EUCTR2007-000178-21-IT进行中（未招募）不适用
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. - ND
适应症
试验速览
- 阶段
- 不适用
- 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
- •1. Superior or equal to 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 > or equal to 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
相似试验
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 InsufficiencyCystic Fibrosis-Related Exocrine Pancreatic InsufficiencyMedDRA version: 9.1Level: LLTClassification code 10011765Term: Cystic fibrosis pancreasEUCTR2007-000178-21-SKAltus Pharmaceuticals Inc.200
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 InsufficiencyCystic Fibrosis-Related Exocrine Pancreatic InsufficiencyMedDRA version: 9.1Level: LLTClassification code 10011765Term: Cystic fibrosis pancreasEUCTR2007-000178-21-PLAltus Pharmaceuticals Inc.200
进行中（未招募）
1 期
To evaluate the long-term efficacy and tolerability of treatment with dimethyl fumarate in adults with chronic plaque psoriasis.chronic plaque psoriasisMedDRA version: 20.0Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 100000004858EUCTR2017-003818-11-ITALMIRALL SPA300
招募中
3 期
A Clinical Trial to Evaluate the Long-term Safety and Tolerability of SEP-363856 in Patients with Schizophrenia in JapaSchizophreniaJPRN-jRCT2031220039Yabuuchi Kazuki220
进行中（未招募）
1 期
A CLINICAL STUDY TO EVALUATE THE LONG-TERM DERMAL SAFETY PROFILE OF 12-WEEKS TOPICAL ADMINISTRATION OF N-ACETYL-GED-0507-34-LEVO GEL 5% IN PATIENTS WITH FACIAL ACNEFACIAL ACNEMedDRA version: 20.0Level: LLTClassification code 10000519Term: Acne vulgarisSystem Organ Class: 100000004858EUCTR2017-003796-58-ITPPM SERVICES S.A.25