A Cohort Study on Long-term Clinical Outcomes of Antiviral Therapy in Patients With Chronic Hepatitis B and Cirrhosis
6 mars 2020 uppdaterad av: Yao Xie, Beijing Ditan Hospital
The Observational Cohort Study on Long-term Clinical Outcomes of Antiviral Therapy in Patients With Chronic Hepatitis B and Cirrhosis
This was a retrospective observational cohort study.
The patients with chronic hepatitis B and cirrhosis who were treated with antiviral therapy in the Second Department of Liver Disease, Beijing Ditan Hospital, Capital Medical University from October 2008 to April 2020 were enrolled.
Patients treated with antiviral drugs including interferon and/or nucleoside (acid) analogues lasting more than 6 months were included in the study.
Interferon, nucleoside (acid) analogue monotherapy, combination therapy, sequential therapy, maintenance therapy and drug withdrawal therapy can all be included in the study.
HBV DNA content, HBsAg/anti-HBs, HBeAg/anti-HBe, biochemical indexes, serum AFP and liver imaging (liver ultrasound) were collected before treatment (baseline), during treatment and after treatment.
The virological response and clinical outcome after antiviral treatment for chronic hepatitis B were observed for at least 288 weeks, and the main evaluation indicators were the occurrence or reversal of cirrhosis complications, hepatocellular carcinoma and mortality.
Secondary evaluation index: the influence factors of different clinical outcomes.
To investigate the long-term virological response and clinical outcome of antiviral therapy in patients with chronic hepatitis B and liver cirrhosis and to clarify its influencing factors.
Studieöversikt
Detaljerad beskrivning
This was a retrospective observational cohort study.
The patients with chronic hepatitis B and cirrhosis who were treated with antiviral therapy in the Second Department of Liver Disease, Beijing Ditan Hospital, Capital Medical University from October 2008 to April 2020 were enrolled.
Patients treated with antiviral drugs including interferon and/or nucleoside (acid) analogues lasting more than 6 months were included in the study.
Interferon, nucleoside (acid) analogue monotherapy, combination therapy, sequential therapy, maintenance therapy and drug withdrawal therapy can all be included in the study.
HBV DNA content, HBsAg/anti-HBs, HBeAg/anti-HBe, biochemical indexes, serum AFP and liver imaging (liver ultrasound) were collected before treatment (baseline), during treatment and after treatment.
The virological response and clinical outcome after antiviral treatment for chronic hepatitis B were observed for at least 288 weeks, and the main evaluation indicators were the occurrence or reversal of cirrhosis complications, hepatocellular carcinoma and mortality.
Secondary evaluation index: the influence factors of different clinical outcomes.
To investigate the long-term virological response and clinical outcome of antiviral therapy in patients with chronic hepatitis B and liver cirrhosis and to clarify its influencing factors.
Studietyp
Observationell
Inskrivning (Förväntat)
10000
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
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Beijing
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Beijing, Beijing, Kina, 100015
- Department of Hepatology Division 2, Beijing Ditan Hospital
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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 till 75 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Antiviral therapy for patients with chronic hepatitis B and cirrhosis.
Antiviral therapies included interferon and / or nucleoside (acid) analogs, and patients who were continuously treated for more than 6 months were included in the study.
All patients with chronic hepatitis B and cirrhosis met the diagnostic criteria of China's Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2015).
Beskrivning
Inclusion Criteria:
- Ages 18 to 75;
- Unlimited gender;
- Patients with chronic hepatitis B treated with interferon and / or nucleoside (acid) analogs (NA) antiviral therapy. All patients with chronic hepatitis B met the diagnostic criteria of the Chinese Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2015)
- No hormones and / or immunosuppressants and other hepatoprotective drugs;
- Sign a written informed consent.
Exclusion Criteria:
- Combined with other hepatitis virus (HCV, HDV) infections;
- Immune liver disease;
- HIV infection;
- long-term alcohol and / or other liver damage drugs;
- mental illness;
- Evidence of liver tumor (liver cancer or AFP> 100 ng / ml);
- Decompensated cirrhosis;
- Those who have serious heart, brain, lung, kidney and other system diseases that cannot participate in long-term follow-up;
- There are hormones and / or immunosuppressants and other hepatoprotective drugs.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Kohort
- Tidsperspektiv: Retrospektiv
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
antiviral therapy group
Patients with chronic hepatitis B and cirrhosis were treated with antiviral drugs
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Antiviral therapy for patients with chronic hepatitis B and cirrhosis.
Antiviral therapies included interferon and / or nucleoside (acid) analogs, and patients who were continuously treated for more than 6 months were included in the study.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
The rate of incidence or reversal of cirrhosis comorbidities, liver cancer, and the incidence of death
Tidsram: 288 weeks after antiviral therapy
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The incidence or reversal of cirrhosis comorbidities, the incidence of liver cancer, and the incidence of death
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288 weeks after antiviral therapy
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
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 (Förväntat)
1 april 2020
Primärt slutförande (Förväntat)
1 april 2021
Avslutad studie (Förväntat)
1 april 2021
Studieregistreringsdatum
Först inskickad
5 mars 2020
Först inskickad som uppfyllde QC-kriterierna
6 mars 2020
Första postat (Faktisk)
10 mars 2020
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
10 mars 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
6 mars 2020
Senast verifierad
1 mars 2020
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Matsmältningssystemets sjukdomar
- RNA-virusinfektioner
- Virussjukdomar
- Infektioner
- Blodburna infektioner
- Smittsamma sjukdomar
- Leversjukdomar
- Hepatit, Viral, Human
- Hepadnaviridae-infektioner
- DNA-virusinfektioner
- Enterovirusinfektioner
- Picornaviridae-infektioner
- Hepatit B
- Hepatit
- Hepatit A
- Hepatit B, kronisk
- Hepatit, kronisk
- Anti-infektionsmedel
- Antivirala medel
- Antineoplastiska medel
- Interferoner
Andra studie-ID-nummer
- DTXY024
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Nej
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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