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Long Term Follow-up Registry of Individuals Treated in A Gilead-Sponsored Trial in Individuals With Chronic Hepatitis B Infection

29 septembre 2017 mis à jour par: Gilead Sciences

A Long Term Follow-up Registry of Subjects Treated in A Gilead-Sponsored Trial in Subjects With Chronic Hepatitis B Infection

This study will evaluate the long term effects of hepatitis B virus (HBV) treatment on the HBV serologic changes and HBV DNA levels through Week 144. This registry will enroll only individuals who were treated in a Gilead-sponsored trial for chronic hepatitis B (CHB).

Aperçu de l'étude

Statut

Résilié

Les conditions

Hépatite B chronique

Intervention / Traitement

Type d'étude

Observationnel

Inscription (Réel)

241

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

Australie
- New South Wales
  - Camperdown, New South Wales, Australie
    - Royal Prince Alfred Hospital
Canada
- Alberta
  - Calgary, Alberta, Canada
    - University of Calgary
- British Columbia
  - Vancouver, British Columbia, Canada
    - Gordon and Leslie Diamond Health Care Centre
  - Vancouver, British Columbia, Canada
    - Liver and Intestinal Research Centre
- Manitoba
  - Winnepeg, Manitoba, Canada
    - University of Manitoba
- Ontario
  - Toronto, Ontario, Canada
    - Toronto General Hospital
Corée, République de
- - Busan, Corée, République de
    - Pusan National
  - Seoul, Corée, République de
    - Samsung Medical Center
  - Seoul, Corée, République de
    - Yonsei University
  - Seoul, Corée, République de
    - Seoul National University Bundang Hospital
  - Seoul, Corée, République de
    - Korea University
Hong Kong
- - Lai Chi Kok, Hong Kong
    - Princess Margaret Hospital
  - Sha Tin, Hong Kong
    - Prince of Wales Hospital
Inde
- Gurarat
  - Surat, Gurarat, Inde
    - Nirmal Hospital Private Limited
- Maharashtra
  - Nagpur, Maharashtra, Inde
    - Midas Multispecialty Hospital Private Limited
- West Bengal
  - Kolkata, West Bengal, Inde
    - Dept. of Hepatology, School of Digestive & Liver Diseases
Italie
- - Milano, Italie
    - Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
  - Parma, Italie
    - Azienda Ospedaliera Universitaria di Parma
- Foggia
  - San Giovanni Rotondo, Foggia, Italie
    - IRCCS Ospedale Casa Sollievo della Sofferenza
- Pisa
  - Caianello, Pisa, Italie
    - Azienda Ospedaliera Universitaria Pisana
Nouvelle-Zélande
- - Auckland, Nouvelle-Zélande
    - Auckland City Hospital
États-Unis
- California
  - Sacramento, California, États-Unis
    - Kaiser Permanente
  - San Diego, California, États-Unis
    - Kaiser Permanente
  - San Francisco, California, États-Unis
    - Kaiser Permanente
  - San Jose, California, États-Unis
    - Silicon Valley Research Institute
- Florida
  - Miami, Florida, États-Unis
    - University of Miami
- Hawaii
  - Honolulu, Hawaii, États-Unis
    - The Queen's Medical Center
- Illinois
  - Chicago, Illinois, États-Unis
    - Northwestern University
- Maryland
  - Baltimore, Maryland, États-Unis
    - Digestive Disease Associates, PA
- Massachusetts
  - Boston, Massachusetts, États-Unis
    - Tufts Medical Center
- Michigan
  - Ann Arbor, Michigan, États-Unis
    - University of Michigan
  - Detroit, Michigan, États-Unis
    - Henry Ford Hospital
- Missouri
  - Saint Louis, Missouri, États-Unis
    - St. Louis University
- New York
  - Flushing, New York, États-Unis
    - Medical Procare, PLL
  - Manhasset, New York, États-Unis
    - Northwell Health
- Pennsylvania
  - Philadelphia, Pennsylvania, États-Unis
    - Xiaoli Ma, PC
- Virginia
  - Newport News, Virginia, États-Unis
    - Bon Secours St. Mary's Hospital of Richmond

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

Participants who were treated in a Gilead-sponsored trial for hepatitis B virus infection.

La description

Key Inclusion Criteria:

Must have participated in a Gilead-sponsored chronic hepatitis B (CHB) study no more than 120 days prior to Baseline (Day 1), except for participants from previous Gilead-sponsored study number GS-US-174-0149, who will have up to one year from their last visit in that protocol.
Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
Must be willing and able to comply with the visit schedule and study requirements
Must have documented HBV DNA < 2,000 IU/mL at time of screening visit, which shall occur no later than 1 year post last study visit in GS-US-174-0149
Must have documented hepatitis B surface antigen (HBsAg) negative status anytime during participation in GS-US-174-0149 regardless of ongoing HBV treatment

Key Exclusion Criteria:

Patient participating or planning to participate in another clinical study with an investigational agent
History of clinically-significant illness or any other major medical disorder that may interfere with follow-up, assessments or compliance with the protocol
Believed by the Study Investigator to be inappropriate for study participation for any reason not otherwise listed
Received TDF monotherapy either as part of GS-US-174-0149 Arm C (TDF monotherapy arm) or for TDF retreatment, and have taken any HBV antiviral therapy since completion of GS-US-174-0149

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
Proportion of participants with serum hepatitis B surface antigen (HBsAg) decline ≥ 0.5 log10 IU/ml from baseline at Week 48 Délai: Week 48	This endpoint will be measured for participants who are HBsAg positive at baseline.	Week 48
Proportion of participants who remain HBsAg negative at Week 48 Délai: Week 48	This endpoint will be measured for participants who are HBsAg negative at baseline.	Week 48

Mesures de résultats secondaires

Mesure des résultats	Description de la mesure	Délai
Proportion of participants with serum HBsAg decline ≥ 0.5 log10 IU/ml from baseline at Week 144 Délai: Week 144	This endpoint will be measured for participants who are HBsAg positive at baseline.	Week 144
Proportion of participants who achieve HBsAg loss at Weeks 48 and 144 Délai: Weeks 48, 144	This endpoint will be measured for participants who are HBsAg positive at baseline.	Weeks 48, 144
Proportion of participants who remain HBsAg negative at Week 144 Délai: Week 144	This endpoint will be measured for participants who are HBsAg negative at baseline.	Week 144
Proportions of participants with hepatitis B envelope antigen (HBeAg) loss and seroconversion at Week 48 Délai: Week 48	This endpoint will be measured for participants who are HBeAg positive at baseline.	Week 48
Proportions of participants with HBeAg loss and seroconversion at Week 144 Délai: Week 144	This endpoint will be measured for participants who are HBeAg positive at baseline.	Week 144
Proportions of participants who remain HBeAg negative and hepatitis B envelope antibody (HBeAb) positive at Week 48 Délai: Week 48	This endpoint will be measured for HBeAg positive who achieved HBeAg seroconversion during the parental study.	Week 48
Proportions of participants who remain HBeAg negative and HBeAb positive at Week 144 Délai: Week 144	This endpoint will be measured for HBeAg positive who achieved HBeAg seroconversion during the parental study.	Week 144
Proportion of participants with HBV DNA < the lower limit of quantitation (LLOQ) at Weeks 48, 96 and 144 Délai: Weeks 48, 96 and 144	This endpoint will be measured for participants who are on treatment with oral antiviral (OAV) anti-HBV.	Weeks 48, 96 and 144
Change from Baseline in HBV DNA at Weeks 48, 96, and 144 Délai: Baseline; Week 48; Week 96; Week 144		Baseline; Week 48; Week 96; Week 144

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Gilead Sciences

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

9 décembre 2014

Achèvement primaire (Réel)

14 août 2017

Achèvement de l'étude (Réel)

14 août 2017

Dates d'inscription aux études

Première soumission

3 octobre 2014

Première soumission répondant aux critères de contrôle qualité