the efficacy, safety and tolerability of tenofovir DF (TDF) 300 mg once daily monotherapy versus the combination of emtricitabine 200 mg plus tenofovir DF 300 mg (FTC/TDF) once daily in subjects currently being treated with adefovir dipivoxil (Hepsera) for chronic hepatitis B who have persistent viral replication (detectable hepatitis B virus deoxyribonucleic acid \[HBV DNA\]). Subjects with confirmed (within 4 weeks) plasma HBV DNA ≥ 400 copies/mL during double blind treatment at Week 24 or any time thereafter have the option of receiving 12 weeks of open-label FTC/TDF which may be continued through the end of the 168-week treatment period if there is a virologic response (HBV DNA \< 400 copies/mL). Alternatively, subjects with confirmed HBV DNA \< 400 copies/mL at or any time after Week 24 of double-blind treatment may continue blinded therapy up to Week 168 at the discretion of the investigator. If, in the investigator's opinion, it is felt that continued blinded treatment beyond 24 weeks in subjects with confirmed HBV DNA ≥ 400 copies/mL is not beneficial, the subject may discontinue the study and begin commercially available HBV therapy rather than initiate open-label FTC/TDF.
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 (NCT00307489), actualizada en oct 2011.