跳至主要内容
MedPath Trial logoMedPath TrialMedPath Trial Home
临床试验/NL-OMON51170
NL-OMON51170已完成2 期

A DOUBLE-BLIND, RANDOMIZED, PARALLEL-GROUP, PHASE 2 STUDY TO INVESTIGATE THE EFFECT OF RO7049665 ON THE TIME TO RELAPSE FOLLOWING STEROID TAPERING IN PATIENTS WITH AUTOIMMUNE HEPATITIS - Phase 2 Study for the Effect of RO7049665 in Patients with AIH

Covance0 个研究点目标入组 14 人开始时间: 待定最近更新:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
适应症

试验速览

阶段
2 期
状态
已完成
发起方
Covance
入组人数
14
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 99（—）

入选标准

  • •Inclusion Criteria
  • •Participants are eligible to be included in the study only if all of the
  • •following criteria apply:
  • •Informed Consent
  • •1. Able and willing to provide written informed consent and to comply with the
  • •study protocol according to International Conference on Harmonisation (ICH) and
  • •local regulations.
  • •2. Between 18 to 75 years of age, inclusive, at the time of signing the
  • •informed consent.
  • •Type of Participants and Disease Characteristics
  • •3. Patients with a definite diagnosis of AIH (type 1, 2 and 3) as per
  • •simplified or revised original diagnostic criteria (including response to CCSs)
  • •(Hennes et al 2008).
  • •4. Patients who have been in biochemical remission (complete normalization of
  • •serum transaminases and IgG levels) for * 2 years prior to randomization.
  • •5. Patients who have been on stable treatment (CCSs * NSIs) for at least 6
  • •months prior to randomization.
  • •6. No signs of liver inflammation (HAI * 3) on a liver biopsy taken no more
  • •than 12 months prior to randomization.
  • •7. Patients with AIH who have previously not attempted to taper CCS to 0 mg/day.
  • •8. Body mass index within the range of 18-35 kg/m2 (inclusive).
  • •Sex and Contraception/Barrier Requirements
  • •9. Male and female participants are eligible.
  • •The contraception and abstinence requirements are intended to prevent exposure
  • •of an embryo to the study treatment. Therefore, the reliability of sexual
  • •abstinence for female enrollment eligibility needs to be evaluated in relation
  • •to the duration of the clinical study and the preferred and usual lifestyle of
  • •the participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal,
  • •or post-ovulation methods) and withdrawal are not acceptable methods of
  • •preventing drug exposure.
  • •A female participant is only eligible to participate if she is not pregnant,
  • •not breastfeeding, and at least one of the following conditions applies:
  • •Women of non-childbearing potential (WONCBP),
  • •Women of childbearing potential (WOCBP), who:
  • •Agree to remain abstinent (refrain from heterosexual intercourse) or use at
  • •least one acceptable contraceptive methods during the treatment period and for
  • •at least 28 days after the final dose of study drug.
  • •The following are acceptable contraceptive methods: bilateral tubal occlusion/
  • •ligation, male sexual partner who is sterilized, established proper use of
  • •hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine
  • •devices and copper intrauterine devices, male or female condom with or without
  • •spermicide; and cap, diaphragm, or sponge with spermicide.

排除标准

  • •Exclusion Criteria
  • •Participants are excluded from the study if any of the following criteria apply:
  • •Medical Conditions
  • •1. Patients with cirrhosis (F4 fibrosis by Fibroscan®) with significant
  • •impairment of liver function (Child Pugh category B or C).
  • •2. Any other autoimmune disease (including overlap syndrome) requiring
  • •immunomodulating treatment.
  • •3. History of infection with hepatitis B (hepatitis B surface antigen [HBsAg]
  • •positive and/or anti-HBc positive; HBV vaccinated patients are eligible), human
  • •immunodeficiency virus (HIV; positive HIV antibody test), active hepatitis C
  • •virus (HCV) infection (detectable HCV RNA), detection of replicating CMV or
  • •Epstein-Barr virus.
  • •4. Active infections requiring systemic therapy with antibiotic, antiviral or
  • •antifungal treatment or febrile illness within 7 days before Day *1.
  • •5. History of primary or acquired immunodeficiency.
  • •6. Female patients: Pregnant or lactating.
  • •7. Symptomatic herpes zoster within 3 months prior to screening.
  • •8. History of active or latent tuberculosis or a positive Quantiferon* Gold
  • •9. History of clinically significant severe drug allergies, multiple drug
  • •allergies, allergy to any constituent of the product, or intolerance to topical
  • •10. Lymphoma, leukemia, or any malignancy within the past 5 years, except for
  • •basal cell or squamous epithelial carcinomas of the skin that have been
  • •resected with no evidence of metastatic disease for 3 years and in situ
  • •carcinoma of the cervix that was completely removed surgically. Breast cancer
  • •within the past 10 years.
  • •11. Significant uncontrolled comorbidity, such as cardiac (e.g., moderate to
  • •severe heart failure New York Heart Association [NYHA] Class III/IV),
  • •pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders (excluding
  • •12. Any condition or disease detected during the medical interview/physical
  • •examination that would render the patient unsuitable for the study, place the
  • •patient at undue risk or interfere with the ability of the patient to complete
  • •the study in the opinion of the Investigator.
  • •Prior/Concomitant Therapy
  • •13. CCSs of * 5 mg/day (prednisolone-equivalent dose), or < 2.5 mg CCSs
  • •(prednisolone-equivalent dose) plus immune suppressant, or < 3 mg/day
  • •budesonide with or without immune suppressant.
  • •14. CCSs * 20 mg/day (prednisolone-equivalent dose) or > 9 mg/day budesonide.
  • •15. NSI daily dose higher than recommended standard of care therapy.
  • •16. T or B cell-depleting therapy (e.g., rituximab) within the last 12 months
  • •or T- or B-cell number below normal due to depleting therapy.
  • •Prior/Concurrent Clinical Study Experience
  • •17. Leukocyte apheresis within 12 weeks of screening.
  • •18. Donation of blood or blood products in excess of 500 mL within 3 months
  • •prior to screening.
  • •19. Exposure to any investigational treatment within 6 months prior to Day 1.
  • •Laboratory Abnormalities
  • •20. Abnormal hematologic values:
  • •* Anemia (hemoglobin * 9 g/dL)
  • •* Leukocytosis (white blood cells * 2 * ULN)
  • •* Thrombocytopenia (platelet count * 100,000/*L)
  • 另有 6 项未显示

研究者

发起方
Covance

相似试验

尚未招募
不适用
OT AVAILABLE
PER-050-10Celltrion, Inc.,
已完成
不适用
A RANDOMIZED, DOUBLE BLIND, PARALLEL GROUP, PHASE 1 STUDY TO DEMONSTRATE THE EQUIVALENCE WITH RESPECT TO THE PHARMACOKINETIC PROFILE OF CT-P13 AND REMICADE IN PATIENTS WITH ANKYLOSING SPONDYLITIS.-M45M45
PER-112-10Celltrion, Inc.,
已完成
不适用
A RANDOMIZED, DOUBLE BLIND, PARALLEL GROUP, PHASE 1 STUDY TO DEMONSTRATE THE EQUIVALENCE WITH RESPECT TO THE PHARMACOKINETIC PROFILE OF CT-P13 AND REMICADE IN PATIENTS WITH ANKYLOSING SPONDYLITIS.
PER-052-10Celltrion, Inc.,
进行中（未招募）
1 期
A Study to Investigate the Effect of RO7049665 on the Time to Relapse Following Steroid Tapering in Patients With Autoimmune Hepatitis
EUCTR2020-003990-23-ITF. HOFFMANN - LA ROCHE LTD.84
进行中（未招募）
1 期
A Study to Investigate the Effect of RO7049665 on the Time to Relapse Following Steroid Tapering in Patients With Autoimmune HepatitisAutoimmune Hepatitis (AIH)MedDRA version: 20.1Level: PTClassification code 10003827Term: Autoimmune hepatitisSystem Organ Class: 10019805 - Hepatobiliary disorders
EUCTR2020-003990-23-PTF. Hoffmann-La Roche Ltd84