.A.

Not Applicable

• Conditions: -B181 Chronic viral hepatitis B without delta-agent; Chronic viral hepatitis B without delta-agent; B181

• Registration Number: PER-007-97
• Lead Sponsor: ASOCIACION PERUANA JAPONESA DEL PERU,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 1997-11-28
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

•The age must be 18 or more years
•Men and women will be included
•The presence of HBeAg must be certified for at least six months
•Serum alanine aminotransferase (ALT), must be elevated above the normal level, for at least six months, with a value, in the last six months that is greater than double the normal limit.
•The liver biopsy performed within twelve months must affirm the diagnosis of persistent chronic hepatitis or active chronic hepatitis (Biopsies performed before the start of work will not disqualify the patients chosen for the investigation).
•Chronic liver disease should be compensated with a prothrombin time not greater than 5 seconds over the control, serum albumin > 30 g / L (3.0 g / dl), total bilirubin < 68 mmol / L (4 mg / dL).
•The hematocrit > in 30%, the platelet count around 80 per 10 9 / L, the white blood cells around 03 x 109 / L, and the neutrophil polynuclear around 1.5 per 109 / L.
•There must be adequate kidney function and a serum creatinine level of about 180 mmol / L (2.0 mg / dL).
•In case of women who can potentially get pregnant, an adequate method of contraception will be used.

Exclusion Criteria

•Patients who have previously received treatment for chronic active hepatitis with any type of interferon or any type of immunotherapy.
•Treatment for any disease with corticosteroids within the three months preceding the study.
•Any other type of liver disease including hepatitis C, hepatitis delta, alcoholic liver disease, drug-induced liver injury, primary biliary cirrhosis, sclerosing cholangitis, autoimmune hepatitis, hemochromatosis, alpha-1 antitryptin deficiency, or Wilson´s disease (except for cases of hepatitis C and hepatitis delta, clinical criteria will suffice) rule out the co-existence of other liver diseases, not requiring routine laboratory tests). If there were a good number or a representative number of patients with delta hepatitis, it would be convenient to include them in the project.
•Another exclusion criterion will be cases of decompensated cirrhosis based on a history of hepatic encephalopathy, bleeding esophageal varices, or ascites.
•Patients who were HTV-positive by Western Blot are excluded.
•We exclude concomitant cases or with a history of neoplasms except skin cancers or carcinoma of the cervix in situ, cured.
•Patients who are concomitant with chronic hepatitis B have tuberculosis or AIDS are excluded.
•Patients who chronically use any drug that can be excluded are excluded. Hepatotoxic.
•Patients who permanently use aspirin or nonsteroidal anti-inflammatory drugs are excluded.
•Patients who use immunosuppressive drugs are also excluded.
•Patients with rheumatoid arthritis or other autoimmune diseases are excluded.
•Pregnant patients are also included
•Patients who are alcoholic or who use intravenous drugs are excluded within a year prior to the study.
•Patients with non-malignant systemic or high psychiatric or medical risk are also excluded, according to the researcher.
•Patients who have not completed all the conditions indicated in the study protocol prior to treatment with Tα 1 are excluded.
•Patients who may be participating simultaneously in another type of drug study or who participated within 30 days before entering the study are excluded.

Study & Design

• Study Type: Interventional
• Study Design: Not specified