Short Bowel Syndrome
Conditions
Keywords
Parenteral nutrition, TPN, HPN, PN, SBS, Short bowel syndrome
Brief summary
This study is a 1-year open label extension study to collect long term efficacy and safety data from patients who have completed approximately 2 years of dosing in Study CL0600-021.
Detailed description
This study served as a 1-year extension study for those US patients who have completed the CL0600-021 study.
Interventions
DRUGTeduglutide
0.05 mg/kg/day subcutaneously taken once per day for 12 months
Sponsors
Shire
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At completion of Study CL0600-021, subjects will be invited to participate in this trial if they meet the following criteria: 1. Completion of the 24-month study, CL0600-021, regardless if fully weaned from PN/I.V. support 2. Signed and dated informed consent form (ICF) to participate before any study-related procedures of Study TED-C11-001 are performed
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Summary of Treatment-emergent Adverse Events | 12 months | As the primary intent of this study was to collect additional safety data, this outcomes measure will provide a summary of the treatment emergent adverse events. Based on the start date of each subject in this study and the study end date, not all subjects reached 12 months. |
Countries
United States
Participant flow
Recruitment details
This was a 1-year, open-label, multi-center study in subjects who completed Study CL0600-021 (NCT00930644) at any US site.
Participants by arm
| Arm | Count |
|---|---|
| TED/TED This group represents those subjects exposed to active treatment with teduglutide for 24 weeks in Study CL0600-020 (NCT00798967) and an additional 24 months in Study CL0600 021 (NCT00930644) | 5 |
| NT/PBO,TED This group represents those subjects who either participated in Study CL0600-020 and received placebo, or who were eligible for randomization in Study CL0600-020 (NCT00798967), but qualified after the enrollment number was already satisfied and therefore entered the open-label extension Study CL0600-021 (NCT00930644) directly | 9 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | TED/TED | NT/PBO,TED | Total |
|---|---|---|---|
| Age, Customized 45 - < 65 years | 3 Participants | 6 Participants | 9 Participants |
| Age, Customized < 45 years | 1 Participants | 2 Participants | 3 Participants |
| Age, Customized >=65 years | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Female | 4 Participants | 6 Participants | 10 Participants |
| Sex: Female, Male Male | 1 Participants | 3 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 9 | 4 / 5 |
| serious Total, serious adverse events | 1 / 9 | 5 / 5 |
Outcome results
Primary
Summary of Treatment-emergent Adverse Events
As the primary intent of this study was to collect additional safety data, this outcomes measure will provide a summary of the treatment emergent adverse events. Based on the start date of each subject in this study and the study end date, not all subjects reached 12 months.
Time frame: 12 months
Population: Safety Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NT,PBO/TED | Summary of Treatment-emergent Adverse Events | 4 participants |
| TED/TED | Summary of Treatment-emergent Adverse Events | 5 participants |