An Open-Label, Extension Study of Teduglutide in Japanese Subjects With Short Bowel Syndrome Who Completed 24 Weeks of Treatment in SHP633-306 or TED-C14-004
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 5
- 主要终点
- Change From Baseline in Plasma Citrulline Levels
研究概览
简要总结
The purpose of this clinical study is to evaluate the long-term safety and efficacy of teduglutide in Japanese participants with PN/IV (parenteral nutrition/intravenous)-dependent SBS (short bowel syndrome) who completed SHP633-306 or who were in the extension phase of the TED-C14-004 (NCT02340819) study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who meet all of the following criteria will be enrolled in this study:
- •Ability to voluntarily provide written, signed, and informed consent to participate in the study.
- •Completion of the SHP633-306 study or participation in TED-C14-004 (NCT02340819) Stage 3 or Stage
- •Females of childbearing potential must agree to comply with the contraceptive requirements of the protocol.
- •An understanding, ability, and willingness to fully comply with study procedures and restrictions.
排除标准
- •There are no exclusion criteria for this study.
研究组 & 干预措施
Teduglutide 0.05 mg
Participants will receive Teduglutide 0.05 milligram per kilogram (mg/kg) subcutaneous (SC) injection once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm until Teduglutide is commercially available, the participant's participation in this study is discontinued, or the study is discontinued.
干预措施: Teduglutide (Drug)
Teduglutide 0.05 mg
Participants will receive Teduglutide 0.05 milligram per kilogram (mg/kg) subcutaneous (SC) injection once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm until Teduglutide is commercially available, the participant's participation in this study is discontinued, or the study is discontinued.
干预措施: Syringe (Device)
Teduglutide 0.05 mg
Participants will receive Teduglutide 0.05 milligram per kilogram (mg/kg) subcutaneous (SC) injection once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm until Teduglutide is commercially available, the participant's participation in this study is discontinued, or the study is discontinued.
干预措施: Needle (Device)
Teduglutide 0.05 mg
Participants will receive Teduglutide 0.05 milligram per kilogram (mg/kg) subcutaneous (SC) injection once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm until Teduglutide is commercially available, the participant's participation in this study is discontinued, or the study is discontinued.
干预措施: Vial Adapter for Device (Device)
结局指标
主要结局
Change From Baseline in Plasma Citrulline Levels
时间窗: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)
Plasma citrulline was measured as an assessment of enterocyte mass. Plasma samples were analyzed using a validated high-performance liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. Baseline data refer to the baseline of core studies (SHP633-306 \[NCT03663582\] or TED-C14-004 \[NCT02340819\]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study.
Number of Participants With Clinically Significant Change From Baseline in Vital Sign Measurements
时间窗: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)
Baseline data refer to the baseline of core studies (SHP633-306 \[NCT03663582\] or TED-C14-004 \[NCT02340819\]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study.
Change From Baseline in Days Per Week of PS
时间窗: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)
Baseline data refer to the baseline of core studies (SHP633-306 \[NCT03663582\] or TED-C14-004 \[NCT02340819\]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study.
Number of Participants Who Demonstrated at Least 20 Percent (%) Reduction From Baseline in Weekly Parenteral Support (PS) Volume
时间窗: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)
The weekly volume was calculated as (sum of daily volumes in the diary/number of days with values)\*7. Baseline data refer to the baseline of core studies (SHP633-306 \[NCT03663582\] or TED-C14-004 \[NCT02340819\]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study.
Change From Baseline in Weekly PS Volume
时间窗: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)
The weekly volume was calculated as (sum of daily volumes in the diary/number of days with values)\*7. Baseline data refer to the baseline of core studies (SHP633-306 \[NCT03663582\] or TED-C14-004 \[NCT02340819\]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study.
Percent Change From Baseline in Weekly PS Volume
时间窗: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)
The weekly volume was calculated as (sum of daily volumes in the diary/number of days with values)\*7. Baseline data refer to the baseline of core studies (SHP633-306 \[NCT03663582\] or TED-C14-004 \[NCT02340819\]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study.
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Values
时间窗: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)
Baseline data refer to the baseline of core studies (SHP633-306 \[NCT03663582\] or TED-C14-004 \[NCT02340819\]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study.
Number of Participants With Clinically Significant Change From Baseline in Laboratory Values
时间窗: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)
Baseline data refer to the baseline of core studies (SHP633-306 \[NCT03663582\] or TED-C14-004 \[NCT02340819\]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study.
Change From Baseline in 48-Hour Urine Output
时间窗: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)
Baseline data refer to the baseline of core studies (SHP633-306 \[NCT03663582\] or TED-C14-004 \[NCT02340819\]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study.
Number of Participants Who Were Completely Weaned Off PS at End of Study (EOS)
时间窗: From the first dose of study drug (in current study) up to EOS (up to approximately 42 months)
Number of Participants With Clinically Significant Colonoscopy/Sigmoidoscopy Results
时间窗: From the first dose of study drug (in current study) up to EOS (up to approximately 42 months)
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
时间窗: From the first dose of study drug (in current study) up to EOS (up to approximately 42 months)
Number of Participants Who Reported Positive Specific Antibodies to Teduglutide at EOS
时间窗: From the first dose of study drug (in current study) up to EOS (up to approximately 42 months)
Number of Participants With Clinically Significant Change From Baseline in Body Weight Measurements
时间窗: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)
Baseline data refer to the baseline of core studies (SHP633-306 \[NCT03663582\] or TED-C14-004 \[NCT02340819\]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study.
Number of Participants With Clinically Significant Change From Baseline in BMI
时间窗: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)
Baseline data refer to the baseline of core studies (SHP633-306 \[NCT03663582\] or TED-C14-004 \[NCT02340819\]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study.
次要结局
未报告次要终点