- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01326546
Therapeutic Hepatitis B Vaccine (Mimogen-based) Joint Entecavir in Treating Chronic Hepatitis B Patients
A Randomized, Double-blind, Multicenter Phase II Clinical Trial to Evaluate the Efficacy and Safety of Therapeutic Hepatitis B Vaccine (Mimogen-based) Joint Entecavir in Treating HBeAg Positive Chronic Hepatitis B Patients
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Eligible subjects are enrolled and assigned into 2 groups randomly with a 1:1 ratio:
- Therapeutic HBV vaccine Joint Entecavir group:Inject εPA-44 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48 + Oral intake entecavir 0.5mg per day ;
- Empty liposome Joint Entecavir group:Inject empty liposome at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48 + Oral intake entecavir 0.5mg per day.
The study cycle consists of screening and enrollment period (week -4~0), treatment and follow-up period (week 0-96).
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 2
Kontakte und Standorte
Studienorte
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Beijing, China
- 302 Militray Hosptial of China
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ChongQing, China
- Southwest Hospital
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Anhui
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Hefei, Anhui, China
- The First Affiliated of Anhui Medical University
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Beijing
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Beijing, Beijing, China
- Beijing YouAn Hosptial,Capital Medical University
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Guangdong
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Shenzhen, Guangdong, China
- The Third People's Hosptial of Shenzhen
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Hubei
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WuHan, Hubei, China
- Renmin hosptial of Wuhan University
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Hunan
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ChangSha, Hunan, China
- Xiangya Hospital Central South University
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Changsha, Hunan, China
- The second Xiangya Hospital of Central South University
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Jiangsu
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NanJing, Jiangsu, China
- 81th Hospital of PLA
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NanJing, Jiangsu, China
- Jiangsu Province Hospital
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Nanjing, Jiangsu, China
- The Second Hospital of Nanjing
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Shanxi
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XiAn, Shanxi, China
- Tangdu Hospital
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Yunnan
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Kunming, Yunnan, China
- First Affiliated Hospital of Kunming Medical University
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Zhejiang
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Hangzhou, Zhejiang, China, 310006
- The First Affiliated Hospital of Zhejiang University
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WenZhou, Zhejiang, China
- The First Affiliated Hospital of Wenzhou Medical University
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-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Aged 18-65 years, male or female;
Conforming to diagnosis standard of chronic hepatitis B according to " 2005 Guideline for Prevention and Treatment of Hepatitis B " , (with positive HBsAg for more than 6 months), never have systemic treatment of anti-HBV viral ,and
- HBV-DNA ≥ 1.72×10^4 IU/ml;
- HBeAg (+), HBeAb (-);
- ALT within 2 to 10 times of ULN (upper limits of normal);
- HLA-A2 positive;
Compensatory liver disease having following hematological and biochemical parameters:
- WBC ≥ 3.5×10^9/L;
- ANC ≥ 1.5×10^9/L;
- PLT ≥ 80×10^9/L;
- Hb ≥ 100g/L;
- TBil ≤ 1.5 ULN;
- ALB not lower than low limit of normal value;
- BUN no more than high limit of normal value;
- Cr ≤ 1.5 ULN high limit of normal value;
- PT elongation ≤ 3 sec, APTT in normal value;
- Fasting blood glucose ≤ 7.0mmol/L;
- TSH in normal value;
- AFP test result no more than high limit of normal value;
- Take effective contraception for subject with child-bearing potential (including females and female partners of males);
- Understand and sign ICF approved by EC;
- Willing to comply with the study procedures and complete the study.
Exclusion Criteria:
- Antibodies of HCV, HDV or HIV is positive;
- ANA titer > 1:100;
- Decompensated liver disease (such as gullet and pylorus varicose veins, hepatic encephalopathy);
Have the following illness or with severe disease inappropriate to participate in the study in the view of the investigator, in cardiovascular system: instable or significant cardiovascular illness such as angina pectoris, heart attack of myocardial infarction, congestive heart failure, severe hypertension, significant arrhythmia or abnormal ECG etc;
- Respiratory system: bronchiectasia, bronchial asthma, chronic obstructive pulmonary disease, respiratory failure, etc;
- Endocrine, metabolism diseases: diabetes mellitus, uncontrolled thyroid diseases, etc;
- Others: autoimmune disorder, active tuberculosis, malignancies (e.g.: tumor), neuropathic, metal, acute or chronic pancreatitis illness history, etc.
- Have used anti-HBV drug ( Interferon, Lamivudine, Adefovir Dipivoxil, Entecavir and Telbivudine ) and immunomodulator ( Thymic peptide, etc ) to the administration of study medication;
- Have allergic diathesis or have suspected allergy to εPA-44;
- Female in pregnancy, lactation or those who plan to pregnancy during the course of the study;
- Have history of alcohol abuse (Alcohol consumption for more than 5 years, with daily consumption over 40g for males and over 20g for females) and known drug dependence;
- Have history of organ transplantation (except corneal transplantation and hair transplantation);
- Have participated in any other drug clinical investigations within 3 months;
- Any other factors inappropriate for enroll in the study or study completion in the view of the investigator.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Vervierfachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: Therapeutic HBV vaccine+Entecavir
Inject εPA-44 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48 and Oral intake entecavir 0.5mg per day.
|
Inject εPA-44 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48.
Andere Namen:
0.5mg,per day,oral intake.
Andere Namen:
|
Placebo-Komparator: placebo+Entecavir
Placebo comparator: Inject placebo 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48 and Oral intake entecavir 0.5mg per day.
|
0.5mg,per day,oral intake.
Andere Namen:
Inject placebo 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48.
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Percentage of Participants With HBeAg Seroconversion at Week 48
Zeitfenster: 48 weeks
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Primary endpoint data were summarised under "End of Study",using the last available post-baseline observation(Last Observation Carried Forward,LOCF)
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48 weeks
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Serological Response
Zeitfenster: 96 weeks
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Serological response at every observation time: serological conversion rate of HBeAg, negative conversion rate of HBeAg, and change of HBeAg.
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96 weeks
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Virological Response
Zeitfenster: 96 weeks
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Virological response at every observation time: the proportion of patients with serum HBV DNA level reduction to undetectable level, decreased amount of serum HBV DNA compared with the baseline value, and HBV DNA load decrease 2 log scales or HBV DNA level <1.72×104 IU/ml.
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96 weeks
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Biochemistry Response
Zeitfenster: 96 weeks
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Biochemistry response at every observation time, mean the ALT level reduce to normal.
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96 weeks
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Histological Response
Zeitfenster: 72 weeks
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Histological response at week 72, mean histological score limited reduce 2 (reduced score 2-5), and no fiber deterioration compare with before treatment.
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72 weeks
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Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Hauptermittler: LanJuan Li, Ph.D., Zhejiang University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des Verdauungssystems
- RNA-Virusinfektionen
- Viruserkrankungen
- Infektionen
- Durch Blut übertragene Infektionen
- Übertragbare Krankheiten
- Leberkrankheiten
- Hepatitis, viral, menschlich
- Hepadnaviridae-Infektionen
- DNA-Virusinfektionen
- Enterovirus-Infektionen
- Picornaviridae-Infektionen
- Hepatitis B
- Hepatitis
- Hepatitis A
- Hepatitis B, chronisch
- Hepatitis, chronisch
- Antiinfektiva
- Antivirale Mittel
- Entecavir
Andere Studien-ID-Nummern
- 71006.04
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
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