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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 september 2017 uppdaterad av: 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).

Studieöversikt

Status

Avslutad

Betingelser

Kronisk hepatit B

Intervention / Behandling

Studietyp

Observationell

Inskrivning (Faktisk)

241

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Vad mäter studien?

Primära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Proportion of participants with serum hepatitis B surface antigen (HBsAg) decline ≥ 0.5 log10 IU/ml from baseline at Week 48 Tidsram: 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 Tidsram: Week 48	This endpoint will be measured for participants who are HBsAg negative at baseline.	Week 48

Sekundära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Proportion of participants with serum HBsAg decline ≥ 0.5 log10 IU/ml from baseline at Week 144 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: Baseline; Week 48; Week 96; Week 144		Baseline; Week 48; Week 96; Week 144

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Gilead Sciences

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

9 december 2014

Primärt slutförande (Faktisk)

14 augusti 2017

Avslutad studie (Faktisk)

14 augusti 2017

Studieregistreringsdatum

Först inskickad

3 oktober 2014

Först inskickad som uppfyllde QC-kriterierna