EUCTR2010-022092-65-BE进行中（未招募）1 期
A phase IIa, randomized, double-blind (subject and investigator blind, sponsor open) placebo-controlled trial to evaluate the safety, tolerability and antiviral activity of oral ACH-0141625 in combination with pegylated interferon alfa-2a and ribavirin in two segments, after 28 days of dosing and, subsequently, after 12 weeks of dosing in subjects with chronic hepatitis C virus genotype 1.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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. Males and females aged 18 years or older
- •2. Chronic HCV infection, documented by one of the following:
- •positive for anti-HCV antibody, HCV RNA, or an HCV genotype at least 6 months before screening, and positive for HCV RNA and anti-HCV antibody at the time of screening;
- •or positive for anit-HCV antibody and HCV RNA at the time of screening with a liver biopsy consistent with chronic HCV infection (or a liver biopsy performed before enrollment with evidence of CHC disease, such as the presence of fibrosis).
- •3. HCV genotype 1 (including 1a, 1b or mixed 1a/1b); subjects with mixed genotypes (e.g. 1/2, 1/3, etc.) or other genotypes (e.g. 2, 3, 4, 5, or 6) will be excluded.
- •4. Females who are post-menopausal and amenorrheic must have an FSH measurement at screening with results in the post-menopausal range for the central laboratory. Females of childbearing potential or surgically sterilized females must have a negative pregnancy test at screening and baseline. Females must use a non-hormonal method of contraception and must agree not to get pregnant during the study and for six months following the discontinuation of standard of care.
- •5. Fertile males, defined as all males physiologically capable of conceiving offspring, may be enrolled in this study. Males in this category must agree to use a condom and his female partner must agree to use one or more methods of contraception from the date of screening until 6 months after their last dose of RBV. Males must not donate sperm while enrolled in this study and for three months following the last exposure to RBV
- •6. Signed and dated written informed consent form
- •7. Willing to participate in all study activities (including the ability to safely self-inject study drug subcutaneously) and all study requirements (including effective contraception) during study period
- •8. Treatment naïve subjects.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Body Mass Index (BMI) > 36
- •2. Pregnant or nursing (lactating) females, confirmed by a positive hCG laboratory test or females contemplating pregnancy. Men whose female partners are pregnant or contemplating pregnancy.
- •3. Participation in any interventional clinical trial within previous 35 days.
- •4. History of participation in a clinical trial with a protease inhibitor or previous treatment with a protease inhibitor, where at least one dose of the protease inhibitor was consumed.
- •5. Use of herbal or homeopathic products, illicit drugs, CYP3A4/5 substrates, inducers or inhibitors (See Appendix 8), hormonal methods of contraception, corticosteroids, immunosuppressives, or cytotoxic agents within 28 days of first dose of study drug.
- •6. History of poor compliance with health and treatment regimens.
- •7. Have a clinically significant laboratory abnormality at screening:
- •Absolute neutrophil count (ANC) <1,500 / mm2 (1.5 x 109/L)
- •Platelets <90,000/mm2 (90 x 109/L)
- •Hemoglobin <13 g/dL for males; <12 g/dL for females
- •Serum creatinine > 1.5 x ULN or creatinine clearance < 50 mL/min; estimated by the Cockroft-Gault formula [(140-age) x weight (kg) / 72 x serum creatinine (mg/dL), if female multiply by 0.85].
- •Total bilirubin > 1.2 mg/dL
- •Segment 1: Serum alanine transaminase (ALT) > 2 x ULN
- •Segment 2: (ALT) > 5 x ULN
- •Segment 1: Serum aspartate aminotransferase (AST) > 2 x ULN
- •Segment 2: (AST) > 5 x ULN
- •Fasting serum glucose > 140 mg/dL and HbA1c > 7.5% (including diabetic subjects on medication) or new onset diabetes.
- •Abnormal thyroid stimulating hormone (TSH) of >1.2 ULN, or unstable thyroid disease.
- •Alpha fetoprotein (AFP) > 20 ng/mL unless a liver imaging study (CT or MRI) shows no clinically significant lesions within 6 months prior to the Baseline visit.
- •8. Known HIV-1 or HIV-2 infection/serology
- •9. Positive Hepatitis B Surface Antigen (HBsAg)
- •10. Segment 1: Subjects with any history of decompensated liver disease defined as cirrhotic subjects with a Child-Pugh score of = 7. Decompensated liver disease includes the presence of ascites, variceal bleeding, hepatic encephalopathy, or other signs of progressive portal hypertension or progressive hepatic insufficiency. (based on fibroscan or liver biopsy). Segment 2: Subjects who have had a liver biopsy that shows bridging fibrosis or cirrhosis (Metavir >3, Ishak>4).
- •11. Nonalcoholic steatohepatitis (NASH) if ballooning degeneration or Mallory bodies are present on liver biopsy.
- •12. Other forms of liver disease (e.g. alcoholic, autoimmune, biliary, Wilson’s, Gilbert’s, Dubin Johnson, and Crigler Najjar syndromes).
- •13. Subjects who prematurely discontinued, interrupted, or dose reduced prior PegIFN-alfa and RBV therapy, due to noncompliance or safety and/or tolerability issues.
- •14. Encephalopathy or altered mental status of any etiology
- •15. History of moderate, severe or uncontrolled psychiatric disease (e.g. depression, including a history of hospitalization or prior suicidal attempt), bipolar disease, schizophrenia, or personality disorder. Subjects with a history of mild, stable depression may be considered provided that a pretreatment assessment (including a depression scale, BDI-II or HADS) of the subject’s affective status supports that the subject is clinically stable. Subjects with a score that is elevated (greater than 29 for BDI-II, 7 for HADS) will require further clinical evaluation for depression prior to inclusion into the study. The in
研究者
相似试验
进行中（未招募）
1 期
A randomized (subjects chosen at random), double-blind (subject andinvestigator blind, sponsor open) placebo-controlled (some subjects will receive placebo) trial to evaluate the safety, tolerability and antiviralactivity of ACH-0141625 taken orally when combined with pegylated interferon alfa-2a and ribavirin, after 28 days dosing and after 12 weeks of dosing in subjects who have chronic hepatitis C.Hepatitis C Virus Genotype 1MedDRA version: 14.0Level: LLTClassification code 10019751Term: Hepatitis C virusSystem Organ Class: 10022891 - InvestigationsMedDRA version: 14.0Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestationsEUCTR2010-022092-65-DEAchillion Pharmaceuticals, Inc.
已完成
不适用
Phase II multi-centre study to evaluate efficacy, safety, and immunogenicity of GMZ2 candidate malaria vaccine in children aged 12 to 60 monthsPaediatricsMalariaPACTR2010060002033537Statens Serum Intitute1,840
进行中（未招募）
不适用
A clinical study to evaluate the efficacy to stop the bleeding and safety of TT-173 applied in the donor site of patients undergoing skin graft.EUCTR2013-002784-25-ESThrombotargets Europe
进行中（未招募）
不适用
A Phase II, Randomized, Controlled, Double-blind, Multi-center, Study to Evaluate Safety and Immunogenicity of Two Doses, Administered Three Weeks Apart, of Two Monovalent H5N1 (Surface Antigen Adjuvanted with MF59C.1) Influenza Vaccines Containing 3.75 mcg or 7.5 mcg of H5N1 Influenza Antigen, in Non-elderly Adult and Elderly Subjects - Dose reductioAvian influenzaEUCTR2009-012385-31-PLovartis Vaccines and Diagnostics S.r.l.770
已完成
2 期
A phase II study of the Cuban adult formulation tetanus and diphtheria vaccine.Tetanustetanus and diphtheriaClostridium InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsCorynebacterium InfectionsActinomycetales InfectionsDiphtheriaRPCEC00000059Finlay Institute225