EUCTR2018-004258-77-GB进行中（未招募）1 期
A Phase 2, Open Label, Multiple Center Study to Evaluate the Safety, Tolerability, and Efficacy of CM-101 Administered for 12 Weeks in Adult Subjects with Primary Sclerosing Cholangitis. - The SPRING Study
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
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
入选标准
- •Subjects must meet all inclusion criteria to be eligible for the study:
- •1. Males and females, Age 18 Years to 75 Years, both inclusive
- •2. Subjects with diagnosis of large duct PSC (intrahepatic and/or extrahepatic), of more than 6 months duration, based on the EASL 2009 cholestatic guidelines definition (cholestatic liver function tests with consistent magnetic resonance cholangiopancreatography (MRCP) or endoscopic retrograde cholangiopancreatography (ERCP) showing sclerosing cholangitis, +/- a liver biopsy consistent with PSC once secondary causes of sclerosing cholangitis have been excluded).
- •Note: Subjects must have cholangiographic changes showing sclerosing cholangitis in order to be eligible for the study.
- •3. Subjects must have a recent (within 12 months of Day 0) imaging surveillance that is interpreted by the investigator as low risk for cholangiocarcinoma. The minimum imaging requirement is a transabdominal ultrasound however other imaging modalities such as CT or MR are also accepted.
- •Note: Subjects that do not have such imaging will have a transabdominal ultrasound done as part of the screening procedures.
- •4. Subjects with serum ALP greater than 1.5 × upper limit of normal (ULN) as determined by the mean of the Screening and Baseline values
- •5. Subjects receiving Ursodeoxycholic acid (UDCA), must have been stable for =3 months prior to, and including, Day 0 and must not have exceeded 20 mg/kg/day during this time.
- •6. For subjects with concomitant IBD:
- •a. Colonoscopy or other appropriate endoscopic procedure within 12-18 months of Day 0 confirming no dysplasia or colorectal cancer
- •b. Subjects with Crohn’s Disease (CD) must be in remission as defined by a Crohn’s Disease Activity Index (CDAI) <150
- •c. Subjects with ulcerative colitis (UC) must either be in remission or have mild disease. Remission is defined as a partial Mayo score of =2 with no individual sub-score exceeding 1. Mild disease is defined as a partial Mayo score =3 with no individual sub-score exceeding 1 point.
- •7. Subjects receiving concomitant medications need to be on stable therapy for > 3 months prior to study Day 0
- •8. Female subjects of childbearing potential must have a negative serum/urine pregnancy test prior to starting study treatment. Sexually active women of childbearing potential must agree to use an effective method of contraception from the Screening Visit throughout the study period including the 15 weeks post last dose follow-up period.
- •Effective methods of contraception are considered to be those listed below:
- •Barrier method, i.e., (a) condom (male or female) with spermicide or (b) diaphragm with spermicide; or
- •Intrauterine device; or
- •Vasectomy (partner), or
- •Hormonal (e.g., contraceptive pill, patch, intramuscular implant or injection)
- •Abstinence, if in line with the preferred and usual lifestyle of the subject [where abstinence is defined as refraining from heterosexual intercourse during the trial duration (from first administration of investigational product until the end of the 15 weeks post last dose follow-up period)]
- •9. Male subjects, if not vasectomized, must agree to use barrier contraception (con
排除标准
- •Subjects must not meet any exclusion criteria to be eligible for the study:
- •1.Subjects with presence of documented secondary sclerosing cholangitis on prior clinical investigations.
- •2.Subjects with presence of competing etiology of liver disease including, but not limited to, viral hepatitis, alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis etc.
- •3.Subjects with evidence of autoimmune immunoglobin (Ig) IgG4-associated cholangitis,
- •4.Subjects with small duct cholangitis in the absence of large duct disease.
- •5.Subjects with percutaneous biliary drain or bile duct stent
- •6.Subjects that have undergone prior biliary surgery (laparoscopic or open surgery) other than those who at the time of screening are more than 6 weeks after cholecystectomy without surgical complications
- •7.Subjects with evidence of cirrhosis, as determined by local transient elastography taken within 6 months of study screening.
- •8.History of cirrhosis and/or hepatic impairment (Child-Pugh classes A, B and C) and/or hepatic decompensation including ascites, encephalopathy or variceal bleeding
- •9. Subjects who have undergone or are planned for liver transplantation or current model of end stage liver disease
- •10.Subjects with Aspartate aminotransferase (AST) and alanine aminotransferase (ALT); above the allowed cut-offs,
- •11.Subjects with Total Bilirubin > 2 x ULN
- •12.Subjects with International Normalized Ratio (INR) > 1.3 in the absence of anticoagulants
- •13.Subjects with serum creatinine >1.4 mg/dL (123 µmol/L) and/or platelet count <50 x 109/L
- •14.Subjects with history of cholangiocarcinoma or a high suspicion of cholangiocarcinoma, as indicated by clinical judgment, a functional dominant stricture (Bilirubin <2x ULN) or an elevated Ca 19-9 value (>129 U/mL) at screening.
- •15.Subjects with a prior dominant biliary stricture necessitating biliary intervention should have been stable (Bilirubin <2x ULN) for the previous 6 months without intervention and a low level of clinic suspicion of cholangiocarcinoma.
- •16.Subjects with active malignancy (within 3 years of diagnosis), other than:
- •a)adequately treated nonmetastatic basal cell skin cancer;
- •b)squamous cell skin cancer that has been adequately treated and that has not recurred for at least 1 year prior to first study treatment; and
- •17.history of cervical carcinoma in situ that has been adequately treated and that has not recurred for at least 3 years prior to first study treatment. Subjects that lost > 10% of their body weight during the 6 months prior to screening
- •18.Subjects that consume alcohol greater than 21 units/week for males or 14 units/week for females
- •19.Subjects experiencing cholangitis within last 90 days or ongoing need for prophylactic antibiotics
- •20.Subjects experiencing flare in colitis activity within 90 days of screening requiring intensification of therapy beyond baseline maintenance treatment
- •21.Subjects treated with the following medications =6 months of study Day 0 and throughout the trial: fenofibrate or other fibrates and potentially hepatotoxic medications
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