EUCTR2007-000171-41-PL进行中（未招募）1 期
A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Study Evaluating the Efficacy and Safety of ALTU-135 Treatment in 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
- 176
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
- •Each patient must meet the following criteria to be enrolled in this study.
- •1. = 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
- •b. either genotype with two identifiable mutations consistent with CF,
- •c. 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 stool measured at the Screening Visit.
- •6. Able to take pancreatic enzyme supplementation in the form of capsules.
- •7. Able to perform the testing (e.g., stool collections) and inpatient stays required for this
- •study, as judged by the Investigator.
- •8. Willing and able to provide informed consent or assent.
- •9. Baseline CFA = 80%.
- •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
- •Patients who meet any of the following criteria will be excluded from the study.
- •1. < 7 years of age.
- •2. CFA > 80% at Baseline.
- •3. Pregnancy, breastfeeding or of childbearing potential and not willing to use birth control (IUD; oral, transdermal or parenteral contraceptives; abstinence) during the study.
- •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 acute or chronic diarrheal illness unrelated to PI (e.g. infectious gastroenteritis, sprue, lactose intolerance, inflammatory bowel disease).
- •7. Unable to discontinue enteral tube feedings during the study.
- •8. Known hypersensitivity to food additives.
- •9. Inability to consume the PP diets, in the judgment of the Investigator.
- •10. Participation in an investigational study of a drug, biologic, or device not currently
- •approved for marketing within 30 days prior to the Screening Visit.
- •11. ALT or AST level > 5x ULN, or total bilirubin level > 1.5x ULN at the Screening Visit
- •or at Baseline (except for patients with Gilbert Syndrome).
- •12. Signs and/or symptoms of liver cirrhosis or portal hypertension (e.g., splenomegaly, ascites, esophageal varices), or documented liver disease unrelated to CF‡.
- •13. DIOS in the last six months prior to the Screening Visit.
- •14. Unable to discontinue the use of pancreatic enzymes.
- •15. 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.
- •16. Patient is unlikely to complete the study, as determined by the Investigator.
研究者
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