EUCTR2018-003167-54-IT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
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) assay prior to initiation of study Treatment.
- •Non-genotype 1 HDV will be capped at 15% of total enrollment. Patients with a screening HDV RNA viral load < or = 4 log10 will make up between 35% and 45% of the total population.
- •2. Demonstrable suppression of HBV DNA (< 20 IU/mL) following a minimum 12 weeks of anti-HBV nucleos(t)ide treatment with entecavir or tenofovir (TDF or TAF) prior to initiating study 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. 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:
- •Progestin-based hormonal contraception (implant, injection, oral) associated with inhibition of ovulation for > or = 3 moths before screening. Use of a progestin-based implant or injection method requires the additional use of a barrier method (use of condom [male partner] or diaphragm with spermicide or cervical cap with spermicide) from screening. Use of a progestin-only, oral method requires the additional use of double barrier methods (use of condom [male partner] with either 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).
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
- •and all others exclusion criteris, as stated in the protocol
研究者
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