TREATMENT OF PATIENTS WITH CHRONIC HEPATITIS B (HCB) USING PEG-INTERFERON ALPHA 2B

Not Applicable

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

• Registration Number: PER-040-01
• Lead Sponsor: SCHERING PLOUGH RESEARCH INSTITUTE,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2001-07-10
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

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

Inclusion Criteria

• Male or adult woman, patients with chronic hepatitis B between 18 and 70 years of age
• Patients not previously treated for chronic hepatitis B or patients who previously failed treatment with interferon alfa.
• The patient must have documentation of positive serum HBsAg for a minimum of 6 months prior to entering the study.
• The patient must show evidence of HBV replication documented by:
o serum-positive HBV DNA within 3 months prior to entry
o positive serum HBeAg within 3 months prior to entry.
o elevated alanine aminotransferase (TGP) above the upper limit of normal, within 6 months prior to entry
o Compensated liver disease
• Fasting glucose should be 70-115 mg / dl. Results between 115-140 mg / dl require repeating the fasting glucose test to be <140 mg / dl and Hb A1c (glycosylated hemoglobin) <8.5%. The hemoglobin Ale should be <8.5% for diabetic patients (even when in control with diet or medication).
• Thyroid Stimulating Hormone (TSH), within normal limits (patients requiring medication to maintain TSH levels in the normal range are eligible if they meet all other inclusion / exclusion criteria.).
• Antinuclear Antibodies (ANA) <1: 160
• Value of alpha-fetoproteins within the normal limits obtained within a period of one year prior to entry into the study. Results above the upper limit of normal but <50 mg / ml
• Negative Hepatitis C serum antigen
• HIV negative (Positive ELISA results will be confirmed by Western Blot)
• If there is a history of diabetes or hypertension, an eye examination is required.
• Written informed consent
• Reconfirmation that sexually active women with the possibility of getting pregnant are using some appropriate contraceptive method (intra uterine device, diaphragm ± spermicide or condom ± spermicide, oral contraceptives, progesterone implants (Norplant), medroxyprogesterone acetate (Depo-Provera), sterilization surgical, or monogamous relationship with a male partner who has had a vasectomy) during the period of treatment. Women patients should not be breastfeeding.
• Reconfirmation that sexually active men are using acceptable methods of contraception (vasectomy, condom ± spermicide, monogamous relationship with a woman partner who practices an acceptable method of contraception during the period of treatment.

Exclusion Criteria

• Patients over 70 years of age
• Women who are pregnant or breastfeeding
• Suspected hypersensitivity to interferon or PEG-interferon.
• Participation in any other clinical trial within 30 days prior to entering this study.
• Treatment with any investigational drug within 30 days prior to entry into this study.
• Patients with organ transplants other than cornea and hair transplant.
• Any cause of liver disease based on the patient´s history and biopsy (where applicable) other than chronic hepatitis B
• Known positivity of HTV
• Evidence of advanced liver disease such as history or presence of ascites, bleeding varices, spontaneous encephalopathy
• Any known pre-existing medical condition that could interfere with the patient´s participation and its completion in the study
• Any medical condition that requires, or will likely require, during the course of the study, a chronic, systematic administration of steroids.
• Clinical Drop
• Substance abuse, such as alcohol (> 80 g / day), LV drugs. or drugs that are inhaled. If the patient has a history of substance abuse, to be considered for inclusion in the study, the patient must have abstained from using the substance of abuse for at least 2 years. Patients who received methadone within the last 2 years are also excluded.
• Patients with significant abnormalities in the retina.
• Patients who do not wish to be advised or who do not wish to abstain from alcohol consumption.
• Any other condition that in the opinion of the investigator would make the patient unfit for inclusion, or that could interfere with the patient´s participation to complete the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Loss of markers in the serum of hepatitis B virus replication (both HBeAg and HBV DNA)<br>Measure:Markers in the serum of hepatitis B virus replication<br>Timepoints:32 weeks<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:Serum tests of HBsAg and serum transaminases<br>Measure:Effect of therapy on HBsAg and serum transaminases<br>Timepoints:32 weeks<br>;<br>Outcome name:Complete Response: TGP figures within normal limits and / or negative HBV-DNA.<br>Measure:Response to combined treatment<br>Timepoints:It will be determined at the end of the 32 weeks of treatment and 6 months after finishing the treatment.<br>;<br>Outcome name:Any serious adverse event, whether or not expected or related to the drug, should be reported by the attending physician.<br>Measure:Adverse events<br>Timepoints:When the adverse event appears<br>