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A Study in Japanese Children With Short Bowel Syndrome Who Completed SHP633-302

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ClinicalTrials.gov Identifier: NCT03268811
Recruitment Status : Recruiting
First Posted : August 31, 2017
Last Update Posted : September 25, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
A study in Japanese Children with Short Bowel Syndrome Who Completed SHP633-302

Condition or disease Intervention/treatment Phase
Short Bowel Syndrome Drug: Teduglutide Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Open-label, Long-term Safety and Efficacy Study of Teduglutide in Japanese Pediatric Subjects With Short Bowel Syndrome Who Completed SHP633-302
Actual Study Start Date : August 16, 2017
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Teduglutide
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Teduglutide
Standard of care (SOC) treatment +/- teduglutide. Depending on teduglutide treatment eligibility, subjects may receive teduglutide 0.05 mg/kg subcutaneous once daily for 24-week intervals.
Drug: Teduglutide
Teduglutide 0.05 mg/kg SC injection once daily.


Outcome Measures

Primary Outcome Measures :
  1. Number of Participants With Adverse Events (AE) [ Time Frame: From start of treatment up to follow up (Week 28) ]
    An AE is any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment.administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment.

  2. Number of Participants With Gastrointestinal (GI) Symptoms Reported as an Adverse Event [ Time Frame: From start of treatment up to follow up (Week 28) ]
    An AE is any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment.administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. Events specific with the GI symptoms and reported as AE will be considered for reporting.

  3. Number of Participants With Clinically Significant Abnormalities in Vital Signs Reported as an Adverse Event [ Time Frame: From start of treatment up to follow up (Week 28) ]
    Vital signs included systolic and diastolic blood pressure, pulse and body temperature. Clinically significant value defines if the change is clinically relevant or if, during treatment with investigational product, a shift of a parameter is observed from a normal value to an abnormal value, or a further worsening of an already abnormal value.

  4. Number of Participants With Clinically Significant Lab and Safety Analysis Reported as an Adverse Event [ Time Frame: From start of treatment up to follow up (Week 28) ]
    Lab and safety analysis included biochemistry, hematology and urinalysis. Clinically significant value defines if the change is clinically relevant or if, during treatment with investigational product, a shift of a parameter is observe d from a normal value to an abnormal value, or a further worsening of an already abnormal value.

  5. Number of Participants With Significant Change in Urine Output Reported as an Adverse Event [ Time Frame: From start of treatment up to follow up (Week 28) ]
    Urine output will be recorded in the output diary over a 48-hour period of parenteral support (PS) stability before every clinic visit.

  6. Number of Participants With Significant Change in Stool Output Reported as an Adverse Event [ Time Frame: From start of treatment up to follow up (Week 28) ]
    Stool output will be recorded in the output diary over a 48-hour period of PS stability before every clinic visit.

  7. Number of Participants With Positive Specific or Neutralizing Antibodies to Teduglutide Reported as an Adverse Event [ Time Frame: From start of treatment up to follow up (Week 28) ]
    Blood samples will be drawn for the analysis of positive/specific antibodies to teduglutide according to the study schedules.

  8. Number of Participants With a Positive Fecal Occult Blood Testing [ Time Frame: From start of treatment till EOT (up to 24 Weeks) ]
    Gastrointestinal-specific assessment will be analysed by fecal occult blood testing. Subjects with newly positive fecal occult blood testing results at the pre-treatment visit for which a readily detectable cause cannot be identified (example: anal fissure ) will undergo a colonoscopy prior to receiving teduglutide.

  9. Change From Baseline to Week 28 in Z-Score Body Weight [ Time Frame: From start of treatment up to follow up (Week 28) ]
    The Z-score indicates the number of standard deviations away from the mean.

  10. Change From Baseline to Week 28 in Z-Score Height [ Time Frame: From start of treatment up to follow up (Week 28) ]
    The Z-score indicates the number of standard deviations away from the mean.

  11. Change From Baseline to Week 28 in Z-Score Head Circumference [ Time Frame: From start of treatment up to follow up (Week 28) ]
    The Z-score indicates the number of standard deviations away from the mean.

  12. Change From Baseline to Week 28 in Z-Score Body Mass Index (BMI) [ Time Frame: From start of treatment up to follow up (Week 28) ]
    The Z-score indicates the number of standard deviations away from the mean.


Secondary Outcome Measures :
  1. Percent Reduction in Parenteral Support (PS) Volume [ Time Frame: Week 24 or end of treatment [EOT] ]
    PS (parenteral nutrition or intravenous fluids) will be considered for managing nutritional support in terms of volume and calories during the treatment period. PS volume of at least 20 percent (%) will be considered for the analysis.

  2. Absolute Change in Parenteral Support (PS) Volume at Week 24/End of Treatment [EOT] [ Time Frame: Week 24/EOT ]
    PS (parenteral nutrition or intravenous fluids) will be considered for managing nutritional support in terms of volume and calories during the treatment period.

  3. Relative Change in Parenteral Support (PS) Volume at Week 24/End of Treatment [EOT] [ Time Frame: Week 24/EOT ]
    PS (parenteral nutrition or intravenous fluids) will be considered for managing nutritional support in terms of volume and calories during the treatment period.

  4. Complete Weaning Off Parenteral Support (PS) [ Time Frame: Week 24/EOT ]
    PS (parenteral nutrition or intravenous fluids) will be considered for managing nutritional support in terms of volume and calories during the treatment period. Weaning will be calculated as per the protocol mentioned algorithm.

  5. Change in Days per Week of Parenteral Support (PS) [ Time Frame: Week 24/EOT ]
    PS (parenteral nutrition or intravenous fluids) will be considered for managing nutritional support in terms of volume and calories during the treatment period. Change in PS was calculated in days per week.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject provides written informed consent (subject, parent or legal guardian and, as appropriate, informed assent) to participate in the study before completing any study-related procedures.
  • When applicable, informed assent (as deemed appropriate by the Institutional Review Board [IRB]) by the subject prior to any study-related procedures.
  • Subject completed Study SHP633-302 (NCT02980666).
  • Subject (and/or parent/legally authorized representative) understands and is willing and able to fully adhere to study requirements as defined in this protocol.

Exclusion Criteria:

There are no exclusion criteria for this study.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03268811


Contacts
Contact: Shire Contact 1 866-842-5335 ClinicalTransparency@shire.com

Locations
Japan
Kagoshima University Hospital Recruiting
Kagoshima, Kagoshima-Ken, Japan, 890-8520
Contact: Tatsuru Kaji    +81992755111    tatu@m2.kufm.kagoshima-u.ac.jp   
Principal Investigator: Tatsuru Kaji         
Sponsors and Collaborators
Shire
Investigators
Study Director: Shire Physician Shire
More Information

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT03268811     History of Changes
Other Study ID Numbers: SHP633-305
First Posted: August 31, 2017    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Syndrome
Short Bowel Syndrome
Disease
Pathologic Processes
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Postoperative Complications