EUCTR2018-003167-54-ES进行中（未招募）1 期
A Phase 3, Matrix Design, Partially Double-Blind, Randomized Study of the Efficacy and Safety of 50 mg Lonafarnib/100 mg Ritonavir BID with and without 180 mcg PEG IFN-alfa-2a for 48 Weeks Compared with PEG IFN-alfa-2a Monotherapy and Placebo Treatment in Patients Chronically Infected with Hepatitis Delta Virus Being Maintained on Anti-HBV Nucleos(t)ide Therapy (D-LIVR) - D-LIVR
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Chronic HDV infection for at least 6 months in duration, documented by a positive HDV antibody (Ab) test and HDV RNA = 500 IU/mL by quantitative polymerase chain reaction (qPCR) at study entry.
- •Note: Non-genotype 1 HDV will be capped at 15% of total enrollment. Patients with a screening HDV RNA viral load = 4 log10 will make up between 35% and 45% of the total population.
- •2. Demonstrable suppression of HBV DNA (< 20 IU/mL) following at least 12 weeks of anti-HBV nucleos(t)ide treatment with entecavir or tenofovir prior to initiating therapy.
- •3. Serum ALT > 1.3 x upper limit of the normal range (ULN) and < 10 x ULN.
- •4. Willing and able to comply with study procedures and provide written informed consent.
- •5. Need to be able to read and understand language where the patient is participating in the study.
- •6. Need to be able to self-administer medication orally and via subcutaneous (SC) injection.
- •7. Male and female participants who are 18 years of age or above.
- •8. Body mass index (BMI) of = 18 kg/m2 and weight = 45 kg.
- •9. Liver biopsy within 45 days of Day 1 demonstrating evidence of chronic hepatitis. If no liver biopsy is available, the patient must be willing to consent to and have no contraindication to liver biopsy.
- •10. ECGs demonstrating no acute ischemia or clinically significant (CS) abnormality and a corrected QT interval by Fridericia correction formula (QTcF) < 450 ms.
- •11. Normal dilated retinal examination.
- •12. Sexually active female patients of childbearing potential and sexually active male patients with partners of childbearing potential must agree to use adequate methods of contraception during the study. Females of childbearing potential are all those except women who are surgically sterile, who have medically documented ovarian failure, or who are at least 1 year postmenopausal.
- •For female patients:
- •Progestogen injection (eg, Depo-Provera®) for = 3 months before screening AND a barrier method (use of condom [male partner] or diaphragm with spermicide or cervical cap with spermicide) from screening, or
- •Intrauterine device (IUD) or intrauterine system (IUS) in place = 3 months before screening AND a barrier method (use of condom [male partner] or diaphragm with spermicide or cervical cap with spermicide) from screening, or
- •Surgical sterilization of the partner (vasectomy = 1 month before screening) AND a barrier method (use of condom [male partner] or diaphragm with spermicide or cervical cap with spermicide) from screening, or
- •Double-barrier methods (use of condom [male partner] with either diaphragm with spermicide or cervical cap with spermicide) from screening.
- •For male patients:
- •Surgical sterilization (vasectomy = 1 month before screening) AND a barrier method (use of condom or diaphragm with spermicide or cervical cap with spermicide) from screening, or
- •Consistently and correctly use a condom from screening AND female partner must agree to use a hormonal contraceptive, a nonhormonal nonbarrier method (eg, copper IUD), or a nonhormonal barrier method (eg, diaphragm with spermicide or cervical cap with spermicide).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •1.Participation in a clinical trial with, or use of, any investigational agent within 30 days or 5 half-lives, whichever is longer, before screening
- •2.Previous use of LNF within 12 months before pre-screening/screening or during the study
- •3.Female patients who are pregnant or breastfeeding. Male patients with female sexual partners who are pregnant
- •4.Current or previous history of Child-Pugh Class B/C
- •5.Co-infected with HIV/HCV
- •6.Positive results for HIV/HCV Ab at screening. They are allowed if they have completed a curative antiviral regimen and have documented undetectable HCV RNA for at least 3 months
- •7.Evidence of significant portal hypertension such as hepatic venous pressure gradient (HVPG) = 10 mmHg; current presence or history of esophageal or abdominal varices, variceal bleeding, or splenomegaly >12 cm length on Imaging. When the spleen measures larger than 12cm and the PI believes the subject meets all other non cirrhotic criteria, a discussion with the Medical Monitor (MM) is warranted for inclusion
- •8.Current evidence or history of ascites requiring diuretics or paracentesis, or hepatic encephalopathy
- •9.Any of the abnormal laboratory test results:
- •Platelet count <90,000cells/mm3
- •White blood cell (WBC) count <3,000cells/mm3
- •Absolute neutrophil count (ANC) <1,500cells/mm3
- •Hemoglobin: <11g/dL for women, <12g/dL for men
- •Confirmed creatinine clearance
- •Alpha-fetoprotein =100ng/mL
- •Abnormal TSH or total T4 levels (Patients with well-controlled thyroid function may be enrolled)
- •10.Evidence of another form of viral hepatitis or liver disease
- •11.History of hepatocellular carcinoma
- •12.Patients with:
- •Current eating disorder
- •Evidence of alcohol substance use disorder or excessive intake, defined as:
- •->20g/day for females or
- •->30g/day for males
- •Blood alcohol concentration >0.08%
- •Drug abuse within the previous 6 months, with the exception of cannabinoids and their derivatives
- •13.Prior history or current evidence of:
- •Immunologically mediated disease that requires more than intermittent nonsteroidal anti-inflammatory medications for management or that requires chronic use of systemic corticosteroids in the 6 months (periodic use of oral steroid taper and inhaled asthma medications are allowed)
- •Retinal disorder or clinically relevant ophthalmic disorder
- •Any malignancy within 5 years (Exceptions are malignancies surgically excised with curative intent and/or evidence of being disease free for at least 5 years, or successfully treated in-situ carcinoma of the cervix)
- •Cardiomyopathy or significant ischemic cardiac or cerebrovascular disease
- •Chronic pulmonary disease associated with functional impairment, ratio <0.7
- •Pancreatitis or colitis
- •Severe or uncontrolled psychiatric disorder
- •Bone marrow or solid organ transplantation (For patients who are stable for 1 year post-transplantation and do not require immunosuppressive therapy(ies) enrollment may be considered)
- •14.Other significant medical condition that may require intervention during the study. Patients with any serious condition that would preclude evaluation of response or make it unlikely that the contemplated course of therapy and follow-up could be completed. Patients for whom participation in the study would increase their risk
- •15.Any condition that may impact proper absorption should be discussed
- •16.Any prescription, over-the-counter (OTC) product, or herbal product that is not approved by the MM
- •17.Consumption of grapefruit, Seville oranges, or product that contains these within 14 day
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