NCT00753467Unknown2 期
Protocol Title: A Phase II Open-labeled Study to Determine the Safety and Preliminary Efficacy of Interferon-gamma 1b (IFN-γ 1b) in Patients With Chronic Hepatitis B Who Are HBV DNA Positive
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The primary objective is to evaluate the safety and tolerability of IFN-γ 1b either alone or in combination with Adefovir dipivoxil in patients with chronic Hepatitis B.
研究概览
简要总结
Open-label, prospective, two part study evaluating IFN-γ 1b at a dose of 200μg by subcutaneous injection every day either alone or in combination with Adefovir dipivoxil or Adefovir dipivoxil alone at a dose of 10mg QD in patients with chronic Hepatitis B.
详细描述
After signing the informed consent potential patients will undergo a screening medical history, physical examination, and laboratory tests.
The study will consist of two parts:
- Part A: IFN-γ 1b monotherapy
- Part B: IFN-γ 1b combination therapy with Adefovir dipivoxil or Adefovir dipivoxil monotherapy
Patients will be enrolled sequentially into to one of three treatment groups. In Part A, ten patients will be enrolled and will receive IFN-γ 1b 200μg, administered every day by subcutaneous injection for 4 weeks. If HBV DNA is reduced by ≥ 1 log10 copies/ mL in ≥ 30% of patients the protocol will proceed to Part B.
In Part B, twenty patients will be enrolled into two cohorts (total of 10 for each cohort) and treated for four weeks. The two cohorts will be administered:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must fulfill all of the following criteria to be eligible for enrollment into the study:
- •Men or women age 18 to 75 years
- •Chronic hepatitis B infection based on a history of positive anti-HBsAg and positive for HBV DNA and with or without elevations in liver tests (test to be repeated on screening)
排除标准
- •Patients with any of the following will be excluded from randomization:
- •Presence of clinically evident cirrhosis including: ascites requiring active diuretic therapy, history of or therapy for hepatic encephalopathy, or history of GI variceal bleeding
- •Platelet count < 50,000/mm3
- •Serum ALT level > 10 times upper limit of normal
- •Alpha-fetoprotein level ≥ 200 ng/mL or alpha-fetoprotein level between 50-200 ng/mL in association with liver ultrasound or other radiographic abnormality suspicious for hepatic neoplasm
- •Serum creatinine level > 1.6 mg/dL
- •Hematology outside of specified limits: neutrophil count <1000/mm3, hemoglobin <10 g/dL in males and <9 g/dL in females
- •Unstable or uncontrolled thyroid disease
- •Treatment with any interferon-α or nucleoside/tide analog within the previous 4 weeks
- •Presence of clinically significant cryoglobulinemia (e.g., skin rash, arthritis, or renal insufficiency due to cryoglobuliemia)
- •Presence or history of autoimmune hepatitis, alpha-1 anti-trypsin deficiency, hemochromatosis, Wilson's disease, drug- or toxin-induced liver disease, alcohol-related liver disease, primary biliary cirrhosis, or sclerosing cholangitis (mild-to-moderate steatosis is acceptable)
- •Chronic hepatitis C infection
- •Hepatits Delta infection (HDV)
- •Known history of HIV infection or positive HIV antibody test by Western Blot (test performed within 60 days of screening can be used to determine eligibility)
- •A disease known to cause significant alteration in immunologic function including hematological malignancy or autoimmune disorder (e.g. rheumatoid arthritis, systemic lupus erythematosis, autoimmune thyroid disease, leukemia, lymphoma, etc)
- •Concurrent therapy with immunosuppressive drugs or cytotoxic agents such as oral prednisone, cyclosporine, azathioprine, or chemotherapeutic agent(s) (e.g., cyclophosphamide, methotrexate, or cancer chemotherapy) or radiation therapy
- •Behavior that suggests a significant risk of poor compliance including, but not limited to:
- •Illicit drug abuse within the past 3 years
- •Current or history of alcohol abuse within the past 2 years
- •Prior treatment with IFN-γ 1b
- •History of unstable or deteriorating cardiac disease, including but not limited to:
- •Myocardial infarction, coronary artery bypass surgery, or angioplasty within the past 6 months
- •Congestive heart failure requiring hospitalization within the past 6 months
- •Uncontrolled arrhythmias
- •Transient ischemic attacks (TIAs)
- •Any cardiac condition that, in the opinion of the site PI, might be significantly exacerbated by flu-like symptoms associated with the administration of IFN γ 1b
- •Preexisting (within last two years) or active psychiatric condition including severe depression, major psychoses, suicidal ideation or suicidal attempts
- •History of (within last two years) or current neurologic or psychiatric disorder that, in the opinion of the site PI, might be exacerbated by flu-like symptoms associated with the administration of IFN γ 1b. In addition, patients with the following conditions should be excluded:
- •History of multiple sclerosis
- •Seizures within the past 2 years
- •Severe or poorly controlled diabetes
- •Pregnancy or lactation. Females of childbearing potential are required to have a negative urine pregnancy test prior to treatment and must agree to practice abstinence or prevent pregnancy by at least a barrier method of birth control for the duration of the study
- •Hemoglobinopthies (e.g. thalassemia, sickle cell disease)
- •Any serious or chronic disease that, in the opinion of the Principal Investigator (PI), may affect the assessment of safety or efficacy parameters. This includes, but is not limited to, patients with malignancy who are receiving chemotherapy, chronic obstructive pulmonary disease or asthma requiring maintenance oral steroids, or active kidney disease
- •Any condition which, in the opinion of the site PI, is likely to result in the death of the patient within the next year
- •Patients who, in the opinion of the site PI, are not suitable candidates for enrollment or would not comply with the requirements of the study
- •Patients who have had a liver transplant
- •Patients who have Adefovir mutations on baseline tests
研究组 & 干预措施
1
Experimental
IFN-γ 1b monotherapy: 200 micro-grams daily for 30 days
干预措施: IFN-γ 1b (Actimmune) (Drug)
2
Experimental
IFN-γ 1b 200 micro-grams daily) combination therapy with Adefovir dipivoxil (10 mg daily) for 30 days
干预措施: IFN-γ 1b and Adefovir dipivoxil combination (Drug)
3
Active Comparator
Adefovir dipivoxil monotherapy (10 mg QD) 30 days
干预措施: Adefovir dipivoxil (Drug)
结局指标
主要结局
The primary objective is to evaluate the safety and tolerability of IFN-γ 1b either alone or in combination with Adefovir dipivoxil in patients with chronic Hepatitis B.
时间窗: 30 days
次要结局
- Evaluate the changes in serum HBV DNA concentrations following administration of Adefovir dipivoxil alone, IFN-γ 1b either alone or in combination with Adefovir dipivoxil in patients with chronic Hepatitis B.(30 days)
- Evaluate the changes in liver tests and hematology following administration of Adefovir dipivoxil alone, IFN-γ 1b either alone or in combination with Adefovir dipivoxil in patients with chronic Hepatitis B.(30 days)
研究者
研究点 (1)
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