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Clinical Efficacy and Genotoxic Effect of Entecavir: the Application in Preventing Father-to-Infant Vertical Transmission of Hepatitis B Virus

Clinical Efficacy and Genotoxic Effect of Entecavir: the Application in Preventing Father-to-Infant Vertical Transmission of Hepatitis B Virus

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OOC-16009151
Enrollment
Unknown
Registered
2016-09-04
Start date
2006-03-10
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Viral hepatitis

Interventions

Observation group:A total of 114 couples, fathers, enticavir0.5mg, q.d., oral
Observation group:mothers, HBVac, mothers were negative for anti-HBs vaccinated with the HBVac (0, 1, 6, recombinant yeast 20, or 40 µg
Control group:A total of 116 couples, they does not do any treatment

Sponsors

Qinhuangdao Third Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. couples who tested negative for serum hepatitis A, C, D, and E viruses, and HIV; 2. without any alcoholic liver disease, drug-induced liver injury, and autoimmune liver disease; 3. normal renal function; 4. Singed informed consent forms by all couples; 5. All fathers had a medical history record of 2 to 25 years; 6. Venous blood from the neonates washarvested.

Exclusion criteria

Exclusion criteria: The researchers think the subjects poor adherence; The subjects has a history of hepatocellular carcinoma (HCC) or has a hint of hepatocellular carcinoma (HCC), such as, images of suspicious nodules and or AFP > 50 ng/mL; it may affect patients'treatment compliance, evaluation, or to the research plan any other serious or activities physical and mental diseases exist; The man in addition to the hepatitis B virus merging other infected with the virus; Spouse has hepatitis B virus infection and other virus infection.

Design outcomes

Primary

MeasureTime frame
Liver function;HBV-M;HBVDNA;The side effects of drugs, and safety;Compliance checks;physical examination;

Countries

China

Contacts

Public ContactLihua Cao

Qinhuangdao Third Hospital

clh2777@163.com+86 13091372777

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026