An Open Label, Uncontrolled, Study to Assess the Response of Peg-Intron in naïve Patients With Chronic Hepatitis B and D Co-infection
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 68
- 主要终点
- Number of Participants With a Biochemical Response
研究概览
简要总结
The objective of this study is to determine the effectiveness of peginterferon alfa-2b 1.5 mcg/kg/week administered for 52 weeks (wk) in previously untreated participants coinfected with hepatitis virus B and D. After 52-week treatment and 52-week follow-up, the virologic, biochemical, and histological response will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
- •Age 18-65 years old.
- •HBsAg positive >6 months.
- •ALT >= 2 ULN >6 months.
- •HDV RNA positive serology.
- •Serum antibody to hepatitis delta antigen of IgG and IgM class.
- •Knodell score HAI >= 6 and F >= 0; positive test for intrahepatic Delta antigen in liver biopsy.
- •Women of childbearing potential (includes women who are less than 1 year postmenopausal and women who become sexually active) must be using an acceptable method of birth control (e.g., hormonal contraceptive, medically prescribed IUD, condom in combination with spermicide) or be surgically sterilized (e.g., hysterectomy or tubal ligation).
- •Participants must be free of any clinically significant disease (other than chronic hepatitis B and D), that would interfere with study evaluations.
- •Participants must understand and be able to adhere to the dosing and visit schedules, and agree to record symptom severity scores, medication times, concomitant medications, and adverse events accurately and consistently in a daily diary.
排除标准
- •Age <18 and >
- •Concomitant HCV and/or HIV infection.
- •Actual liver failure (total serum bilirubin >2.5 x normal, prolonged prothrombin time >3 sec, serum albumin <3 g/dl, history of ascites, variceal bleeding, or hepatic encephalopathy).
- •Toxic or autoimmune hepatitis (ANA titers > 1:160), metabolic liver diseases (Wilson disease, hemochromatosis, α-1 antitrypsin deficiency)
- •Women who are pregnant or nursing.
- •Leukopenia (<2500/mm^3), neutropenia (<1000/mm^3), hemoglobin <10 g/dl, presence of other severe diseases (myocardiopathy, diabetes mellitus, arterial hypertension, neoplasia, neurologic diseases, malnutrition).
- •Antiviral, immunomodulatory, corticosteroid, or chemotherapeutical treatment within 6 months of the participation in the study.
- •Depression and/or psychiatric disorders.
结局指标
主要结局
Number of Participants With a Biochemical Response
时间窗: 52 weeks (EOT), 104 weeks (EOF)
A participant was defined as a responder if his alanine aminotransferase (ALT) level after 52 weeks, i.e. at EOT, was below the upper reference range as specified by Bioclinica. The normal reference range for ALT is 5-55 U/L.
Number of Participants With a Combined Response
时间窗: 52 weeks (EOT), 104 weeks (EOF)
The combined response was defined as an ALT level below the upper reference range and a negative HDV-RNA test. The normal reference range for ALT is 5-55 U/L.
Number of Participants With a Virological Response
时间窗: 52 weeks (end of treatment [EOT]), 104 weeks (end of follow-up [EOF]) following treatment initiation
For virological response, a participant was defined as a responder if his/her serum sample tested negative for Hepatitis D Virus - ribonucleic acid (HDV-RNA) by polymerase chain reaction (PCR) at end of treatment (EOT).
次要结局
- Number of Participants With a Liver Histology Response(Baseline and 52 week (EOT))
- Number of Participants With Hepatitis B Virus (HBV) Replication Response (HBV Response)(52 week (EOT))