Extension Study SCI-SCV-HCV-P2-001: Long-Term FU in Subj Who Opt for Retreatment With Peg-INF and RBV After Completing Treatment in HCV
An Extension of Study SCI-SCV-HCV-P2-001: Long-Term FU in Subj Who Opt for Retreatment With Pegylated Interferon and Ribavirin After Completing Treatment in a Phase 2 Study and Have Relapsed After at Least 44 Weeks Tx With Peg-IFN and RBV.
Aperçu de l'étude
Description détaillée
In this extension study, subjects will be asked to give permission to share their HCV RNA viral load test results, obtained from local laboratories, at the different time points and will also be asked to give permission to share their SOC dosing information (peg-IFN and RBV). As no SCV-07 treatment, procedures, or assessments will be required during this extension study, no related safety information will be collected.
The study will last up to 72 weeks after subjects complete treatment on study SCI-SCV-HCV-P2-001 and begin retreatment with peg-IFN and RBV.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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California
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Anaheim, California, États-Unis, 92803
- AGMG Clinical Research
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Kentucky
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Louisville, Kentucky, États-Unis
- Univ of Louisville Med/Dental Complex
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Ohio
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Cincinnati, Ohio, États-Unis, 45267
- University of Cincinnati Medical Center
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Washington
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Washington, Washington, États-Unis, 20307
- Walter Reed Army Medical Center
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Subjects who satisfy all of the following criteria may be enrolled into the study:
Subjects must be able to understand and sign an ICF approved by the investigator's institutional review board (IRB) for this study; must have completed treatment on study SCI-SCV-HCV-P2-001; and must, in the judgment of the investigators, be able to benefit from retreatment per current SOC (peg-IFN and RBV).
Exclusion Criteria:
- Subjects who satisfy any of the following criteria will not be enrolled into the study:
Subjects who, in the opinion of the investigators, will be unable to tolerate retreatment with peg-IFN and RBV for at least 48 weeks and are at high risk of early treatment discontinuation and plan to participate in another investigational trial prior to providing a final sample for this trial.
Plan d'étude
Comment l'étude est-elle conçue ?
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
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Hepatitis C treatment
This is an extension of ongoing study SCI-SCV-HCV-P2-001.
Subjects will be invited to participate in this extension study if they complete treatment in study SCI-SCV-HCV-P2-001 and are eligible for retreatment with peg-IFN and RBV
|
This is an extension of ongoing study SCI-SCV-HCV-P2-001.
Subjects will be invited to participate in this extension study if they complete treatment in study SCI-SCV-HCV-P2-001 and are eligible for retreatment with peg-IFN and RBV
|
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non cirrhotic subjects
This is an extension of ongoing study SCI-SCV-HCV-P2-001.
Subjects will be invited to participate in this extension study if they complete treatment in study SCI-SCV-HCV-P2-001 and are eligible for retreatment with peg-IFN and RBV
|
This is an extension of ongoing study SCI-SCV-HCV-P2-001.
Subjects will be invited to participate in this extension study if they complete treatment in study SCI-SCV-HCV-P2-001 and are eligible for retreatment with peg-IFN and RBV
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Katharina Modelska, MD, SciClone Pharmaceuticals
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- SCI-SCV-HCV-P2-001-Extension
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