EUCTR2007-000178-21-SK进行中（未招募）1 期
An Open-Label Clinical Study Evaluating the Long-Term Safety of ALTU-135 for the Treatment of Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
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
- •= 7 years of age
- •2. Females of childbearing potential must be willing to use birth control (IUD; oral,
- •transdermal or parenteral contraceptives; abstinence)
- •3. Diagnosis of CF based upon the following criteria:
- •a. two clinical features consistent with CF; and either
- •? A genotype with two identifiable mutations consistent with CF, or
- •? Sweat chloride > 60 mEq/l by quantitative pilocarpine iontophoresis
- •4. Clinically stable with no evidence of acute upper or lower respiratory tract infection
- •5. PI determined by fecal elastase < 100 µg/g measured at the Screening Visit unless
- •previously documented
- •6. Able to take pancreatic enzyme supplementation in the form of capsules
- •7. Able to perform the testing and procedures required for this study, as judged by the Investigator
- •8. Willing and able to provide informed consent or assent
- •Are the trial subjects under 18? yes
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. < 7 years of age
- •2. Pregnancy, breastfeeding or of childbearing potential and not willing to use birth control (IUD; oral, transdermal or parenteral contraceptives; abstinence) during the study
- •3. Participation in an investigational study of a drug, biologic, or device not currently
- •approved for marketing within 30 days prior to the Screening Visit except for the
- •Phase III Efficacy Study (Protocol 0000726)
- •4. History of fibrosing colonopathy
- •5. History of liver transplant, lung transplant or significant surgical resection of the bowel
- •Note: Significant resection of the bowel is defined as any resection of the terminal ileum, or ileo-cecal valve. Patients who have had qualitative, long-term changes in nutritional status after any other bowel resection (e.g., increased, or new, need for supplementation compared to pre-op in order to maintain the same nutritional status) should also be excluded
- •6. Any chronic diarrheal illness unrelated to PI (e.g., sprue or inflammatory bowel disease)
- •7. ALT or AST level > 5 x ULN, or total bilirubin level > 1.5x ULN at the Screening Visit
- •or at Baseline (except for patients with Gilbert Syndrome)
- •8. Signs and/or symptoms of liver cirrhosis or portal hypertension (e.g., splenomegaly, ascites, esophageal varices), or documented liver disease unrelated to CF
- •9. Unable to discontinue enteral tube feedings during the study
- •10. Any condition that the Investigator believes would interfere with the intent of this study or would make participation not in the best interest of the patient.
- •11. Baseline CFA = 93% from the Phase III efficacy study (Protocol 0000726)
- •12. Patient is unlikely to complete the study, as determined by the Investigator
研究者
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