The Curative Effect and Security of Interferon Combined Resveratrol on HBeAg Positive Chronic Hepatitis B Patients

NCT03546530 | Completed

• 1 other identifier: 2014ZX10002002
• Study Type: interventional
• Target: 228
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to use Interferon Combined Resveratrol to treat patients with hepatitis B, which may provide a novel therapy target hepatitis B.

Conditions

Hepatitis B; Interferon

Outcome Measures

Primary Outcomes (1)

• HBeAg seroconversion rate

  HBeAg seroconversion rate

  48week

Study Arms (2)

Interferon

EXPERIMENTAL

Interferon 1.5ug/kg/week, 48weeks

Drug: Interferon

Interferon+resveratrol

EXPERIMENTAL

Interferon 1.5ug/kg/week,resveratrol 1000mg/day, 48weeks

Drug: Interferon+resveratrol

Interventions

Interferon DRUG

Interferon

Interferon

Interferon+resveratrol DRUG

Interferon+resveratrol

Interferon+resveratrol

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Serologic evidence of chronic hepatitis B infection more than 6 months- HBeAg positive and HBeAb negative； HBV DNA≥20000 IU/ml (equals to 105 copy/ml)； 2×ULN ≤ALT≤10×ULN，TBIL\<2×ULN

You may not qualify if:

• Has history of decompensated liver diseases Has been treated with other anti-virus drugs, or anti-tumor drugs, immuno-suppression drugs Has a history of autoimmune hepatitis History of a severe seizure disorder or current anticonvulsant use History or other evidence of a medical condition associated with chronic liver disease other than HBV which would make the patient, in the opinion of the investigator, unsuitable for the study (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures) History of thyroid disease poorly controlled on prescribed medications, elevated thyroid stimulating hormone (TSH) concentrations with elevation of antibodies to thyroid peroxidase and any clinical manifestations of thyroid disease

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

Related Publications (1)

• Wang X, Chi X, Wu R, Xu H, Gao X, Yu L, Liu L, Zhang M, Tan Y, Niu J, Jin Q. Serum HBV RNA correlated with intrahepatic cccDNA more strongly than other HBV markers during peg-interferon treatment. Virol J. 2021 Jan 6;18(1):4. doi: 10.1186/s12985-020-01471-2.

  PMID: 33407619 DERIVED

MeSH Terms

Conditions

Hepatitis B

Interventions

Interferons

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Junqi Niu, PHD

  The First Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2018
• First Posted: June 6, 2018
• Study Start: June 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: October 14, 2020

Record last verified: 2018-05